Over-the-counter drug · ANDA
Cetirizine Hydrochloride NDC 71335-0300
Cetirizine hydrochloride 10 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0300-1 | 71335030001 | 30 TABLET in 1 BOTTLE (71335-0300-1)Marketed from Feb 16, 2018 | |
| 71335-0300-2 | 71335030002 | 14 TABLET in 1 BOTTLE (71335-0300-2)Marketed from Feb 20, 2018 | |
| 71335-0300-3 | 71335030003 | 7 TABLET in 1 BOTTLE (71335-0300-3)Marketed from Feb 9, 2022 | |
| 71335-0300-4 | 71335030004 | 10 TABLET in 1 BOTTLE (71335-0300-4)Marketed from Mar 19, 2019 | |
| 71335-0300-5 | 71335030005 | 15 TABLET in 1 BOTTLE (71335-0300-5)Marketed from Feb 9, 2022 | |
| 71335-0300-6 | 71335030006 | 90 TABLET in 1 BOTTLE (71335-0300-6)Marketed from Feb 16, 2018 | |
| 71335-0300-7 | 71335030007 | 20 TABLET in 1 BOTTLE (71335-0300-7)Marketed from Mar 7, 2019 | |
| 71335-0300-8 | 71335030008 | 60 TABLET in 1 BOTTLE (71335-0300-8)Marketed from Oct 13, 2021 | |
| 71335-0300-9 | 71335030009 | 100 TABLET in 1 BOTTLE (71335-0300-9)Marketed from May 3, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Cetirizine Hydrochloride
- Generic name (nonproprietary)
- cetirizine hydrochloride
- Active ingredients
- Cetirizine hydrochloride — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077829
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 71335-0300_80b8a53e-8bc2-4bd7-b002-a7736af37618SPL ID 80b8a53e-8bc2-4bd7-b002-a7736af37618SPL set ID 4b192084-dfdc-47bc-a968-6f49e137b248RxCUI 1014678UNII 64O047KTOA
- Pharmacologic class
- Histamine-1 Receptor Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N471335030001followed by a unit qualifier and the quantityPackage 71335-0300-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 077829
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Cabinet Allergy Relief Refill Cetirizine HCIcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Cabinet Health P.B.C. | 82725-3003 |
| Cabinet All Day Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Cabinet Health P.B.C. | 82725-3103 |
| Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Strategic Sourcing Services LLC | 70677-1241 |
| ValuMeds All Day Allergy Cetirizine Hydrochloridecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Cabinet Health P.B.C. | 82725-1103 |
| Goodmeds All Day Allergy Relief Cetirizine HClcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Cabinet Health P.B.C. | 82725-4103 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-1964 |
| CVS Cetirizine Hydrochloridecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | CVS Pharmacy | 51316-182 |
| Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Prodose, Inc | 68210-4159 |
| Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | TabletOral | Pioneer Life Sciences, LLC | 72090-028 |
| Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | TabletOral | Pioneer Life Sciences, LLC | 72090-028 |
| Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | TabletOral | Pioneer Life Sciences, LLC | 72090-028 |
| Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | TabletOral | Pioneer Life Sciences, LLC | 72090-028 |
| RIGHT REMEDIES ALL-DAY Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Strive Pharmaceuticals Inc. | 70692-180 |
| GOOD REMEDIES All Day Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Strive Pharmaceuticals Inc. | 70692-801 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-4914 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 5 mg/1 | TabletOral | Proficient Rx LP | 71205-093 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Umasuto, LLC | 85293-001 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-402 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 5 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-401 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Proficient Rx LP | 71205-164 |
Showing 20 of 25.