Over-the-counter drug · ANDA
Allergy Relief (cetirizine tablets) NDC 53943-130
Cetirizine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · DISCOUNT DRUG MART, INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53943-130-13 | 53943013013 | 1 BOTTLE, PLASTIC in 1 CARTON (53943-130-13) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from May 20, 2026 | |
| 53943-130-17 | 53943013017 | 1 BOTTLE, PLASTIC in 1 CARTON (53943-130-17) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from May 20, 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)
- Allergy Relief
- Generic name (nonproprietary)
- cetirizine tablets
- Active ingredients
- Cetirizine hydrochloride — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- DISCOUNT DRUG MART, INC
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078862
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 53943-130_502476ab-e17d-bf5a-e063-6294a90a84feSPL ID 502476ab-e17d-bf5a-e063-6294a90a84feSPL set ID 4b9576dc-d7f9-dc10-e063-6294a90a233eRxCUI 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
N453943013013followed by a unit qualifier and the quantityPackage 53943-0130-13. 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 078862
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 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-465 |
| Hives Reliefcetirizine tablets | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | WALGREEN COMPANY | 0363-6340 |