Over-the-counter drug · ANDA
Cetirizine HCl (cetirizine) NDC 57896-992
Cetirizine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · GERI-CARE PHARMACEUTICAL CORP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57896-992-01 | 57896099201 | 100 TABLET, FILM COATED in 1 BOTTLE (57896-992-01)Marketed from Apr 24, 2025 |
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 HCl
- Generic name (nonproprietary)
- cetirizine
- Active ingredients
- Cetirizine hydrochloride — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- 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 57896-992_3389e955-a045-abfd-e063-6394a90a4e02SPL ID 3389e955-a045-abfd-e063-6394a90a4e02SPL set ID 3389e947-b7d1-6caf-e063-6294a90a2238RxCUI 1014678UNII 64O047KTOAUPC 0357896992019
- 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
N457896099201followed by a unit qualifier and the quantityPackage 57896-0992-01. 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 Hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | First Nation Group, LLC | 81469-353 |
| 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 |