Over-the-counter drug · ANDA
Cetirizine Hydrochloride NDC 81469-353
Cetirizine hydrochloride 10 mg/1 · Tablet · Oral · First Nation Group, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81469-353-01 | 81469035301 | 100 TABLET in 1 BOTTLE (81469-353-01)Marketed from Jun 1, 2026 | |
| 81469-353-03 | 81469035303 | 300 TABLET in 1 BOTTLE (81469-353-03)Marketed from Jun 1, 2026 | |
| 81469-353-05 | 81469035305 | 500 TABLET in 1 BOTTLE (81469-353-05)Marketed from Jun 1, 2026 | |
| 81469-353-90 | 81469035390 | 90 TABLET in 1 BOTTLE (81469-353-90)Marketed from Jun 1, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
- First Nation Group, LLC
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076047
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 81469-353_5359e5b7-5279-c7fc-e063-6394a90a378bSPL ID 5359e5b7-5279-c7fc-e063-6394a90a378bSPL set ID 5267f7c0-e62f-35da-e063-6394a90a9346RxCUI 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
N481469035301followed by a unit qualifier and the quantityPackage 81469-0353-01. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
USES 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
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076047
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 |
|---|---|---|---|---|
| Cetirizine HClcetirizine | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | GERI-CARE PHARMACEUTICAL CORP | 57896-992 |
| Dr Simi Cetirizine Hydrochloride 10 mgcetirizine hydrochloride 10 mg | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Farmacias De Similares TX LLC | 85786-203 |
| cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-458 |
| Cetirizine Hydrochloride 10 mg | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Contract Pharmacal Corp. | 10267-3579 |