On this page
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, Film Coated
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Dr.Reddy's Laboratories Limited
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
26
Packages
86
Data completeness
82%
of corroborating sources present
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryDosage form
Tablet, Film Coated
Route of administration
Oral
Presentations
112
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
078343
Application type
ANDA · Abbreviated New Drug Application
Approval date
January 15, 2008
Sponsor
DR REDDYS LABS LTD
Products on application
4
Submissions recorded
1
| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 078343-001 | CETIRIZINE HYDROCHLORIDE HIVES | TABLET | CETIRIZINE HYDROCHLORIDE | Over-the-counter | — | ||
| 078343-002 | CETIRIZINE HYDROCHLORIDE HIVES | TABLET | CETIRIZINE HYDROCHLORIDE | Over-the-counter | — | ||
| 078343-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | TABLET | CETIRIZINE HYDROCHLORIDE | Over-the-counter | — | ||
| 078343-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | TABLET | CETIRIZINE HYDROCHLORIDE | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Original application | 1 | Approved | January 15, 2008 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260501). This is the manufacturer's labelling text, not a summary and not advice.
HUMAN OTC DRUG · 20260501 HUMAN OTC DRUG · 20260325 HUMAN OTC DRUG · 20251031 HUMAN OTC DRUG · 20251028
Recent Major Changes
openFDA Drug LabelingCetirizine HCL 10MG
Indications and Usage
openFDA Drug LabelingUses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1. runny nose 2. sneezing 3. itchy, watery eyes 4. itching of the nose or throat .
Purpose
openFDA Drug LabelingPurpose Antihistamine
Dosage and Administration
openFDA Drug LabelingDIRECTIONS adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor Other information store between 20° to 25°C (68° to 77°F) do not use if foil inner seal is broken or missing FDA approved dissolution test specifications differ from USP Inactive ingredients anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide Questions? Call at +1-855-642-2594
Warnings
openFDA Drug LabelingWarnings Ask a doctor before use if you have Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistaminecontaining hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product 1. drowsiness may occur 2. avoid alcoholic drinks 3. alcohol, sedatives, and tranquilizers may increase drowsiness 4. be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: 1. If breast-feeding: not recommended 2. if pregnant: ask a health professional before use. Keep out of reach of children 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 LabelingDo 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 a Doctor
openFDA Drug LabelingAsk a doctor before use if you have Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistaminecontaining hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
Stop Use
openFDA Drug LabelingStop use and ask a doctor if Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
Active Ingredient
openFDA Drug LabelingActive Ingredient (in each tablet) Cetirizine hydrochloride USP, 10 mg
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Cetirizine Hydrochloride 10mg Tablets NDC 71335-9612-1: 30 Tablets in a BOTTLE NDC 71335-9612-2: 14 Tablets in a BOTTLE NDC 71335-9612-3: 7 Tablets in a BOTTLE NDC 71335-9612-4: 10 Tablets in a BOTTLE NDC 71335-9612-5: 15 Tablets in a BOTTLE NDC 71335-9612-6: 90 Tablets in a BOTTLE NDC 71335-9612-7: 20 Tablets in a BOTTLE NDC 71335-9612-8: 60 Tablets in a BOTTLE NDC 71335-9612-9: 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.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 69452-465-81 | 69452-465 | Bionpharma Inc. | 400 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-465-81) | October 20, 2024 |
| 71335-9612-1 | 71335-9612 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-9612-1) | January 3, 2023 |
| 71335-9612-2 | 71335-9612 | Bryant Ranch Prepack | 14 TABLET, FILM COATED in 1 BOTTLE (71335-9612-2) | January 3, 2023 |
| 71335-9612-3 | 71335-9612 | Bryant Ranch Prepack | 7 TABLET, FILM COATED in 1 BOTTLE (71335-9612-3) | January 3, 2023 |
| 71335-9612-4 | 71335-9612 | Bryant Ranch Prepack | 10 TABLET, FILM COATED in 1 BOTTLE (71335-9612-4) | January 3, 2023 |
| 71335-9612-5 | 71335-9612 | Bryant Ranch Prepack | 15 TABLET, FILM COATED in 1 BOTTLE (71335-9612-5) | January 3, 2023 |
| 71335-9612-6 | 71335-9612 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-9612-6) | January 3, 2023 |
| 71335-9612-7 | 71335-9612 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (71335-9612-7) | January 3, 2023 |
| 71335-9612-8 | 71335-9612 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-9612-8) | January 3, 2023 |
| 71335-9612-9 | 71335-9612 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-9612-9) | January 3, 2023 |
| 72162-2173-2 | 72162-2173 | Bryant Ranch Prepack | 1 BOTTLE in 1 CARTON (72162-2173-2) / 300 TABLET, FILM COATED in 1 BOTTLE | January 23, 2024 |
| 72162-2173-3 | 72162-2173 | Bryant Ranch Prepack | 1 BOTTLE in 1 CARTON (72162-2173-3) / 30 TABLET, FILM COATED in 1 BOTTLE | June 18, 2024 |
| 55154-5399-0 | 55154-5399 | Cardinal Health 107, LLC | 10 BLISTER PACK in 1 BAG (55154-5399-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK | March 30, 2012 |
| 53943-519-30 | 53943-519 | Discount Drug Mart, Inc | 1 BOTTLE in 1 CARTON (53943-519-30) / 30 TABLET, FILM COATED in 1 BOTTLE | January 20, 2020 |
| 53943-519-45 | 53943-519 | Discount Drug Mart, Inc | 1 BOTTLE in 1 CARTON (53943-519-45) / 45 TABLET, FILM COATED in 1 BOTTLE | January 20, 2020 |
| 43598-183-31 | 43598-183 | Dr. Reddy's Laboratories Inc. | 300 TABLET, FILM COATED in 1 BOTTLE (43598-183-31) | April 1, 2024 |
| 43598-183-55 | 43598-183 | Dr. Reddy's Laboratories Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (43598-183-55) | November 1, 2023 |
| 43598-811-05 | 43598-811 | Dr. Reddy's Laboratories Inc. | 1 BOTTLE in 1 CARTON (43598-811-05) / 500 TABLET, FILM COATED in 1 BOTTLE | December 17, 2018 |
| 43598-811-12 | 43598-811 | Dr. Reddy's Laboratories Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (43598-811-12) | September 3, 2019 |
| 43598-811-13 | 43598-811 | Dr. Reddy's Laboratories Inc. | 300 TABLET, FILM COATED in 1 BOTTLE (43598-811-13) | September 3, 2019 |
| 43598-811-15 | 43598-811 | Dr. Reddy's Laboratories Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (43598-811-15) | September 3, 2019 |
| 43598-811-30 | 43598-811 | Dr. Reddy's Laboratories Inc. | 1 BOTTLE in 1 CARTON (43598-811-30) / 300 TABLET, FILM COATED in 1 BOTTLE | December 17, 2018 |
| 43598-811-90 | 43598-811 | Dr. Reddy's Laboratories Inc. | 1 BOTTLE in 1 CARTON (43598-811-90) / 90 TABLET, FILM COATED in 1 BOTTLE | December 17, 2018 |
| 55111-351-04 | 55111-351 | Dr.Reddy's Laboratories Limited | 1 BOTTLE in 1 CARTON (55111-351-04) / 120 TABLET, FILM COATED in 1 BOTTLE | January 15, 2008 |
| 55111-351-30 | 55111-351 | Dr.Reddy's Laboratories Limited | 1 BOTTLE in 1 CARTON (55111-351-30) / 30 TABLET, FILM COATED in 1 BOTTLE | January 15, 2008 |
| 55111-351-45 | 55111-351 | Dr.Reddy's Laboratories Limited | 1 BOTTLE in 1 CARTON (55111-351-45) / 45 TABLET, FILM COATED in 1 BOTTLE | January 15, 2008 |
| 55111-351-47 | 55111-351 | Dr.Reddy's Laboratories Limited | 2 BOTTLE in 1 CARTON (55111-351-47) / 175 TABLET, FILM COATED in 1 BOTTLE | January 15, 2008 |
| 55111-351-51 | 55111-351 | Dr.Reddy's Laboratories Limited | 1 BOTTLE in 1 CARTON (55111-351-51) / 75 TABLET, FILM COATED in 1 BOTTLE | January 15, 2008 |
| 55111-351-60 | 55111-351 | Dr.Reddy's Laboratories Limited | 1 BOTTLE in 1 CARTON (55111-351-60) / 60 TABLET, FILM COATED in 1 BOTTLE | January 15, 2008 |
| 55111-351-74 | 55111-351 | Dr.Reddy's Laboratories Limited | 2 BLISTER PACK in 1 CARTON (55111-351-74) / 7 TABLET, FILM COATED in 1 BLISTER PACK | January 15, 2008 |
| 55111-351-90 | 55111-351 | Dr.Reddy's Laboratories Limited | 1 BOTTLE in 1 CARTON (55111-351-90) / 90 TABLET, FILM COATED in 1 BOTTLE | January 15, 2008 |
| 55111-699-04 | 55111-699 | Dr.Reddy's Laboratories Limited | 1 BOTTLE in 1 CARTON (55111-699-04) / 120 TABLET, FILM COATED in 1 BOTTLE | April 11, 2008 |
| 55111-699-15 | 55111-699 | Dr.Reddy's Laboratories Limited | 1 BLISTER PACK in 1 CARTON (55111-699-15) / 14 TABLET, FILM COATED in 1 BLISTER PACK | April 4, 2008 |
| 55111-699-19 | 55111-699 | Dr.Reddy's Laboratories Limited | 1 BOTTLE in 1 CARTON (55111-699-19) / 175 TABLET, FILM COATED in 1 BOTTLE | January 15, 2008 |
| 55111-699-30 | 55111-699 | Dr.Reddy's Laboratories Limited | 1 BOTTLE in 1 CARTON (55111-699-30) / 30 TABLET, FILM COATED in 1 BOTTLE | April 3, 2008 |
| 55111-699-31 | 55111-699 | Dr.Reddy's Laboratories Limited | 1 BOTTLE in 1 CARTON (55111-699-31) / 300 TABLET, FILM COATED in 1 BOTTLE | September 27, 2016 |
| 55111-699-45 | 55111-699 | Dr.Reddy's Laboratories Limited | 1 BOTTLE in 1 CARTON (55111-699-45) / 45 TABLET, FILM COATED in 1 BOTTLE | April 8, 2008 |
| 55111-699-47 | 55111-699 | Dr.Reddy's Laboratories Limited | 2 BOTTLE in 1 CARTON (55111-699-47) / 175 TABLET, FILM COATED in 1 BOTTLE | April 3, 2008 |
| 55111-699-51 | 55111-699 | Dr.Reddy's Laboratories Limited | 1 BOTTLE in 1 CARTON (55111-699-51) / 75 TABLET, FILM COATED in 1 BOTTLE | July 22, 2008 |
| 55111-699-52 | 55111-699 | Dr.Reddy's Laboratories Limited | 1 BOTTLE in 1 CARTON (55111-699-52) / 14 TABLET, FILM COATED in 1 BOTTLE | October 6, 2010 |
| 55111-699-60 | 55111-699 | Dr.Reddy's Laboratories Limited | 1 BOTTLE in 1 CARTON (55111-699-60) / 60 TABLET, FILM COATED in 1 BOTTLE | April 7, 2008 |
| 55111-699-73 | 55111-699 | Dr.Reddy's Laboratories Limited | 1 BOTTLE in 1 CARTON (55111-699-73) / 365 TABLET, FILM COATED in 1 BOTTLE | October 6, 2010 |
| 55111-699-74 | 55111-699 | Dr.Reddy's Laboratories Limited | 2 BLISTER PACK in 1 CARTON (55111-699-74) / 7 TABLET, FILM COATED in 1 BLISTER PACK | April 4, 2008 |
| 55111-699-90 | 55111-699 | Dr.Reddy's Laboratories Limited | 90 TABLET, FILM COATED in 1 BOTTLE (55111-699-90) | April 8, 2008 |
| 55111-699-96 | 55111-699 | Dr.Reddy's Laboratories Limited | 7500 TABLET, FILM COATED in 1 POUCH (55111-699-96) | January 10, 2010 |
| 14445-152-01 | 14445-152 | Indoco Remedies Limited | 1 BOTTLE in 1 CARTON (14445-152-01) / 100 TABLET, FILM COATED in 1 BOTTLE | October 4, 2024 |
| 14445-152-03 | 14445-152 | Indoco Remedies Limited | 1 BOTTLE in 1 CARTON (14445-152-03) / 300 TABLET, FILM COATED in 1 BOTTLE | October 4, 2024 |
| 14445-152-05 | 14445-152 | Indoco Remedies Limited | 1 BOTTLE in 1 CARTON (14445-152-05) / 500 TABLET, FILM COATED in 1 BOTTLE | October 4, 2024 |
| 14445-152-30 | 14445-152 | Indoco Remedies Limited | 1 BOTTLE in 1 CARTON (14445-152-30) / 30 TABLET, FILM COATED in 1 BOTTLE | October 4, 2024 |
| 14445-152-90 | 14445-152 | Indoco Remedies Limited | 1 BOTTLE in 1 CARTON (14445-152-90) / 90 TABLET, FILM COATED in 1 BOTTLE | October 4, 2024 |
| 62579-726-00 | 62579-726 | Janssen Cilag SpA | 18277 TABLET, FILM COATED in 1 DRUM (62579-726-00) | October 1, 2008 |
| 17314-705-00 | 17314-705 | Janssen Ortho LLC | 571500 TABLET, FILM COATED in 1 DRUM (17314-705-00) | October 1, 2008 |
| 17314-737-00 | 17314-737 | Janssen Ortho LLC | 285700 TABLET, FILM COATED in 1 DRUM (17314-737-00) | October 1, 2008 |
| 51079-597-20 | 51079-597 | Mylan Institutional Inc. | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-597-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-597-01) | March 30, 2012 |
| 0378-3635-01 | 0378-3635 | Mylan Pharmaceuticals Inc. | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3635-01) | December 27, 2007 |
| 0378-3637-01 | 0378-3637 | Mylan Pharmaceuticals Inc. | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3637-01) | December 27, 2007 |
| 0378-3637-05 | 0378-3637 | Mylan Pharmaceuticals Inc. | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3637-05) | December 27, 2007 |
| 51655-801-52 | 51655-801 | Northwind Health Company, LLC | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-801-52) | January 25, 2023 |
| 51655-801-60 | 51655-801 | Northwind Health Company, LLC | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-801-60) | January 25, 2023 |
| 51655-801-84 | 51655-801 | Northwind Health Company, LLC | 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-801-84) | January 25, 2023 |
| 72789-458-10 | 72789-458 | PD-Rx Pharmaceuticals, Inc. | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-458-10) | October 23, 2025 |
| 72789-458-30 | 72789-458 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-458-30) | May 29, 2025 |
| 72789-458-51 | 72789-458 | PD-Rx Pharmaceuticals, Inc. | 365 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-458-51) | April 23, 2025 |
| 72789-458-90 | 72789-458 | PD-Rx Pharmaceuticals, Inc. | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-458-90) | May 29, 2025 |
| 45802-919-39 | 45802-919 | Padagis Israel Pharmaceuticals Ltd | 1 BOTTLE in 1 CARTON (45802-919-39) / 30 TABLET, FILM COATED in 1 BOTTLE | October 15, 2008 |
| 45802-919-87 | 45802-919 | Padagis Israel Pharmaceuticals Ltd | 1 BOTTLE in 1 CARTON (45802-919-87) / 300 TABLET, FILM COATED in 1 BOTTLE | December 27, 2007 |
| 68788-4072-3 | 68788-4072 | Preferred Pharmaceuticals Inc. | 1 BOTTLE in 1 CARTON (68788-4072-3) / 30 TABLET, FILM COATED in 1 BOTTLE | January 27, 2026 |
| 68788-4072-6 | 68788-4072 | Preferred Pharmaceuticals Inc. | 60 TABLET, FILM COATED in 1 BOTTLE (68788-4072-6) | January 27, 2026 |
| 68788-4072-9 | 68788-4072 | Preferred Pharmaceuticals Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (68788-4072-9) | January 27, 2026 |
| 68788-8435-3 | 68788-8435 | Preferred Pharmaceuticals Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8435-3) | April 27, 2023 |
| 68788-8435-6 | 68788-8435 | Preferred Pharmaceuticals Inc. | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8435-6) | April 27, 2023 |
| 68788-8435-9 | 68788-8435 | Preferred Pharmaceuticals Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8435-9) | April 27, 2023 |
| 71205-709-00 | 71205-709 | Proficient Rx LP | 100 TABLET, FILM COATED in 1 BOTTLE (71205-709-00) | July 8, 2025 |
| 71205-709-06 | 71205-709 | Proficient Rx LP | 6 TABLET, FILM COATED in 1 BOTTLE (71205-709-06) | October 31, 2022 |
| 71205-709-10 | 71205-709 | Proficient Rx LP | 10 TABLET, FILM COATED in 1 BOTTLE (71205-709-10) | October 31, 2022 |
| 71205-709-20 | 71205-709 | Proficient Rx LP | 20 TABLET, FILM COATED in 1 BOTTLE (71205-709-20) | March 4, 2026 |
| 71205-709-30 | 71205-709 | Proficient Rx LP | 30 TABLET, FILM COATED in 1 BOTTLE (71205-709-30) | October 31, 2022 |
| 71205-709-90 | 71205-709 | Proficient Rx LP | 90 TABLET, FILM COATED in 1 BOTTLE (71205-709-90) | October 31, 2022 |
| 48433-017-20 | 48433-017 | Safecor Health, LLC | 100 BLISTER PACK in 1 CARTON (48433-017-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (48433-017-01) | April 17, 2026 |
| 85766-045-05 | 85766-045 | Sportpharm LLC | 500 TABLET, FILM COATED in 1 BOTTLE (85766-045-05) | August 2, 2025 |
| 70677-1007-2 | 70677-1007 | Strategic Sourcing Services LLC | 1 BOTTLE in 1 CARTON (70677-1007-2) / 60 TABLET, FILM COATED in 1 BOTTLE | May 5, 2023 |
| 70677-1007-3 | 70677-1007 | Strategic Sourcing Services LLC | 1 BOTTLE in 1 CARTON (70677-1007-3) / 90 TABLET, FILM COATED in 1 BOTTLE | May 5, 2023 |
| 70677-1007-4 | 70677-1007 | Strategic Sourcing Services LLC | 1 BOTTLE in 1 CARTON (70677-1007-4) / 300 TABLET, FILM COATED in 1 BOTTLE | May 5, 2023 |
| 83939-0004-1 | 83939-0004 | VERITYRX, LLC | 1 TABLET, FILM COATED in 1 POUCH (83939-0004-1) | November 10, 2025 |
| 83939-0004-2 | 83939-0004 | VERITYRX, LLC | 50 POUCH in 1 BOX, UNIT-DOSE (83939-0004-2) / 1 TABLET, FILM COATED in 1 POUCH | November 3, 2025 |
| 83939-0004-3 | 83939-0004 | VERITYRX, LLC | 100 POUCH in 1 BOX, UNIT-DOSE (83939-0004-3) / 1 TABLET, FILM COATED in 1 POUCH | November 3, 2025 |
| 69452-465 | 69452-465 | Bionpharma Inc. | — | October 20, 2024 |
| 71335-9612 | 71335-9612 | Bryant Ranch Prepack | — | December 17, 2018 |
| 72162-2173 | 72162-2173 | Bryant Ranch Prepack | — | December 27, 2007 |
| 55154-5399 | 55154-5399 | Cardinal Health 107, LLC | — | March 30, 2012 |
| 53943-519 | 53943-519 | Discount Drug Mart, Inc | — | January 20, 2020 |
| 43598-183 | 43598-183 | Dr. Reddy's Laboratories Inc. | — | December 17, 2018 |
| 43598-811 | 43598-811 | Dr. Reddy's Laboratories Inc. | — | December 17, 2018 |
| 55111-351 | 55111-351 | Dr.Reddy's Laboratories Limited | — | January 15, 2008 |
| 55111-699 | 55111-699 | Dr.Reddy's Laboratories Limited | — | January 10, 2010 |
| 14445-152 | 14445-152 | Indoco Remedies Limited | — | October 4, 2024 |
| 62579-726 | 62579-726 | Janssen Cilag SpA | — | October 1, 2008 |
| 17314-705 | 17314-705 | Janssen Ortho LLC | — | October 1, 2008 |
| 17314-737 | 17314-737 | Janssen Ortho LLC | — | October 1, 2008 |
| 51079-597 | 51079-597 | Mylan Institutional Inc. | — | March 30, 2012 |
| 0378-3635 | 0378-3635 | Mylan Pharmaceuticals Inc. | — | December 27, 2007 |
| 0378-3637 | 0378-3637 | Mylan Pharmaceuticals Inc. | — | December 27, 2007 |
| 51655-801 | 51655-801 | Northwind Health Company, LLC | — | January 25, 2023 |
| 72789-458 | 72789-458 | PD-Rx Pharmaceuticals, Inc. | — | April 23, 2025 |
| 45802-919 | 45802-919 | Padagis Israel Pharmaceuticals Ltd | — | December 27, 2007 |
| 68788-4072 | 68788-4072 | Preferred Pharmaceuticals Inc. | — | January 27, 2026 |
| 68788-8435 | 68788-8435 | Preferred Pharmaceuticals Inc. | — | April 27, 2023 |
| 71205-709 | 71205-709 | Proficient Rx LP | — | December 17, 2018 |
| 48433-017 | 48433-017 | Safecor Health, LLC | — | April 17, 2026 |
| 85766-045 | 85766-045 | Sportpharm LLC | — | December 17, 2018 |
| 70677-1007 | 70677-1007 | Strategic Sourcing Services LLC | — | May 12, 2022 |
| 83939-0004 | 83939-0004 | VERITYRX, LLC | — | December 17, 2018 |
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 |
Generated September 25, 2026 · 11 sections on this page.