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Fexofenadine hydrochloride

Over-the-counter ANDA TE AB 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
Fexofenadine Hydrochloride
Generic name
Fexofenadine hydrochloride
Dosage form
Tablet
Route
—
Marketing category
ANDA · ANDA
Labeler
Dr. Reddy's Laboratories Limited
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
31
Packages
103
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
Fexofenadine Hydrochloride 180 mg/1 997501 View
Fexofenadine Hydrochloride 30 mg/1 997501 View
Fexofenadine Hydrochloride 60 mg/1 997501 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet
Route of administration
—
Presentations
134

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
Histamine H1 Receptor Antagonists [MoA] MoA All 136 members
Histamine-1 Receptor Antagonist [EPC] EPC All 134 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
076502
Application type
ANDA · Abbreviated New Drug Application
Approval date
April 11, 2006
Sponsor
DR REDDYS LABS LTD
Products on application
9
Submissions recorded
5
Products approved under application 076502.
Product Trade name Form Strength Ingredient Status TE Flags
076502-001 FEXOFENADINE HYDROCHLORIDE TABLET FEXOFENADINE HYDROCHLORIDE Discontinued AB
076502-002 FEXOFENADINE HYDROCHLORIDE TABLET FEXOFENADINE HYDROCHLORIDE Discontinued AB
076502-003 FEXOFENADINE HYDROCHLORIDE TABLET FEXOFENADINE HYDROCHLORIDE Discontinued AB
076502-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY TABLET FEXOFENADINE HYDROCHLORIDE Over-the-counter —
076502-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES TABLET FEXOFENADINE HYDROCHLORIDE Over-the-counter —
076502-006 FEXOFENADINE HYDROCHLORIDE ALLERGY TABLET FEXOFENADINE HYDROCHLORIDE Over-the-counter —
076502-007 FEXOFENADINE HYDROCHLORIDE HIVES TABLET FEXOFENADINE HYDROCHLORIDE Over-the-counter —
076502-008 FEXOFENADINE HYDROCHLORIDE ALLERGY TABLET FEXOFENADINE HYDROCHLORIDE Over-the-counter —
076502-009 FEXOFENADINE HYDROCHLORIDE HIVES TABLET FEXOFENADINE HYDROCHLORIDE Over-the-counter —

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
No
Reference Standard
No

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

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

Approval history

Source: Drugs@FDA
Most recent submissions on application 076502.
Type No. Action Status Date Review
Supplement 9 Manufacturing (CMC) Approved January 2, 2013 —
Supplement 8 Manufacturing (CMC) Approved September 23, 2011 —
Supplement 7 Manufacturing (CMC) Approved April 12, 2011 —
Supplement 2 Labeling Approved January 14, 2009 —
Original application 1 Approved April 11, 2006 —

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260709). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260709 HUMAN OTC DRUG · 20140122

Indications and Usage

openFDA Drug Labeling

Use(s) Allergy temporarily relieves these symptoms due to hay fever or otherupper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat Hives reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occuring.

Purpose

openFDA Drug Labeling

Purpose Antihistamine

Dosage and Administration

openFDA Drug Labeling

Directions 30 mg adults and children 12 yearsof age and over take two 30 mg tablets with water every 12 hours; do not take more than 4 tablets in 24 hours children 6 to under 12 years of age take one 30 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours children under 6 years of age do not use Adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor 60 mg: adults and children 12 years of age and over take one 60 mg tablet with water every 12 hours; do not take morethan 2 tablets in 24 hours children under 12 years of age do not use Adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor 180 mg: adults and children 12 years of age and over take one 180 mg tablet with water once a day; do not take more than1 tablet in 24 hours children under 12 years of age do not use Adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor

Warnings

openFDA Drug Labeling

Warnings Hives Severe Allergic Warning: Get emergency help immediately if you have hives along with any of the following symptom: trouble swallowing dizziness or loss of consciousness swelling of tongue swelling in or around mouth trouble speaking drooling wheezing or problems breathing These symptoms may be signs of anaphylactic shock. This condition canbe life threatening if not treated by a health professional immediately .Symptoms of anaphylactic shock may occur when hives first appear or upto a few hours later. Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrineinjector for “anaphylaxis” or severe allergy symptoms that could occur withyour hives, never use this product as a substitute for the epinephrine injector.If you have been prescribed an epinephrine injector, you should carry it withyou at all times. Do not use Allergy if you have ever had an allergic reaction to this product or any of its ingredients. Hives to prevent hives from any known cause such as: foods insect stings medicines latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have Allergy kidney disease. Your doctorshould determine if you need a different dose. Hives kidney disease. Your doctor should determine if you need a different dose. hives that are an unusual color, look bruised or blistered hives that do not itch When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions) Stop use and ask doctor if Allergy an allergic reaction to this product occurs. Seek medical help right away. Hives an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve after 3 days of treatment the hives have lasted more than 6 weeks 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.

Do Not Use

openFDA Drug Labeling

Do not use Allergy if you have ever had an allergic reaction to this product or any of its ingredients. Hives to prevent hives from any known cause such as: foods insect stings medicines latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause. if you have ever had an allergic reaction to this product or any of its ingredients

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have Allergy kidney disease. Your doctorshould determine if you need a different dose. Hives kidney disease. Your doctor should determine if you need a different dose. hives that are an unusual color, look bruised or blistered hives that do not itch

Stop Use

openFDA Drug Labeling

Stop use and ask doctor if Allergy an allergic reaction to this product occurs. Seek medical help right away. Hives an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve after 3 days of treatment the hives have lasted more than 6 weeks

Active Ingredient

openFDA Drug Labeling

Active ingredient(s) Fexofenadine HCl USP, 30 mg Fexofenadine HCl USP, 60 mg Fexofenadine HCl USP, 180 mg

Adverse event reports

Source: openFDA FAERS
21,660
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: FEXOFENADINE HYDROCHLORIDE. 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
68001-439-00 68001-439 BluePoint Laboratories 1 BOTTLE in 1 CARTON (68001-439-00) / 100 TABLET in 1 BOTTLE June 19, 2020
68001-440-00 68001-440 BluePoint Laboratories 1 BOTTLE in 1 CARTON (68001-440-00) / 100 TABLET in 1 BOTTLE June 19, 2020
68001-440-04 68001-440 BluePoint Laboratories 1 BOTTLE in 1 CARTON (68001-440-04) / 30 TABLET in 1 BOTTLE June 19, 2020
69842-052-15 69842-052 CVS Health Corp. 3 BLISTER PACK in 1 CARTON (69842-052-15) / 5 TABLET in 1 BLISTER PACK April 1, 2011
69842-052-18 69842-052 CVS Health Corp. 1 CARTON in 1 CARTON (69842-052-18) / 180 TABLET in 1 CARTON February 1, 2013
69842-052-29 69842-052 CVS Health Corp. 3 BLISTER PACK in 1 CARTON (69842-052-29) / 15 TABLET in 1 BLISTER PACK April 1, 2011
69842-052-30 69842-052 CVS Health Corp. 1 BOTTLE in 1 CARTON (69842-052-30) / 30 TABLET in 1 BOTTLE April 1, 2011
69842-052-45 69842-052 CVS Health Corp. 1 BOTTLE in 1 CARTON (69842-052-45) / 45 TABLET in 1 BOTTLE April 1, 2011
69842-052-70 69842-052 CVS Health Corp. 1 BOTTLE in 1 CARTON (69842-052-70) / 70 TABLET in 1 BOTTLE January 11, 2019
69842-052-90 69842-052 CVS Health Corp. 1 BOTTLE in 1 CARTON (69842-052-90) / 90 TABLET in 1 BOTTLE April 1, 2011
51316-800-08 51316-800 CVS PHARMACY, INC 1 BOTTLE in 1 CARTON (51316-800-08) / 180 TABLET in 1 BOTTLE September 20, 2022
51316-800-15 51316-800 CVS PHARMACY, INC 1 BLISTER PACK in 1 CARTON (51316-800-15) / 15 TABLET in 1 BLISTER PACK September 20, 2022
51316-800-30 51316-800 CVS PHARMACY, INC 1 BOTTLE in 1 CARTON (51316-800-30) / 30 TABLET in 1 BOTTLE September 20, 2022
51316-800-45 51316-800 CVS PHARMACY, INC 1 BOTTLE in 1 CARTON (51316-800-45) / 45 TABLET in 1 BOTTLE September 20, 2022
51316-800-70 51316-800 CVS PHARMACY, INC 1 BOTTLE in 1 CARTON (51316-800-70) / 70 TABLET in 1 BOTTLE September 20, 2022
51316-800-90 51316-800 CVS PHARMACY, INC 1 BOTTLE in 1 CARTON (51316-800-90) / 90 TABLET in 1 BOTTLE September 20, 2022
82725-0102-2 82725-0102 Cabinet Health P.B.C. 1 BAG in 1 DRUM (82725-0102-2) / 40000 TABLET in 1 BAG October 25, 2025
82725-0102-3 82725-0102 Cabinet Health P.B.C. 5000 TABLET in 1 BAG (82725-0102-3) October 25, 2025
68016-995-03 68016-995 Chain Drug Consortium, LLC 1 BOTTLE in 1 CARTON (68016-995-03) / 30 TABLET in 1 BOTTLE April 1, 2014
68016-995-45 68016-995 Chain Drug Consortium, LLC 1 BOTTLE in 1 CARTON (68016-995-45) / 45 TABLET in 1 BOTTLE April 1, 2014
63868-025-30 63868-025 Chain Drug Marketing Associate 1 BOTTLE in 1 CARTON (63868-025-30) / 30 TABLET in 1 BOTTLE April 1, 2014
55910-111-30 55910-111 Dollar General 1 BOTTLE in 1 CARTON (55910-111-30) / 30 TABLET in 1 BOTTLE July 17, 2019
43598-577-89 43598-577 Dr. Reddy's Laboratories Inc. 1500 TABLET in 1 POUCH (43598-577-89) July 25, 2016
43598-809-18 43598-809 Dr. Reddy's Laboratories Inc. 1 BOTTLE in 1 CARTON (43598-809-18) / 180 TABLET in 1 BOTTLE December 26, 2018
43598-809-90 43598-809 Dr. Reddy's Laboratories Inc. 1 BOTTLE in 1 CARTON (43598-809-90) / 90 TABLET in 1 BOTTLE December 26, 2018
43598-936-01 43598-936 Dr. Reddy's Laboratories Inc. 1 BOTTLE in 1 CARTON (43598-936-01) / 100 TABLET in 1 BOTTLE December 1, 2020
55111-782-01 55111-782 Dr. Reddy's Laboratories Limited 100 TABLET in 1 BOTTLE (55111-782-01) January 3, 2011
55111-782-30 55111-782 Dr. Reddy's Laboratories Limited 30 TABLET in 1 BOTTLE (55111-782-30) January 3, 2011
55111-782-78 55111-782 Dr. Reddy's Laboratories Limited 10 BLISTER PACK in 1 CARTON (55111-782-78) / 10 TABLET in 1 BLISTER PACK (55111-782-79) January 3, 2011
55111-782-90 55111-782 Dr. Reddy's Laboratories Limited 90 TABLET in 1 BOTTLE (55111-782-90) January 3, 2011
55111-783-01 55111-783 Dr. Reddy's Laboratories Limited 100 TABLET in 1 BOTTLE (55111-783-01) January 3, 2011
55111-783-24 55111-783 Dr. Reddy's Laboratories Limited 4 BLISTER PACK in 1 CARTON (55111-783-24) / 6 TABLET in 1 BLISTER PACK December 1, 2020
55111-783-28 55111-783 Dr. Reddy's Laboratories Limited 2 BLISTER PACK in 1 CARTON (55111-783-28) / 6 TABLET in 1 BLISTER PACK December 1, 2020
55111-783-60 55111-783 Dr. Reddy's Laboratories Limited 60 TABLET in 1 BOTTLE (55111-783-60) January 3, 2011
55111-783-78 55111-783 Dr. Reddy's Laboratories Limited 10 BLISTER PACK in 1 CARTON (55111-783-78) / 10 TABLET in 1 BLISTER PACK (55111-783-79) January 3, 2011
55111-783-90 55111-783 Dr. Reddy's Laboratories Limited 90 TABLET in 1 BOTTLE (55111-783-90) January 3, 2011
55111-783-94 55111-783 Dr. Reddy's Laboratories Limited 4000 TABLET in 1 POUCH (55111-783-94) October 14, 2020
55111-784-01 55111-784 Dr. Reddy's Laboratories Limited 1 BOTTLE in 1 CARTON (55111-784-01) / 100 TABLET in 1 BOTTLE January 3, 2011
55111-784-05 55111-784 Dr. Reddy's Laboratories Limited 1 BOTTLE in 1 CARTON (55111-784-05) / 500 TABLET in 1 BOTTLE January 3, 2011
55111-784-07 55111-784 Dr. Reddy's Laboratories Limited 1 BLISTER PACK in 1 CARTON (55111-784-07) / 5 TABLET in 1 BLISTER PACK January 3, 2011
55111-784-15 55111-784 Dr. Reddy's Laboratories Limited 1 BOTTLE in 1 CARTON (55111-784-15) / 150 TABLET in 1 BOTTLE January 3, 2011
55111-784-18 55111-784 Dr. Reddy's Laboratories Limited 1 BOTTLE in 1 CARTON (55111-784-18) / 180 TABLET in 1 BOTTLE January 3, 2011
55111-784-23 55111-784 Dr. Reddy's Laboratories Limited 1 BLISTER PACK in 1 CARTON (55111-784-23) / 2 TABLET in 1 BLISTER PACK January 3, 2011
55111-784-28 55111-784 Dr. Reddy's Laboratories Limited 3 BLISTER PACK in 1 CARTON (55111-784-28) / 15 TABLET in 1 BLISTER PACK January 3, 2011
55111-784-29 55111-784 Dr. Reddy's Laboratories Limited 3 BLISTER PACK in 1 CARTON (55111-784-29) / 5 TABLET in 1 BLISTER PACK January 3, 2011
55111-784-30 55111-784 Dr. Reddy's Laboratories Limited 1 BOTTLE in 1 CARTON (55111-784-30) / 30 TABLET in 1 BOTTLE January 3, 2011
55111-784-35 55111-784 Dr. Reddy's Laboratories Limited 2 BLISTER PACK in 1 CARTON (55111-784-35) / 5 TABLET in 1 BLISTER PACK December 1, 2021
55111-784-40 55111-784 Dr. Reddy's Laboratories Limited 1 BOTTLE in 1 CARTON (55111-784-40) / 40 TABLET in 1 BOTTLE January 3, 2011
55111-784-43 55111-784 Dr. Reddy's Laboratories Limited 2 BOTTLE in 1 CARTON (55111-784-43) / 30 TABLET in 1 BOTTLE January 3, 2011
55111-784-45 55111-784 Dr. Reddy's Laboratories Limited 1 BOTTLE in 1 CARTON (55111-784-45) / 45 TABLET in 1 BOTTLE January 3, 2011
55111-784-59 55111-784 Dr. Reddy's Laboratories Limited 2 BOTTLE in 1 CARTON (55111-784-59) / 60 TABLET in 1 BOTTLE January 3, 2011
55111-784-75 55111-784 Dr. Reddy's Laboratories Limited 1 BOTTLE in 1 CARTON (55111-784-75) / 70 TABLET in 1 BOTTLE January 3, 2011
55111-784-78 55111-784 Dr. Reddy's Laboratories Limited 10 BLISTER PACK in 1 CARTON (55111-784-78) / 10 TABLET in 1 BLISTER PACK (55111-784-79) January 3, 2011
55111-784-89 55111-784 Dr. Reddy's Laboratories Limited 1500 TABLET in 1 POUCH (55111-784-89) February 17, 2016
55111-784-90 55111-784 Dr. Reddy's Laboratories Limited 1 BOTTLE in 1 CARTON (55111-784-90) / 90 TABLET in 1 BOTTLE January 3, 2011
62207-623-41 62207-623 Granules India Limited 24 TABLET in 1 CONTAINER (62207-623-41) January 2, 2024
62207-623-45 62207-623 Granules India Limited 225 TABLET in 1 CONTAINER (62207-623-45) January 2, 2024
62207-623-57 62207-623 Granules India Limited 90 TABLET in 1 CONTAINER (62207-623-57) January 2, 2024
62207-623-71 62207-623 Granules India Limited 7 BLISTER PACK in 1 CARTON (62207-623-71) / 10 TABLET in 1 BLISTER PACK January 2, 2024
62207-623-97 62207-623 Granules India Limited 40000 TABLET in 1 DRUM (62207-623-97) November 27, 2023
62207-765-49 62207-765 Granules India Ltd 1000 TABLET in 1 BOTTLE (62207-765-49) December 18, 2020
62207-765-51 62207-765 Granules India Ltd 1 BOTTLE in 1 CARTON (62207-765-51) / 10 TABLET in 1 BOTTLE December 18, 2020
62207-765-60 62207-765 Granules India Ltd 8 BLISTER PACK in 1 CARTON (62207-765-60) / 9 TABLET in 1 BLISTER PACK December 18, 2020
62207-765-88 62207-765 Granules India Ltd 5 POUCH in 1 BOX (62207-765-88) / 10000 TABLET in 1 POUCH November 17, 2021
62207-766-35 62207-766 Granules India Ltd 25000 TABLET in 1 BOX (62207-766-35) December 18, 2020
62207-766-49 62207-766 Granules India Ltd 1000 TABLET in 1 BOTTLE (62207-766-49) December 18, 2020
62207-766-51 62207-766 Granules India Ltd 1 BOTTLE in 1 CARTON (62207-766-51) / 10 TABLET in 1 BOTTLE December 18, 2020
62207-766-58 62207-766 Granules India Ltd 7 BLISTER PACK in 1 CARTON (62207-766-58) / 10 TABLET in 1 BLISTER PACK December 18, 2020
30142-878-15 30142-878 KROGER COMPANY 3 BLISTER PACK in 1 CARTON (30142-878-15) / 5 TABLET in 1 BLISTER PACK September 30, 2018
30142-878-30 30142-878 KROGER COMPANY 1 BOTTLE in 1 CARTON (30142-878-30) / 30 TABLET in 1 BOTTLE September 30, 2018
30142-878-64 30142-878 KROGER COMPANY 2 BOTTLE in 1 CARTON (30142-878-64) / 70 TABLET in 1 BOTTLE January 10, 2019
30142-878-70 30142-878 KROGER COMPANY 1 BOTTLE in 1 CARTON (30142-878-70) / 70 TABLET in 1 BOTTLE September 30, 2018
0904-7050-40 0904-7050 Major Pharmaceuticals 500 TABLET in 1 BOTTLE, PLASTIC (0904-7050-40) November 29, 2019
0904-7050-60 0904-7050 Major Pharmaceuticals 100 TABLET in 1 BOTTLE, PLASTIC (0904-7050-60) November 29, 2019
84324-008-01 84324-008 NUVICARE LLC 18 TABLET in 1 BOTTLE (84324-008-01) July 17, 2024
84324-008-02 84324-008 NUVICARE LLC 4 TABLET in 1 BLISTER PACK (84324-008-02) June 9, 2025
84324-045-01 84324-045 NUVICARE LLC 60 TABLET in 1 BOTTLE (84324-045-01) July 30, 2026
51655-231-26 51655-231 Northwind Health Company, LLC 90 TABLET in 1 BOTTLE, PLASTIC (51655-231-26) December 8, 2022
51655-231-52 51655-231 Northwind Health Company, LLC 30 TABLET in 1 BOTTLE, PLASTIC (51655-231-52) November 16, 2022
72091-010-00 72091-010 PLS ANALYTICAL 40000 TABLET in 1 BAG (72091-010-00) May 1, 2026
72091-010-01 72091-010 PLS ANALYTICAL 5000 TABLET in 1 BAG (72091-010-01) May 1, 2026
72090-010-01 72090-010 Pioneer Life Sciences, LLC 90 TABLET in 1 BOTTLE (72090-010-01) December 7, 2023
72090-010-02 72090-010 Pioneer Life Sciences, LLC 100 TABLET in 1 BOTTLE (72090-010-02) October 29, 2024
72090-010-03 72090-010 Pioneer Life Sciences, LLC 50 TABLET in 1 BOTTLE (72090-010-03) October 3, 2024
72090-010-04 72090-010 Pioneer Life Sciences, LLC 150 TABLET in 1 BOTTLE (72090-010-04) October 3, 2024
72090-010-99 72090-010 Pioneer Life Sciences, LLC 1000 TABLET in 1 BOTTLE (72090-010-99) August 11, 2023
71309-091-01 71309-091 Safrel Pharmaceuticals, LLC. 100 TABLET in 1 BOTTLE (71309-091-01) January 31, 2021
68196-107-15 68196-107 Sam's West Inc. 1 BOTTLE in 1 CARTON (68196-107-15) / 150 TABLET in 1 BOTTLE May 9, 2017
68196-107-50 68196-107 Sam's West Inc. 150 TABLET in 1 BOTTLE (68196-107-50) April 1, 2023
70677-1009-1 70677-1009 Strategic Sourcing Services, LLC 3 BLISTER PACK in 1 CARTON (70677-1009-1) / 5 TABLET in 1 BLISTER PACK May 5, 2023
70677-1009-2 70677-1009 Strategic Sourcing Services, LLC 1 BOTTLE in 1 CARTON (70677-1009-2) / 30 TABLET in 1 BOTTLE May 5, 2023
70677-1009-3 70677-1009 Strategic Sourcing Services, LLC 1 BOTTLE in 1 CARTON (70677-1009-3) / 70 TABLET in 1 BOTTLE May 5, 2023
0363-0783-24 0363-0783 Walgreens Company 4 BLISTER PACK in 1 CARTON (0363-0783-24) / 6 TABLET in 1 BLISTER PACK December 14, 2020
73581-025-01 73581-025 YYBA Corp 10 TABLET in 1 BOTTLE (73581-025-01) December 18, 2025
73581-025-06 73581-025 YYBA Corp 60 TABLET in 1 BOTTLE (73581-025-06) December 18, 2025
73581-025-20 73581-025 YYBA Corp 200 TABLET in 1 BOTTLE (73581-025-20) December 18, 2025
73581-026-01 73581-026 YYBA Corp 10 TABLET in 1 BOTTLE (73581-026-01) December 18, 2025
73581-026-10 73581-026 YYBA Corp 100 TABLET in 1 BOTTLE (73581-026-10) December 18, 2025
73581-026-20 73581-026 YYBA Corp 200 TABLET in 1 BOTTLE (73581-026-20) December 18, 2025
73581-027-01 73581-027 YYBA Corp 10 TABLET in 1 BOTTLE (73581-027-01) October 3, 2025
73581-027-04 73581-027 YYBA Corp 40 TABLET in 1 BOTTLE (73581-027-04) October 3, 2024
73581-027-10 73581-027 YYBA Corp 100 TABLET in 1 BOTTLE (73581-027-10) October 3, 2025
73581-027-20 73581-027 YYBA Corp 200 TABLET in 1 BOTTLE (73581-027-20) October 29, 2025
68001-439 68001-439 BluePoint Laboratories — June 19, 2020
68001-440 68001-440 BluePoint Laboratories — June 19, 2020
69842-052 69842-052 CVS Health Corp. — April 1, 2011
51316-800 51316-800 CVS PHARMACY, INC — September 20, 2022
82725-0102 82725-0102 Cabinet Health P.B.C. — October 25, 2025
68016-995 68016-995 Chain Drug Consortium, LLC — April 1, 2014
63868-025 63868-025 Chain Drug Marketing Associate — April 1, 2014
55910-111 55910-111 Dollar General — July 17, 2019
43598-577 43598-577 Dr. Reddy's Laboratories Inc. — July 25, 2016
43598-809 43598-809 Dr. Reddy's Laboratories Inc. — December 26, 2018
43598-936 43598-936 Dr. Reddy's Laboratories Inc. — December 1, 2020
55111-782 55111-782 Dr. Reddy's Laboratories Limited — January 3, 2011
55111-783 55111-783 Dr. Reddy's Laboratories Limited — January 3, 2011
55111-784 55111-784 Dr. Reddy's Laboratories Limited — February 17, 2016
62207-623 62207-623 Granules India Limited — January 2, 2024
62207-765 62207-765 Granules India Ltd — December 18, 2020
62207-766 62207-766 Granules India Ltd — December 18, 2020
30142-878 30142-878 KROGER COMPANY — September 30, 2018
0904-7050 0904-7050 Major Pharmaceuticals — November 29, 2019
84324-008 84324-008 NUVICARE LLC — June 9, 2025
84324-045 84324-045 NUVICARE LLC — July 30, 2026
51655-231 51655-231 Northwind Health Company, LLC — November 16, 2022
72091-010 72091-010 PLS ANALYTICAL — May 1, 2026
72090-010 72090-010 Pioneer Life Sciences, LLC — August 11, 2023
71309-091 71309-091 Safrel Pharmaceuticals, LLC. — January 3, 2021
68196-107 68196-107 Sam's West Inc. — May 9, 2017
70677-1009 70677-1009 Strategic Sourcing Services, LLC — September 9, 2019
0363-0783 0363-0783 Walgreens Company — December 14, 2020
73581-025 73581-025 YYBA Corp — December 18, 2025
73581-026 73581-026 YYBA Corp — December 18, 2025
73581-027 73581-027 YYBA Corp — October 1, 2024

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 · 12 sections on this page.