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Cetirizine Hydrochloride
Over-the-counter ANDA 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
Cetirizine Hydrochloride
Generic name
Cetirizine Hydrochloride
Dosage form
Tablet
Route
—
Marketing category
ANDA · ANDA
Labeler
Aurobindo Pharma Limited
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
52
Packages
129
Data completeness
83%
of corroborating sources present
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryDosage form
Tablet
Route of administration
—
Presentations
181
Pharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| 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 DirectoryApplication number
077498
Application type
ANDA · Abbreviated New Drug Application
Approval date
December 27, 2007
Sponsor
SUN PHARM INDS LTD
Products on application
4
Submissions recorded
2
| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 077498-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | TABLET | CETIRIZINE HYDROCHLORIDE | Over-the-counter | — | ||
| 077498-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | TABLET | CETIRIZINE HYDROCHLORIDE | Over-the-counter | — | ||
| 077498-003 | CETIRIZINE HYDROCHLORIDE HIVES | TABLET | CETIRIZINE HYDROCHLORIDE | Over-the-counter | — | ||
| 077498-004 | CETIRIZINE HYDROCHLORIDE HIVES | TABLET | CETIRIZINE HYDROCHLORIDE | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 5 | Labeling | Approved | February 15, 2011 | — |
| Original application | 1 | Approved | December 27, 2007 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260820). This is the manufacturer's labelling text, not a summary and not advice.
HUMAN OTC DRUG · 20260820 HUMAN OTC DRUG · 20260603 HUMAN OTC DRUG · 20241023 HUMAN OTC DRUG · 20240731
Indications and Usage
openFDA Drug LabelingINDICATIONS AND USAGE temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ● runny nose ● sneezing ● itchy, watery eyes ● itching of the nose or throat
Purpose
openFDA Drug LabelingUses Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies runny nose sneezing itchy, watery eyes itching of the nose or throat
Dosage and Administration
openFDA Drug LabelingDIRECTIONS Adults and children 6 years and over 1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10 mg) in 24 hours. Adults 65 years and over 1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours. Children under 6 years of age ask a doctor Consumers with liver or kidney disease ask a doctor
Warnings
openFDA Drug LabelingWARNINGS: DO NOT USE Do Not Use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. ASK DOCTOR Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. ASK DOCTOR/PHARMACIST Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. WHEN USING THIS PRODUCT • drowsines may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinary. STOP USE Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. IF PREGNANT OR BREAST-FEEDING • if breast-feeding: not recommended • if pregnant: ask a health professional before use. KEEP OUT OF REACH OF CHILDREN In case of overdose, get medical help or contact Poison Control Center right away. (1-800-222-1222)
Do Not Use
openFDA Drug LabelingDO NOT USE Do not use • 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 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 its ingredients or to an antihistamine containing hydroxyzine.
Ask a Doctor
openFDA Drug LabelingASK DOCTOR Ask a doctor before use if you have • liver or 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 LabelingSTOP USE Stop use and ask a doctor if • 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
Description
openFDA Drug LabelingQUESTIONS 1-855-221-5332: Weekdays 9AM - 5PM EST
Active Ingredient
openFDA Drug LabelingActive Ingredients Active Ingredients (in each tablet) Purpose Cetirizine HCl 10 mg..............................................................................................Antihistimine
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED NDC: 71335-0300-1: 30 Tablets in a BOTTLE NDC: 71335-0300-2: 14 Tablets in a BOTTLE NDC: 71335-0300-3: 7 Tablets in a BOTTLE NDC: 71335-0300-4: 10 Tablets in a BOTTLE NDC: 71335-0300-5: 15 Tablets in a BOTTLE NDC: 71335-0300-6: 90 Tablets in a BOTTLE NDC: 71335-0300-7: 20 Tablets in a BOTTLE NDC: 71335-0300-8: 60 Tablets in a BOTTLE NDC: 71335-0300-9: 100 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
Adverse event reports
Source: openFDA FAERS166,303
FAERS reports mentioning this drug
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: CETIRIZINE 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.
Recalls
Source: FDA Enforcement| Classification | Reported | Firm | Reason | Status |
|---|---|---|---|---|
| Class I | July 29, 2026 | JB Chemicals and Pharmaceuticals Ltd | Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine. | Ongoing |
| Class III | October 29, 2025 | JB Chemicals and Pharmaceuticals Ltd | Tablet/Capsules Imprinted with Wrong ID | Ongoing |
| Class III | October 29, 2025 | JB Chemicals and Pharmaceuticals Ltd | Tablet/Capsules Imprinted with Wrong ID | Ongoing |
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 52493-046-89 | 52493-046 | Amneal Pharmaceuticals Co. (I) Pvt. Ltd. | 10 kg in 1 DRUM (52493-046-89) | July 20, 2022 |
| 65162-045-03 | 65162-045 | Amneal Pharmaceuticals LLC | 1 BOTTLE in 1 CARTON (65162-045-03) / 30 TABLET in 1 BOTTLE | January 21, 2010 |
| 65162-045-50 | 65162-045 | Amneal Pharmaceuticals LLC | 500 TABLET in 1 BOTTLE (65162-045-50) | January 21, 2010 |
| 65162-046-03 | 65162-046 | Amneal Pharmaceuticals LLC | 1 BOTTLE in 1 CARTON (65162-046-03) / 30 TABLET in 1 BOTTLE | January 21, 2010 |
| 65162-046-50 | 65162-046 | Amneal Pharmaceuticals LLC | 500 TABLET in 1 BOTTLE (65162-046-50) | January 21, 2010 |
| 65162-145-03 | 65162-145 | Amneal Pharmaceuticals LLC | 1 BOTTLE in 1 CARTON (65162-145-03) / 30 TABLET in 1 BOTTLE | January 21, 2010 |
| 65162-145-50 | 65162-145 | Amneal Pharmaceuticals LLC | 500 TABLET in 1 BOTTLE (65162-145-50) | January 21, 2010 |
| 71610-821-30 | 71610-821 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET in 1 BOTTLE (71610-821-30) | April 12, 2024 |
| 71610-821-60 | 71610-821 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (71610-821-60) | April 12, 2024 |
| 71610-862-30 | 71610-862 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET in 1 BOTTLE (71610-862-30) | October 28, 2024 |
| 71610-862-60 | 71610-862 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (71610-862-60) | October 28, 2024 |
| 59651-097-62 | 59651-097 | Aurobindo Pharma Limited | 3000 TABLET in 1 BAG (59651-097-62) | February 28, 2017 |
| 59651-098-62 | 59651-098 | Aurobindo Pharma Limited | 3000 TABLET in 1 BAG (59651-098-62) | February 28, 2017 |
| 65862-444-59 | 65862-444 | Aurobindo Pharma Limited | 5000 TABLET in 1 BAG (65862-444-59) | August 5, 2015 |
| 65862-445-39 | 65862-445 | Aurobindo Pharma Limited | 3000 TABLET in 1 BAG (65862-445-39) | August 5, 2015 |
| 65862-446-59 | 65862-446 | Aurobindo Pharma Limited | 5000 TABLET in 1 BAG (65862-446-59) | August 5, 2015 |
| 65862-447-39 | 65862-447 | Aurobindo Pharma Limited | 3000 TABLET in 1 BAG (65862-447-39) | August 5, 2015 |
| 37835-611-14 | 37835-611 | Bi-Mar | 14 TABLET in 1 BOTTLE (37835-611-14) | May 1, 2025 |
| 37835-611-35 | 37835-611 | Bi-Mar | 35 TABLET in 1 BOTTLE (37835-611-35) | May 1, 2025 |
| 37835-611-90 | 37835-611 | Bi-Mar | 90 TABLET in 1 BOTTLE (37835-611-90) | May 1, 2025 |
| 63629-4914-1 | 63629-4914 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (63629-4914-1) | February 19, 2013 |
| 71335-0300-1 | 71335-0300 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-0300-1) | February 16, 2018 |
| 71335-0300-2 | 71335-0300 | Bryant Ranch Prepack | 14 TABLET in 1 BOTTLE (71335-0300-2) | February 20, 2018 |
| 71335-0300-3 | 71335-0300 | Bryant Ranch Prepack | 7 TABLET in 1 BOTTLE (71335-0300-3) | February 9, 2022 |
| 71335-0300-4 | 71335-0300 | Bryant Ranch Prepack | 10 TABLET in 1 BOTTLE (71335-0300-4) | March 19, 2019 |
| 71335-0300-5 | 71335-0300 | Bryant Ranch Prepack | 15 TABLET in 1 BOTTLE (71335-0300-5) | February 9, 2022 |
| 71335-0300-6 | 71335-0300 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-0300-6) | February 16, 2018 |
| 71335-0300-7 | 71335-0300 | Bryant Ranch Prepack | 20 TABLET in 1 BOTTLE (71335-0300-7) | March 7, 2019 |
| 71335-0300-8 | 71335-0300 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-0300-8) | October 13, 2021 |
| 71335-0300-9 | 71335-0300 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-0300-9) | May 3, 2019 |
| 82725-0103-1 | 82725-0103 | Cabinet Health P.B.C. | 10 BAG in 1 DRUM (82725-0103-1) / 10000 TABLET in 1 BAG | April 21, 2025 |
| 82725-0103-2 | 82725-0103 | Cabinet Health P.B.C. | 10000 TABLET in 1 BAG (82725-0103-2) | April 21, 2025 |
| 68016-939-30 | 68016-939 | Chain Drug Consortium, LLC | 30 TABLET in 1 BOTTLE (68016-939-30) | December 27, 2007 |
| 68016-939-54 | 68016-939 | Chain Drug Consortium, LLC | 14 TABLET in 1 BLISTER PACK (68016-939-54) | December 27, 2007 |
| 68016-939-60 | 68016-939 | Chain Drug Consortium, LLC | 60 TABLET in 1 BOTTLE (68016-939-60) | December 27, 2007 |
| 68016-939-90 | 68016-939 | Chain Drug Consortium, LLC | 90 TABLET in 1 BOTTLE (68016-939-90) | December 27, 2007 |
| 55319-939-30 | 55319-939 | FAMILY DOLLAR SERVICES, INC | 30 TABLET in 1 BOTTLE (55319-939-30) | September 1, 2017 |
| 55319-939-54 | 55319-939 | FAMILY DOLLAR SERVICES, INC | 14 TABLET in 1 BLISTER PACK (55319-939-54) | September 1, 2017 |
| 81469-353-01 | 81469-353 | First Nation Group, LLC | 100 TABLET in 1 BOTTLE (81469-353-01) | June 1, 2026 |
| 81469-353-03 | 81469-353 | First Nation Group, LLC | 300 TABLET in 1 BOTTLE (81469-353-03) | June 1, 2026 |
| 81469-353-05 | 81469-353 | First Nation Group, LLC | 500 TABLET in 1 BOTTLE (81469-353-05) | June 1, 2026 |
| 81469-353-90 | 81469-353 | First Nation Group, LLC | 90 TABLET in 1 BOTTLE (81469-353-90) | June 1, 2026 |
| 69848-006-09 | 69848-006 | Granules USA, Inc. | 90 TABLET in 1 BOTTLE (69848-006-09) | June 30, 2021 |
| 70000-0047-1 | 70000-0047 | LEADER/ CARDINAL HEALTH 110, INC. | 365 TABLET in 1 BOTTLE (70000-0047-1) | March 26, 2020 |
| 71141-133-32 | 71141-133 | LIDL US, LLC | 1 BLISTER PACK in 1 CARTON (71141-133-32) / 14 TABLET in 1 BLISTER PACK | September 1, 2017 |
| 68998-939-30 | 68998-939 | Marc Glassman, Inc. | 30 TABLET in 1 BOTTLE (68998-939-30) | November 1, 2012 |
| 10135-762-01 | 10135-762 | Marlex Pharmaceuticals, Inc | 100 TABLET in 1 BOTTLE (10135-762-01) | October 1, 2022 |
| 10135-762-03 | 10135-762 | Marlex Pharmaceuticals, Inc | 300 TABLET in 1 BOTTLE (10135-762-03) | October 1, 2022 |
| 10135-762-05 | 10135-762 | Marlex Pharmaceuticals, Inc | 500 TABLET in 1 BOTTLE (10135-762-05) | October 1, 2022 |
| 10135-762-30 | 10135-762 | Marlex Pharmaceuticals, Inc | 30 TABLET in 1 BOTTLE (10135-762-30) | October 1, 2022 |
| 10135-762-90 | 10135-762 | Marlex Pharmaceuticals, Inc | 90 TABLET in 1 BOTTLE (10135-762-90) | October 1, 2022 |
| 68071-1964-1 | 68071-1964 | NuCare Pharmaceuticals, Inc. | 10 TABLET in 1 BOTTLE (68071-1964-1) | February 21, 2017 |
| 68071-1964-3 | 68071-1964 | NuCare Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE (68071-1964-3) | February 21, 2017 |
| 68071-1964-4 | 68071-1964 | NuCare Pharmaceuticals, Inc. | 14 TABLET in 1 BOTTLE (68071-1964-4) | February 21, 2017 |
| 68071-1964-7 | 68071-1964 | NuCare Pharmaceuticals, Inc. | 7 TABLET in 1 BOTTLE (68071-1964-7) | February 21, 2017 |
| 68071-1964-9 | 68071-1964 | NuCare Pharmaceuticals, Inc. | 90 TABLET in 1 BOTTLE (68071-1964-9) | February 21, 2017 |
| 68071-2571-7 | 68071-2571 | NuCare Pharmaceuticals,Inc. | 7 TABLET in 1 BOTTLE (68071-2571-7) | November 15, 2021 |
| 69729-139-14 | 69729-139 | OPMX LLC | 14 TABLET in 1 BOTTLE (69729-139-14) | July 1, 2020 |
| 51660-939-04 | 51660-939 | Ohm Laboratories Inc | 5000 TABLET in 1 BAG (51660-939-04) | November 28, 2024 |
| 51660-939-01 | 51660-939 | Ohm Laboratories Inc. | 100 TABLET in 1 BOTTLE (51660-939-01) | December 27, 2007 |
| 51660-939-13 | 51660-939 | Ohm Laboratories Inc. | 120 TABLET in 1 BOTTLE (51660-939-13) | December 27, 2007 |
| 51660-939-30 | 51660-939 | Ohm Laboratories Inc. | 30 TABLET in 1 BOTTLE (51660-939-30) | December 27, 2007 |
| 51660-939-53 | 51660-939 | Ohm Laboratories Inc. | 300 TABLET in 1 BOTTLE (51660-939-53) | December 27, 2007 |
| 51660-939-54 | 51660-939 | Ohm Laboratories Inc. | 14 TABLET in 1 BLISTER PACK (51660-939-54) | December 27, 2007 |
| 51660-939-90 | 51660-939 | Ohm Laboratories Inc. | 90 TABLET in 1 BOTTLE (51660-939-90) | December 27, 2007 |
| 55289-995-07 | 55289-995 | PD-Rx Pharmaceuticals, Inc. | 7 TABLET in 1 BOTTLE, PLASTIC (55289-995-07) | March 8, 2022 |
| 55289-995-10 | 55289-995 | PD-Rx Pharmaceuticals, Inc. | 10 TABLET in 1 BOTTLE, PLASTIC (55289-995-10) | August 9, 2022 |
| 55289-995-30 | 55289-995 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE, PLASTIC (55289-995-30) | April 26, 2018 |
| 72789-343-10 | 72789-343 | PD-Rx Pharmaceuticals, Inc. | 10 TABLET in 1 BOTTLE, PLASTIC (72789-343-10) | March 27, 2024 |
| 72789-343-30 | 72789-343 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE, PLASTIC (72789-343-30) | August 16, 2023 |
| 72789-343-90 | 72789-343 | PD-Rx Pharmaceuticals, Inc. | 90 TABLET in 1 BOTTLE, PLASTIC (72789-343-90) | August 16, 2023 |
| 72091-009-00 | 72091-009 | PLS ANALYTICAL | 10000 TABLET in 1 BAG (72091-009-00) | May 1, 2026 |
| 72091-009-01 | 72091-009 | PLS ANALYTICAL | 100000 TABLET in 1 BAG (72091-009-01) | May 1, 2026 |
| 72091-009-02 | 72091-009 | PLS ANALYTICAL | 10 BAG in 1 DRUM (72091-009-02) / 10000 TABLET in 1 BAG | May 1, 2026 |
| 63187-110-30 | 63187-110 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (63187-110-30) | January 1, 2019 |
| 63187-110-60 | 63187-110 | Proficient Rx LP | 60 TABLET in 1 BOTTLE (63187-110-60) | July 9, 2021 |
| 63187-110-90 | 63187-110 | Proficient Rx LP | 90 TABLET in 1 BOTTLE (63187-110-90) | January 1, 2019 |
| 71205-093-15 | 71205-093 | Proficient Rx LP | 15 TABLET in 1 BOTTLE (71205-093-15) | August 1, 2018 |
| 71205-093-30 | 71205-093 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (71205-093-30) | August 1, 2018 |
| 71205-093-60 | 71205-093 | Proficient Rx LP | 60 TABLET in 1 BOTTLE (71205-093-60) | August 1, 2018 |
| 71205-093-90 | 71205-093 | Proficient Rx LP | 90 TABLET in 1 BOTTLE (71205-093-90) | August 1, 2018 |
| 71205-164-15 | 71205-164 | Proficient Rx LP | 15 TABLET in 1 BOTTLE (71205-164-15) | December 1, 2018 |
| 71205-164-30 | 71205-164 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (71205-164-30) | December 1, 2018 |
| 71205-164-60 | 71205-164 | Proficient Rx LP | 60 TABLET in 1 BOTTLE (71205-164-60) | December 1, 2018 |
| 71205-164-90 | 71205-164 | Proficient Rx LP | 90 TABLET in 1 BOTTLE (71205-164-90) | December 1, 2018 |
| 71205-207-06 | 71205-207 | Proficient Rx LP | 6 TABLET in 1 BOTTLE (71205-207-06) | September 1, 2019 |
| 71205-207-10 | 71205-207 | Proficient Rx LP | 10 TABLET in 1 BOTTLE (71205-207-10) | August 1, 2019 |
| 71205-207-15 | 71205-207 | Proficient Rx LP | 15 TABLET in 1 BOTTLE (71205-207-15) | October 1, 2019 |
| 71205-207-30 | 71205-207 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (71205-207-30) | January 1, 2019 |
| 71205-207-60 | 71205-207 | Proficient Rx LP | 60 TABLET in 1 BOTTLE (71205-207-60) | January 1, 2019 |
| 71205-207-90 | 71205-207 | Proficient Rx LP | 90 TABLET in 1 BOTTLE (71205-207-90) | January 1, 2019 |
| 56062-939-30 | 56062-939 | Publix Super Markets Inc | 30 TABLET in 1 BOTTLE (56062-939-30) | December 27, 2007 |
| 56062-939-54 | 56062-939 | Publix Super Markets Inc | 14 TABLET in 1 BLISTER PACK (56062-939-54) | December 27, 2007 |
| 56062-939-60 | 56062-939 | Publix Super Markets Inc | 60 TABLET in 1 BOTTLE (56062-939-60) | December 27, 2007 |
| 72476-764-03 | 72476-764 | RETAIL BUSINESS SERVICES,LLC. | 30 TABLET in 1 BOTTLE (72476-764-03) | April 21, 2020 |
| 72476-764-16 | 72476-764 | RETAIL BUSINESS SERVICES,LLC. | 14 TABLET in 1 BLISTER PACK (72476-764-16) | April 21, 2020 |
| 72476-764-23 | 72476-764 | RETAIL BUSINESS SERVICES,LLC. | 120 TABLET in 1 BOTTLE (72476-764-23) | April 21, 2020 |
| 72476-764-70 | 72476-764 | RETAIL BUSINESS SERVICES,LLC. | 70 TABLET in 1 BOTTLE (72476-764-70) | April 21, 2020 |
| 16571-401-10 | 16571-401 | Rising Pharma Holdings, Inc. | 100 TABLET in 1 BOTTLE (16571-401-10) | October 1, 2009 |
| 16571-402-10 | 16571-402 | Rising Pharma Holdings, Inc. | 100 TABLET in 1 BOTTLE (16571-402-10) | October 1, 2009 |
| 16571-402-30 | 16571-402 | Rising Pharma Holdings, Inc. | 300 TABLET in 1 BOTTLE (16571-402-30) | May 10, 2026 |
| 16571-402-50 | 16571-402 | Rising Pharma Holdings, Inc. | 500 TABLET in 1 BOTTLE (16571-402-50) | October 1, 2009 |
| 21130-640-03 | 21130-640 | SAFEWAY | 30 TABLET in 1 BOTTLE (21130-640-03) | June 30, 2023 |
| 21130-640-09 | 21130-640 | SAFEWAY | 90 TABLET in 1 BOTTLE (21130-640-09) | June 30, 2023 |
| 21130-640-18 | 21130-640 | SAFEWAY | 180 TABLET in 1 CARTON (21130-640-18) | June 30, 2023 |
| 66424-564-01 | 66424-564 | SDA Laboratories, Inc. | 100 TABLET in 1 BOTTLE (66424-564-01) | April 27, 2021 |
| 66424-564-05 | 66424-564 | SDA Laboratories, Inc. | 500 TABLET in 1 BOTTLE (66424-564-05) | April 27, 2021 |
| 0781-1684-01 | 0781-1684 | Sandoz Inc | 100 TABLET in 1 BOTTLE (0781-1684-01) | December 27, 2007 |
| 0781-1684-64 | 0781-1684 | Sandoz Inc | 30 TABLET in 1 BOX, UNIT-DOSE (0781-1684-64) | December 27, 2007 |
| 85766-149-01 | 85766-149 | Sportpharm LLC | 100 TABLET in 1 BOTTLE (85766-149-01) | February 6, 2026 |
| 85766-149-05 | 85766-149 | Sportpharm LLC | 500 TABLET in 1 BOTTLE (85766-149-05) | February 6, 2026 |
| 85766-149-10 | 85766-149 | Sportpharm LLC | 10 TABLET in 1 BOTTLE (85766-149-10) | February 6, 2026 |
| 85766-149-30 | 85766-149 | Sportpharm LLC | 30 TABLET in 1 BOTTLE (85766-149-30) | February 6, 2026 |
| 85766-149-60 | 85766-149 | Sportpharm LLC | 60 TABLET in 1 BOTTLE (85766-149-60) | February 6, 2026 |
| 85766-149-90 | 85766-149 | Sportpharm LLC | 90 TABLET in 1 BOTTLE (85766-149-90) | February 6, 2026 |
| 85766-205-12 | 85766-205 | Sportpharm LLC | 120 TABLET in 1 BOTTLE (85766-205-12) | May 8, 2026 |
| 85766-205-14 | 85766-205 | Sportpharm LLC | 14 TABLET in 1 BLISTER PACK (85766-205-14) | May 8, 2026 |
| 85766-205-30 | 85766-205 | Sportpharm LLC | 30 TABLET in 1 BOTTLE (85766-205-30) | May 8, 2026 |
| 60760-886-30 | 60760-886 | St. Mary's Medical Park Pharmacy | 30 TABLET in 1 BOTTLE, PLASTIC (60760-886-30) | January 17, 2023 |
| 70692-139-14 | 70692-139 | Strive Pharmaceuticals Inc | 14 TABLET in 1 BOTTLE (70692-139-14) | July 1, 2020 |
| 49483-682-01 | 49483-682 | TIME CAP LABORATORIES, INC. | 100 TABLET in 1 BOTTLE (49483-682-01) | May 30, 2022 |
| 55681-073-03 | 55681-073 | TWIN MED, LLC | 300 TABLET in 1 BOTTLE (55681-073-03) | April 1, 2026 |
| 55681-302-03 | 55681-302 | TWIN MED, LLC | 300 TABLET in 1 BOTTLE (55681-302-03) | March 2, 2022 |
| 85293-001-01 | 85293-001 | Umasuto, LLC | 100 TABLET in 1 BOTTLE (85293-001-01) | March 4, 2025 |
| 63941-939-30 | 63941-939 | Valu Merchandisers Company | 30 TABLET in 1 BOTTLE (63941-939-30) | December 27, 2007 |
| 63941-939-54 | 63941-939 | Valu Merchandisers Company | 14 TABLET in 1 BLISTER PACK (63941-939-54) | December 27, 2007 |
| 63941-939-60 | 63941-939 | Valu Merchandisers Company | 60 TABLET in 1 BOTTLE (63941-939-60) | December 27, 2007 |
| 73581-202-01 | 73581-202 | YYBA CORP | 100 TABLET in 1 BOTTLE (73581-202-01) | June 16, 2021 |
| 73581-202-05 | 73581-202 | YYBA CORP | 500 TABLET in 1 BOTTLE (73581-202-05) | June 17, 2021 |
| 52493-046 | 52493-046 | Amneal Pharmaceuticals Co. (I) Pvt. Ltd. | — | July 20, 2022 |
| 65162-045 | 65162-045 | Amneal Pharmaceuticals LLC | — | January 21, 2010 |
| 65162-046 | 65162-046 | Amneal Pharmaceuticals LLC | — | January 21, 2010 |
| 65162-145 | 65162-145 | Amneal Pharmaceuticals LLC | — | January 21, 2010 |
| 71610-821 | 71610-821 | Aphena Pharma Solutions - Tennessee, LLC | — | October 1, 2022 |
| 71610-862 | 71610-862 | Aphena Pharma Solutions - Tennessee, LLC | — | December 27, 2007 |
| 59651-097 | 59651-097 | Aurobindo Pharma Limited | — | February 28, 2017 |
| 59651-098 | 59651-098 | Aurobindo Pharma Limited | — | February 28, 2017 |
| 65862-444 | 65862-444 | Aurobindo Pharma Limited | — | August 5, 2015 |
| 65862-445 | 65862-445 | Aurobindo Pharma Limited | — | August 5, 2015 |
| 65862-446 | 65862-446 | Aurobindo Pharma Limited | — | August 5, 2015 |
| 65862-447 | 65862-447 | Aurobindo Pharma Limited | — | August 5, 2015 |
| 37835-611 | 37835-611 | Bi-Mar | — | May 1, 2025 |
| 63629-4914 | 63629-4914 | Bryant Ranch Prepack | — | October 1, 2009 |
| 71335-0300 | 71335-0300 | Bryant Ranch Prepack | — | October 1, 2009 |
| 82725-0103 | 82725-0103 | Cabinet Health P.B.C. | — | April 21, 2025 |
| 68016-939 | 68016-939 | Chain Drug Consortium, LLC | — | December 27, 2007 |
| 55319-939 | 55319-939 | FAMILY DOLLAR SERVICES, INC | — | September 1, 2017 |
| 81469-353 | 81469-353 | First Nation Group, LLC | — | May 29, 2026 |
| 69848-006 | 69848-006 | Granules USA, Inc. | — | June 30, 2021 |
| 70000-0047 | 70000-0047 | LEADER/ CARDINAL HEALTH 110, INC. | — | March 26, 2020 |
| 71141-133 | 71141-133 | LIDL US, LLC | — | September 1, 2017 |
| 68998-939 | 68998-939 | Marc Glassman, Inc. | — | November 1, 2012 |
| 10135-762 | 10135-762 | Marlex Pharmaceuticals, Inc | — | October 1, 2022 |
| 68071-1964 | 68071-1964 | NuCare Pharmaceuticals, Inc. | — | October 1, 2009 |
| 68071-2571 | 68071-2571 | NuCare Pharmaceuticals,Inc. | — | December 27, 2007 |
| 69729-139 | 69729-139 | OPMX LLC | — | July 1, 2020 |
| 51660-939 | 51660-939 | Ohm Laboratories Inc | — | November 28, 2024 |
| 55289-995 | 55289-995 | PD-Rx Pharmaceuticals, Inc. | — | December 27, 2007 |
| 72789-343 | 72789-343 | PD-Rx Pharmaceuticals, Inc. | — | December 27, 2007 |
| 72091-009 | 72091-009 | PLS ANALYTICAL | — | May 1, 2026 |
| 63187-110 | 63187-110 | Proficient Rx LP | — | December 27, 2007 |
| 71205-093 | 71205-093 | Proficient Rx LP | — | October 1, 2009 |
| 71205-164 | 71205-164 | Proficient Rx LP | — | October 1, 2009 |
| 71205-207 | 71205-207 | Proficient Rx LP | — | December 27, 2007 |
| 56062-939 | 56062-939 | Publix Super Markets Inc | — | December 27, 2007 |
| 72476-764 | 72476-764 | RETAIL BUSINESS SERVICES,LLC. | — | April 21, 2020 |
| 16571-401 | 16571-401 | Rising Pharma Holdings, Inc. | — | October 1, 2009 |
| 16571-402 | 16571-402 | Rising Pharma Holdings, Inc. | — | October 1, 2009 |
| 21130-640 | 21130-640 | SAFEWAY | — | June 30, 2023 |
| 66424-564 | 66424-564 | SDA Laboratories, Inc. | — | April 27, 2021 |
| 0781-1684 | 0781-1684 | Sandoz Inc | — | December 27, 2007 |
| 85766-149 | 85766-149 | Sportpharm LLC | — | October 1, 2009 |
| 85766-205 | 85766-205 | Sportpharm LLC | — | December 27, 2007 |
| 60760-886 | 60760-886 | St. Mary's Medical Park Pharmacy | — | January 17, 2023 |
| 70692-139 | 70692-139 | Strive Pharmaceuticals Inc | — | July 1, 2020 |
| 49483-682 | 49483-682 | TIME CAP LABORATORIES, INC. | — | May 30, 2022 |
| 55681-073 | 55681-073 | TWIN MED, LLC | — | March 2, 2022 |
| 55681-302 | 55681-302 | TWIN MED, LLC | — | March 2, 2022 |
| 85293-001 | 85293-001 | Umasuto, LLC | — | March 4, 2025 |
| 63941-939 | 63941-939 | Valu Merchandisers Company | — | December 27, 2007 |
| 73581-202 | 73581-202 | YYBA CORP | — | June 16, 2021 |
Sources for 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 |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
| Enforcement | FDA | Recall records |
Generated September 25, 2026 · 12 sections on this page.