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Omeprazole

Over-the-counter ANDA RLD Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Omeprazole
Generic name
Omeprazole
Dosage form
Tablet, Delayed Release
Route
Oral
Marketing category
ANDA · ANDA
Labeler
PLD Acquisitions LLC DBA Avma Pharma Solutions
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
64
Packages
145
Data completeness
82% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Omeprazole 20 mg/1 200329 View
Omeprazole Magnesium 20 mg/1 198051 View
Omeprazole Magnesium 20.6 mg/1 198051 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Delayed Release
Route of administration
Oral
Presentations
209

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Cytochrome P450 2C19 Inhibitors [MoA] MoA All 93 members
Proton Pump Inhibitor [EPC] EPC All 74 members
Proton Pump Inhibitors [MoA] MoA All 74 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
022032
Application type
ANDA · Abbreviated New Drug Application
Approval date
December 4, 2007
Sponsor
DEXCEL PHARMA
Products on application
1
Submissions recorded
27
Products approved under application 022032.
Product Trade name Form Strength Ingredient Status TE Flags
022032-001 OMEPRAZOLE TABLET, DELAYED RELEASE OMEPRAZOLE Over-the-counter — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
12599565 January 31, 2030 001 No May 11, 2026

Approval history

Source: Drugs@FDA
Most recent submissions on application 022032.
Type No. Action Status Date Review
Supplement 70 Manufacturing (CMC) Approved October 3, 2025 N/A
Supplement 65 Manufacturing (CMC) Approved November 8, 2024 N/A
Supplement 57 Labeling Approved September 30, 2022 Standard
Supplement 52 Manufacturing (CMC) Approved October 21, 2021 N/A
Supplement 46 Labeling Approved July 7, 2021 Standard
Supplement 41 Labeling Approved April 8, 2019 Standard
Supplement 38 Labeling Approved November 13, 2017 Standard
Supplement 37 Labeling Approved October 30, 2017 Standard
Supplement 34 Manufacturing (CMC) Approved December 1, 2016 Standard
Supplement 32 Labeling Approved February 10, 2016 Standard
Supplement 31 Manufacturing (CMC) Approved February 8, 2016 Standard
Supplement 25 Manufacturing (CMC) Approved January 5, 2016 Standard
Supplement 26 Manufacturing (CMC) Approved August 7, 2015 Standard
Supplement 29 Labeling Approved June 11, 2015 Standard
Supplement 28 Manufacturing (CMC) Approved June 1, 2015 Standard
Supplement 27 Manufacturing (CMC) Approved March 30, 2015 Standard
Supplement 24 Manufacturing (CMC) Approved March 6, 2015 Standard
Supplement 22 Manufacturing (CMC) Approved September 13, 2013 Standard
Supplement 21 Labeling Approved August 16, 2013 Standard
Supplement 20 Labeling Approved October 29, 2012 Standard
Supplement 19 Labeling Approved September 10, 2012 Standard
Supplement 16 Labeling Approved April 9, 2012 Standard
Supplement 12 Labeling Approved June 27, 2011 Unknown
Supplement 8 Labeling Approved July 16, 2010 Standard
Supplement 4 Manufacturing (CMC) Approved September 21, 2009 N/A
Supplement 3 Labeling Approved April 2, 2009 Standard
Original application 1 Type 5 - New Formulation or New Manufacturer Approved December 4, 2007 Standard

Review documents

  • 0 · Supplement · October 7, 2025
  • 0 · Supplement · October 6, 2025
  • 0 · Supplement · March 24, 2025
  • 0 · Supplement · November 12, 2024
  • 0 · Supplement · November 12, 2024
  • 0 · Supplement · October 17, 2022
  • 0 · Supplement · October 13, 2022
  • 0 · Supplement · October 5, 2022
  • 0 · Supplement · October 3, 2022
  • 0 · Supplement · July 8, 2021
  • 0 · Supplement · April 10, 2019
  • 0 · Supplement · April 10, 2019
  • 0 · Supplement · November 15, 2017
  • 0 · Supplement · November 14, 2017
  • 0 · Supplement · November 13, 2017
  • 0 · Supplement · November 6, 2017
  • 0 · Supplement · February 11, 2016
  • 0 · Supplement · February 11, 2016
  • 0 · Supplement · June 19, 2015
  • 0 · Supplement · June 12, 2015
  • 0 · Supplement · March 12, 2015
  • 0 · Supplement · March 10, 2015
  • 0 · Supplement · January 15, 2014
  • 0 · Supplement · September 19, 2013
  • 0 · Supplement · August 20, 2013
  • 0 · Supplement · October 30, 2012
  • 0 · Supplement · September 11, 2012
  • 0 · Supplement · April 11, 2012
  • 0 · Supplement · July 5, 2011
  • 0 · Supplement · July 23, 2010

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260204). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260204 HUMAN OTC DRUG · 20251208 HUMAN OTC DRUG · 20251030 HUMAN OTC DRUG · 20250319

Indications and Usage

openFDA Drug Labeling

Use(s) • treats frequent heartburn (occurs 2 or more days a week) • not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Purpose Acid reducer

Dosage and Administration

openFDA Drug Labeling

Directions • for adults 18 years of age and older ■ this product is to be used once a day (every 24 hours), every day for 14 days ■ it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours 14-Day Course of Treatment ■ swallow 1 tablet with a glass of water before eating in the morning ■ take every day for 14 days ■ do not take more than 1 tablet a day ■ do not use for more than 14 days unless directed by your doctor ■ swallow whole. Do not chew or crush tablets. Repeated 14-Day Courses (if needed) ■ you may repeat a 14-day course every 4 months ■ do not take for more than 14 days or more often than every 4 months unless directed by a doctor ■ children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition. Other information • read the directions and warnings before use ■ keep the carton. It contains important information. ■ store at 20 to 25° C (68 to 77° F) and protect from moisture

Warnings Allergy alert: • do not use if you are allergic to omeprazole. • omeprazole may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If an allergic reaction occurs, stop use and seek medical help right away. Do not use if you have : • trouble or pain swallowing food, vomiting with blood, or bloody or black stools • heartburn with lightheadedness, sweating or dizziness • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness • frequent chest pain These may be signs of a serious condition. See your doctor. Ask a doctor before use if you have: • had heartburn over 3 months. This may be a sign of a more serious condition. • frequent wheezing, particularly with heartburn • unexplained weight loss • nausea or vomiting • stomach pain Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs. Stop use and ask a doctor if: • your heartburn continues or worsens • you need to take this product for more than 14 days • you need to take more than 1 course of treatment every 4 months • you get diarrhea • you develop a rash or joint pain If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Do not use if you have : • trouble or pain swallowing food, vomiting with blood, or bloody or black stools • heartburn with lightheadedness, sweating or dizziness • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness • frequent chest pain These may be signs of a serious condition. See your doctor.

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have: • had heartburn over 3 months. This may be a sign of a more serious condition. • frequent wheezing, particularly with heartburn • unexplained weight loss • nausea or vomiting • stomach pain

Stop use and ask a doctor if: • your heartburn continues or worsens • you need to take this product for more than 14 days • you need to take more than 1 course of treatment every 4 months • you get diarrhea • you develop a rash or joint pain

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each tablet) Omeprazole delayed-release tablet, 20 mg (equivalent to 20.6 mg omeprazole magnesium USP)

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Product: 50090-6888 NDC: 50090-6888-0 14 TABLET, DELAYED RELEASE in a BOTTLE / 2 in a CARTON

Adverse event reports

Source: openFDA FAERS
448,269
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: OMEPRAZOLE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
50090-6888-0 50090-6888 A-S Medication Solutions 2 BOTTLE in 1 CARTON (50090-6888-0) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE December 6, 2023
46122-739-04 46122-739 AMERISOURCEBERGEN DRUG CORPORATION 3 BOTTLE in 1 CARTON (46122-739-04) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE August 30, 2023
46122-739-74 46122-739 AMERISOURCEBERGEN DRUG CORPORATION 1 BOTTLE in 1 CARTON (46122-739-74) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE August 30, 2023
69168-476-14 69168-476 Allegiant Health 1 BOTTLE in 1 CARTON (69168-476-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE March 21, 2025
69168-476-15 69168-476 Allegiant Health 14 TABLET, DELAYED RELEASE in 1 BOTTLE (69168-476-15) March 21, 2025
69168-476-42 69168-476 Allegiant Health 3 BOTTLE in 1 CARTON (69168-476-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE March 21, 2025
69168-476-61 69168-476 Allegiant Health 1 BOTTLE in 1 CARTON (69168-476-61) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE March 21, 2025
72288-934-01 72288-934 Amazon.com Services LLC 1 BOTTLE in 1 CARTON (72288-934-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (72288-934-00) August 30, 2026
59651-050-22 59651-050 Aurobindo Pharma Limited 2000 TABLET, DELAYED RELEASE in 1 BAG (59651-050-22) June 6, 2018
37835-001-14 37835-001 BI-MART 1 BOTTLE in 1 CARTON (37835-001-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE September 30, 2019
37835-001-42 37835-001 BI-MART 3 BOTTLE in 1 CARTON (37835-001-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE September 30, 2019
68001-441-39 68001-441 BluePoint Laboratories 2 BOTTLE in 1 CARTON (68001-441-39) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (68001-441-55) June 19, 2020
68001-441-40 68001-441 BluePoint Laboratories 3 BOTTLE in 1 CARTON (68001-441-40) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (68001-441-55) June 19, 2020
68001-441-98 68001-441 BluePoint Laboratories 1 BOTTLE in 1 CARTON (68001-441-98) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (68001-441-55) June 19, 2020
83324-011-14 83324-011 CHAIN DRUG MARKETING ASSOCIATION, INC. 1 CONTAINER in 1 CARTON (83324-011-14) / 14 TABLET, DELAYED RELEASE in 1 CONTAINER May 10, 2024
83324-011-42 83324-011 CHAIN DRUG MARKETING ASSOCIATION, INC. 3 CONTAINER in 1 CARTON (83324-011-42) / 14 TABLET, DELAYED RELEASE in 1 CONTAINER May 10, 2024
59779-503-01 59779-503 CVS Pharmacy 1 BOTTLE in 1 CARTON (59779-503-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE February 29, 2012
59779-503-03 59779-503 CVS Pharmacy 3 BOTTLE in 1 CARTON (59779-503-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE February 28, 2012
59779-503-55 59779-503 CVS Pharmacy 3 CARTON in 1 CARTON (59779-503-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK March 5, 2008
59779-580-01 59779-580 CVS Pharmacy 1 BOTTLE in 1 CARTON (59779-580-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE March 31, 2015
59779-580-03 59779-580 CVS Pharmacy 3 BOTTLE in 1 CARTON (59779-580-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE March 27, 2015
69842-661-01 69842-661 CVS Pharmacy 1 BOTTLE in 1 CARTON (69842-661-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE March 28, 2022
69842-661-03 69842-661 CVS Pharmacy 3 BOTTLE in 1 CARTON (69842-661-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE March 28, 2022
69230-318-05 69230-318 Camber Consumer Care Inc 500 TABLET, DELAYED RELEASE in 1 BOTTLE (69230-318-05) October 29, 2020
69230-318-10 69230-318 Camber Consumer Care Inc 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (69230-318-10) October 29, 2020
69230-318-32 69230-318 Camber Consumer Care Inc 1 BLISTER PACK in 1 CARTON (69230-318-32) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK March 25, 2020
69230-318-33 69230-318 Camber Consumer Care Inc 2 BLISTER PACK in 1 CARTON (69230-318-33) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK March 25, 2020
69230-318-34 69230-318 Camber Consumer Care Inc 3 BLISTER PACK in 1 CARTON (69230-318-34) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK March 25, 2020
69230-318-35 69230-318 Camber Consumer Care Inc 1 BOTTLE in 1 CARTON (69230-318-35) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE March 25, 2020
69230-318-36 69230-318 Camber Consumer Care Inc 2 BOTTLE in 1 CARTON (69230-318-36) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE March 25, 2020
69230-318-37 69230-318 Camber Consumer Care Inc 3 BOTTLE in 1 CARTON (69230-318-37) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE March 25, 2020
83324-141-14 83324-141 Chain Drug Marketing Association INC 1 BOTTLE in 1 CARTON (83324-141-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE April 1, 2025
83324-141-42 83324-141 Chain Drug Marketing Association INC 3 BOTTLE in 1 CARTON (83324-141-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE April 1, 2025
64239-303-05 64239-303 Dexcel Pharma Technologies Ltd. 10 BLISTER PACK in 1 CARTON (64239-303-05) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK September 30, 2011
64239-399-08 64239-399 Dexcel Pharma Technologies Ltd. 10 BLISTER PACK in 1 CARTON (64239-399-08) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK March 6, 2015
53943-038-14 53943-038 Discount Drug Mart, Inc 1 BOTTLE in 1 CARTON (53943-038-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE September 1, 2026
53943-038-42 53943-038 Discount Drug Mart, Inc 3 BOTTLE in 1 CARTON (53943-038-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE September 1, 2026
43598-286-25 43598-286 Dr. Reddys Laboratories Inc 2 BLISTER PACK in 1 CARTON (43598-286-25) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK November 6, 2018
43598-286-27 43598-286 Dr. Reddys Laboratories Inc 2 BOTTLE in 1 CARTON (43598-286-27) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (43598-286-52) November 6, 2018
43598-286-32 43598-286 Dr. Reddys Laboratories Inc 2 BLISTER PACK in 1 CARTON (43598-286-32) / 7 TABLET, DELAYED RELEASE in 1 BLISTER PACK (43598-286-70) November 6, 2018
43598-286-33 43598-286 Dr. Reddys Laboratories Inc 3 BOTTLE in 1 CARTON (43598-286-33) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (43598-286-52) November 6, 2018
43598-286-37 43598-286 Dr. Reddys Laboratories Inc 3 BLISTER PACK in 1 CARTON (43598-286-37) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK November 6, 2018
43598-286-52 43598-286 Dr. Reddys Laboratories Inc 14 TABLET, DELAYED RELEASE in 1 BOTTLE (43598-286-52) November 6, 2018
43598-286-74 43598-286 Dr. Reddys Laboratories Inc 1 BLISTER PACK in 1 CARTON (43598-286-74) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK November 6, 2018
43598-286-86 43598-286 Dr. Reddys Laboratories Inc 3500 TABLET, DELAYED RELEASE in 1 POUCH (43598-286-86) November 6, 2018
43598-841-42 43598-841 Dr. Reddys Laboratories Inc 3 BOTTLE in 1 CARTON (43598-841-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE October 1, 2020
43598-841-52 43598-841 Dr. Reddys Laboratories Inc 1 BOTTLE in 1 CARTON (43598-841-52) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE October 1, 2020
55319-219-14 55319-219 Family Dollar (FAMILY WELLNESS) 1 BOTTLE, PLASTIC in 1 BOX (55319-219-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC February 28, 2025
57896-659-42 57896-659 GERI-CARE PHARMACEUTICALS, CORP 3 BOTTLE in 1 CARTON (57896-659-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (57896-659-14) May 23, 2024
37808-401-01 37808-401 H E B 1 BOTTLE in 1 CARTON (37808-401-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE April 3, 2015
37808-401-03 37808-401 H E B 3 BOTTLE in 1 CARTON (37808-401-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE April 3, 2015
37808-915-01 37808-915 H E B 1 BOTTLE in 1 CARTON (37808-915-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE February 4, 2011
37808-915-03 37808-915 H E B 3 BOTTLE in 1 CARTON (37808-915-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE April 27, 2021
37808-915-30 37808-915 H E B 2 CARTON in 1 CARTON (37808-915-30) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK February 29, 2008
59640-047-03 59640-047 H E B 3 BOTTLE in 1 CARTON (59640-047-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (59640-047-01) March 28, 2022
61269-720-14 61269-720 H2-Pharma, LLC 1 BOTTLE in 1 CARTON (61269-720-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE August 4, 2026
61269-720-42 61269-720 H2-Pharma, LLC 3 BOTTLE in 1 CARTON (61269-720-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE August 4, 2026
72036-981-14 72036-981 HARRIS TEETER 1 BOTTLE in 1 CARTON (72036-981-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE September 16, 2020
72036-981-42 72036-981 HARRIS TEETER 3 BOTTLE in 1 CARTON (72036-981-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE September 16, 2020
42507-414-01 42507-414 HyVee Inc 1 BOTTLE in 1 CARTON (42507-414-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (42507-414-00) January 28, 2026
42507-414-42 42507-414 HyVee Inc 3 BOTTLE in 1 CARTON (42507-414-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (42507-414-00) January 28, 2026
42507-915-01 42507-915 HyVee Inc 1 BOTTLE in 1 CARTON (42507-915-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (42507-915-00) March 2, 2008
42507-915-03 42507-915 HyVee Inc 3 BOTTLE in 1 CARTON (42507-915-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (42507-915-00) March 2, 2008
42507-915-55 42507-915 HyVee Inc 3 CARTON in 1 CARTON (42507-915-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK March 2, 2008
42507-915-74 42507-915 HyVee Inc 14 BLISTER PACK in 1 CARTON (42507-915-74) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK March 2, 2008
57483-840-42 57483-840 INNOVUS PHARMACEUTICALS, INC. 3 BOTTLE in 1 CARTON (57483-840-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (57483-840-01) August 10, 2020
30142-474-01 30142-474 Kroger Company 1 BOTTLE in 1 CARTON (30142-474-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE May 5, 2025
30142-557-01 30142-557 Kroger Company 1 BOTTLE in 1 CARTON (30142-557-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE October 8, 2010
30142-557-03 30142-557 Kroger Company 3 BOTTLE in 1 CARTON (30142-557-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE January 3, 2012
30142-557-55 30142-557 Kroger Company 3 CARTON in 1 CARTON (30142-557-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK February 25, 2008
30142-557-74 30142-557 Kroger Company 14 BLISTER PACK in 1 CARTON (30142-557-74) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK February 25, 2008
30142-593-01 30142-593 Kroger Company 1 BOTTLE in 1 CARTON (30142-593-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE February 9, 2017
30142-593-03 30142-593 Kroger Company 3 BOTTLE in 1 CARTON (30142-593-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE February 9, 2017
72559-014-06 72559-014 Little Pharma, Inc. 3 BOTTLE in 1 CARTON (72559-014-06) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE July 15, 2020
72559-014-07 72559-014 Little Pharma, Inc. 1 BOTTLE in 1 CARTON (72559-014-07) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE July 15, 2020
72559-014-09 72559-014 Little Pharma, Inc. 3 CARTON in 1 PACKAGE, COMBINATION (72559-014-09) / 3 BOTTLE in 1 CARTON / 14 TABLET, DELAYED RELEASE in 1 BOTTLE March 31, 2026
72559-014-36 72559-014 Little Pharma, Inc. 4 CARTON in 1 PACKAGE, COMBINATION (72559-014-36) / 3 BOTTLE in 1 CARTON / 14 TABLET, DELAYED RELEASE in 1 BOTTLE June 18, 2024
21130-991-28 21130-991 Living Better Brands LLC 2 BLISTER PACK in 1 CARTON (21130-991-28) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK June 1, 2019
21130-991-44 21130-991 Living Better Brands LLC 1 BLISTER PACK in 1 CARTON (21130-991-44) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK June 1, 2019
41250-401-01 41250-401 Meijer Distribution Inc 1 BOTTLE in 1 CARTON (41250-401-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE February 3, 2020
41250-401-03 41250-401 Meijer Distribution Inc 3 BOTTLE in 1 CARTON (41250-401-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE March 25, 2015
41250-915-01 41250-915 Meijer Distribution Inc 1 BOTTLE in 1 CARTON (41250-915-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE March 23, 2011
41250-915-02 41250-915 Meijer Distribution Inc 2 BOTTLE in 1 CARTON (41250-915-02) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE September 2, 2011
41250-915-03 41250-915 Meijer Distribution Inc 3 BOTTLE in 1 CARTON (41250-915-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE September 2, 2011
41250-915-55 41250-915 Meijer Distribution Inc 3 CARTON in 1 CARTON (41250-915-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK February 29, 2008
51660-029-14 51660-029 OHM LABORATORIES INC. 1 BOTTLE in 1 CARTON (51660-029-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE June 1, 2019
51660-029-27 51660-029 OHM LABORATORIES INC. 2 BOTTLE in 1 CARTON (51660-029-27) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE June 1, 2019
51660-029-44 51660-029 OHM LABORATORIES INC. 3 BOTTLE in 1 CARTON (51660-029-44) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE June 1, 2019
59726-298-14 59726-298 P & L Development, LLC 1 BOTTLE, PLASTIC in 1 BOX (59726-298-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC January 31, 2025
59726-740-42 59726-740 P & L Development, LLC 3 BOTTLE, PLASTIC in 1 BOX (59726-740-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC August 15, 2025
59726-744-14 59726-744 P & L Development, LLC 1 BOTTLE, PLASTIC in 1 BOX (59726-744-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC August 29, 2025
59726-744-42 59726-744 P & L Development, LLC 3 BOTTLE, PLASTIC in 1 BOX (59726-744-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC August 29, 2025
63548-2970-2 63548-2970 PLD Acquisitions LLC DBA Avma Pharma Solutions 1 BOTTLE, PLASTIC in 1 BOX (63548-2970-2) / 42 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC October 31, 2024
63548-2970-4 63548-2970 PLD Acquisitions LLC DBA Avma Pharma Solutions 1 BOTTLE, PLASTIC in 1 BOX (63548-2970-4) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC October 31, 2024
63548-2970-8 63548-2970 PLD Acquisitions LLC DBA Avma Pharma Solutions 1 BOTTLE, PLASTIC in 1 BOX (63548-2970-8) / 28 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC October 31, 2024
63548-2971-0 63548-2971 PLD Acquisitions LLC DBA Avma Pharma Solutions 1000000 DRUM in 1 DRUM (63548-2971-0) / 1000000 TABLET, DELAYED RELEASE in 1 DRUM June 1, 2025
63548-4080-2 63548-4080 PLD Acquisitions LLC DBA Avma Pharma Solutions 42 BLISTER PACK in 1 CARTON (63548-4080-2) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK October 31, 2024
63548-4080-4 63548-4080 PLD Acquisitions LLC DBA Avma Pharma Solutions 14 BLISTER PACK in 1 CARTON (63548-4080-4) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK October 31, 2024
63548-4080-8 63548-4080 PLD Acquisitions LLC DBA Avma Pharma Solutions 28 BLISTER PACK in 1 CARTON (63548-4080-8) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK October 31, 2024
63548-7370-2 63548-7370 PLD Acquisitions LLC DBA Avma Pharma Solutions 1 BOTTLE, PLASTIC in 1 BOX (63548-7370-2) / 42 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC October 31, 2024
63548-7370-4 63548-7370 PLD Acquisitions LLC DBA Avma Pharma Solutions 1 BOTTLE, PLASTIC in 1 BOX (63548-7370-4) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC October 31, 2024
63548-7370-8 63548-7370 PLD Acquisitions LLC DBA Avma Pharma Solutions 1 BOTTLE, PLASTIC in 1 BOX (63548-7370-8) / 28 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC October 31, 2024
63548-8040-2 63548-8040 PLD Acquisitions LLC DBA Avma Pharma Solutions 42 BLISTER PACK in 1 CARTON (63548-8040-2) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK October 31, 2024
63548-8040-4 63548-8040 PLD Acquisitions LLC DBA Avma Pharma Solutions 14 BLISTER PACK in 1 CARTON (63548-8040-4) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK October 31, 2024
63548-8040-8 63548-8040 PLD Acquisitions LLC DBA Avma Pharma Solutions 28 BLISTER PACK in 1 CARTON (63548-8040-8) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK October 31, 2024
45802-888-30 45802-888 Padagis Israel Pharmaceuticals Ltd 2 CARTON in 1 CARTON (45802-888-30) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK February 25, 2008
45802-888-55 45802-888 Padagis Israel Pharmaceuticals Ltd 3 CARTON in 1 CARTON (45802-888-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK November 6, 2008
56062-401-01 56062-401 Publix Super Markets Inc 1 BOTTLE in 1 CARTON (56062-401-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE July 11, 2022
56062-401-03 56062-401 Publix Super Markets Inc 3 BOTTLE in 1 CARTON (56062-401-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE July 1, 2022
56062-915-30 56062-915 Publix Super Markets Inc 2 CARTON in 1 CARTON (56062-915-30) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK May 15, 2008
56062-915-55 56062-915 Publix Super Markets Inc 3 CARTON in 1 CARTON (56062-915-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK May 14, 2008
56062-915-74 56062-915 Publix Super Markets Inc 14 BLISTER PACK in 1 CARTON (56062-915-74) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK May 12, 2008
67296-2183-8 67296-2183 Redpharm Drug 2 BOTTLE in 1 CARTON (67296-2183-8) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE June 1, 2019
11822-0453-2 11822-0453 Rite Aid Corporation 1 BOTTLE in 1 CARTON (11822-0453-2) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE March 20, 2017
11822-1190-1 11822-1190 Rite Aid Corporation 3 BOTTLE in 1 CARTON (11822-1190-1) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (11822-1190-0) April 13, 2022
70677-1098-1 70677-1098 STRATEGIC SOURCING SERVICES LLC 1 BLISTER PACK in 1 CARTON (70677-1098-1) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK August 11, 2023
70677-0148-1 70677-0148 Strategic Sourcing Services 1 BLISTER PACK in 1 CARTON (70677-0148-1) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK January 1, 2019
62756-377-11 62756-377 Sun Pharmaceutical Industries, Inc. 2 BOTTLE in 1 CARTON (62756-377-11) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE January 1, 2019
62756-377-12 62756-377 Sun Pharmaceutical Industries, Inc. 3 BOTTLE in 1 CARTON (62756-377-12) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE January 1, 2019
62756-377-21 62756-377 Sun Pharmaceutical Industries, Inc. 1 BOTTLE in 1 CARTON (62756-377-21) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE January 1, 2019
62756-377-70 62756-377 Sun Pharmaceutical Industries, Inc. 1 BLISTER PACK in 1 CARTON (62756-377-70) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK January 1, 2019
62756-377-79 62756-377 Sun Pharmaceutical Industries, Inc. 3 BLISTER PACK in 1 CARTON (62756-377-79) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK January 1, 2019
62756-377-96 62756-377 Sun Pharmaceutical Industries, Inc. 2 BLISTER PACK in 1 CARTON (62756-377-96) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK January 1, 2019
30142-992-14 30142-992 THE KROGER COMPANY 14 TABLET, DELAYED RELEASE in 1 BOTTLE (30142-992-14) July 15, 2020
30142-992-28 30142-992 THE KROGER COMPANY 2 TABLET, DELAYED RELEASE in 1 CARTON (30142-992-28) July 15, 2020
55681-306-14 55681-306 Twin Med LLC 1 BOTTLE in 1 CARTON (55681-306-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE April 14, 2022
55681-306-42 55681-306 Twin Med LLC 3 BOTTLE in 1 CARTON (55681-306-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE April 14, 2022
63941-997-14 63941-997 VALU MERCHANDISERS COMPANY 1 BOTTLE in 1 CARTON (63941-997-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE July 21, 2018
63941-997-42 63941-997 VALU MERCHANDISERS COMPANY 3 BOTTLE in 1 CARTON (63941-997-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE July 21, 2018
79903-377-14 79903-377 WALMART INC. (see also Equate) 1 BOTTLE, PLASTIC in 1 BOX (79903-377-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC April 30, 2025
79903-377-42 79903-377 WALMART INC. (see also Equate) 3 BOTTLE, PLASTIC in 1 BOX (79903-377-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC April 30, 2025
0363-0007-01 0363-0007 Walgreen Company 14 TABLET, DELAYED RELEASE in 1 BOTTLE (0363-0007-01) March 25, 2015
0363-0007-03 0363-0007 Walgreen Company 3 BOTTLE in 1 CARTON (0363-0007-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE March 25, 2015
0363-0915-01 0363-0915 Walgreen Company 1 BOTTLE in 1 CARTON (0363-0915-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE October 6, 2010
0363-0915-03 0363-0915 Walgreen Company 3 BOTTLE in 1 CARTON (0363-0915-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE March 25, 2011
0363-0915-30 0363-0915 Walgreen Company 2 CARTON in 1 CARTON (0363-0915-30) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK February 27, 2008
0363-0915-55 0363-0915 Walgreen Company 3 CARTON in 1 CARTON (0363-0915-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK February 27, 2008
0363-6101-03 0363-6101 Walgreen Company 3 BOTTLE in 1 CARTON (0363-6101-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (0363-6101-01) March 9, 2023
0363-9510-14 0363-9510 Walgreens 1 BOTTLE, PLASTIC in 1 BOX (0363-9510-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC April 30, 2025
0363-1607-14 0363-1607 Walgreens Company 14 TABLET, DELAYED RELEASE in 1 BOTTLE (0363-1607-14) January 15, 2020
0363-1607-28 0363-1607 Walgreens Company 2 BOTTLE in 1 CARTON (0363-1607-28) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (0363-1607-14) January 15, 2020
0363-1607-42 0363-1607 Walgreens Company 3 BOTTLE in 1 CARTON (0363-1607-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (0363-1607-14) January 15, 2020
79903-305-28 79903-305 Walmart Inc. 2 BOTTLE in 1 CARTON (79903-305-28) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (79903-305-14) February 3, 2025
79903-305-41 79903-305 Walmart Inc. 1 BOTTLE in 1 CARTON (79903-305-41) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (79903-305-14) March 28, 2026
67091-464-14 67091-464 WinCo Foods, LLC 1 BOTTLE, PLASTIC in 1 BOX (67091-464-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC January 15, 2026
50090-6888 50090-6888 A-S Medication Solutions — March 25, 2020
46122-739 46122-739 AMERISOURCEBERGEN DRUG CORPORATION — November 6, 2018
69168-476 69168-476 Allegiant Health — March 21, 2025
72288-934 72288-934 Amazon.com Services LLC — August 30, 2026
59651-050 59651-050 Aurobindo Pharma Limited — June 6, 2018
37835-001 37835-001 BI-MART — September 30, 2019
68001-441 68001-441 BluePoint Laboratories — June 19, 2020
83324-011 83324-011 CHAIN DRUG MARKETING ASSOCIATION, INC. — May 10, 2024
59779-503 59779-503 CVS Pharmacy — February 29, 2008
59779-580 59779-580 CVS Pharmacy — March 27, 2015
69842-661 69842-661 CVS Pharmacy — March 28, 2022
69230-318 69230-318 Camber Consumer Care Inc — March 25, 2020
83324-141 83324-141 Chain Drug Marketing Association INC — April 1, 2025
64239-303 64239-303 Dexcel Pharma Technologies Ltd. — March 1, 2008
64239-399 64239-399 Dexcel Pharma Technologies Ltd. — March 1, 2008
53943-038 53943-038 Discount Drug Mart, Inc — September 1, 2026
43598-286 43598-286 Dr. Reddys Laboratories Inc — November 6, 2018
43598-841 43598-841 Dr. Reddys Laboratories Inc — October 1, 2020
55319-219 55319-219 Family Dollar (FAMILY WELLNESS) — February 28, 2025
57896-659 57896-659 GERI-CARE PHARMACEUTICALS, CORP — May 23, 2024
37808-401 37808-401 H E B — April 3, 2015
37808-915 37808-915 H E B — February 29, 2008
59640-047 59640-047 H E B — March 28, 2022
61269-720 61269-720 H2-Pharma, LLC — August 4, 2026
72036-981 72036-981 HARRIS TEETER — September 16, 2020
42507-414 42507-414 HyVee Inc — January 28, 2026
42507-915 42507-915 HyVee Inc — March 2, 2008
57483-840 57483-840 INNOVUS PHARMACEUTICALS, INC. — August 10, 2020
30142-474 30142-474 Kroger Company — May 5, 2025
30142-557 30142-557 Kroger Company — February 25, 2008
30142-593 30142-593 Kroger Company — February 9, 2017
72559-014 72559-014 Little Pharma, Inc. — July 15, 2020
21130-991 21130-991 Living Better Brands LLC — June 1, 2019
41250-401 41250-401 Meijer Distribution Inc — March 25, 2015
41250-915 41250-915 Meijer Distribution Inc — February 29, 2008
51660-029 51660-029 OHM LABORATORIES INC. — June 1, 2019
59726-298 59726-298 P & L Development, LLC — January 31, 2025
59726-740 59726-740 P & L Development, LLC — August 15, 2025
59726-744 59726-744 P & L Development, LLC — August 29, 2025
63548-2970 63548-2970 PLD Acquisitions LLC DBA Avma Pharma Solutions — October 31, 2024
63548-2971 63548-2971 PLD Acquisitions LLC DBA Avma Pharma Solutions — April 30, 2025
63548-4080 63548-4080 PLD Acquisitions LLC DBA Avma Pharma Solutions — October 31, 2024
63548-7370 63548-7370 PLD Acquisitions LLC DBA Avma Pharma Solutions — October 31, 2024
63548-8040 63548-8040 PLD Acquisitions LLC DBA Avma Pharma Solutions — October 31, 2024
45802-888 45802-888 Padagis Israel Pharmaceuticals Ltd — February 25, 2008
56062-401 56062-401 Publix Super Markets Inc — July 1, 2022
56062-915 56062-915 Publix Super Markets Inc — May 12, 2008
67296-2183 67296-2183 Redpharm Drug — June 1, 2019
11822-0453 11822-0453 Rite Aid Corporation — March 26, 2015
11822-1190 11822-1190 Rite Aid Corporation — April 13, 2022
70677-1098 70677-1098 STRATEGIC SOURCING SERVICES LLC — August 11, 2023
70677-0148 70677-0148 Strategic Sourcing Services — January 1, 2019
62756-377 62756-377 Sun Pharmaceutical Industries, Inc. — January 1, 2019
30142-992 30142-992 THE KROGER COMPANY — July 15, 2020
55681-306 55681-306 Twin Med LLC — April 14, 2022
63941-997 63941-997 VALU MERCHANDISERS COMPANY — July 20, 2018
79903-377 79903-377 WALMART INC. (see also Equate) — April 30, 2025
0363-0007 0363-0007 Walgreen Company — March 25, 2015
0363-0915 0363-0915 Walgreen Company — February 27, 2008
0363-6101 0363-6101 Walgreen Company — March 9, 2023
0363-9510 0363-9510 Walgreens — April 30, 2025
0363-1607 0363-1607 Walgreens Company — January 15, 2020
79903-305 79903-305 Walmart Inc. — November 6, 2018
67091-464 67091-464 WinCo Foods, LLC — January 15, 2026

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 13 sections on this page.