Over-the-counter drug · NDA
Cetirizine HCl NDC 80136-856
Cetirizine hydrochloride 10 mg/1 · Capsule · Oral · Northeast Pharma
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80136-856-23 | 80136085623 | 1 BOTTLE, PLASTIC in 1 CARTON (80136-856-23) / 25 CAPSULE in 1 BOTTLE, PLASTICMarketed from Sep 26, 2023 |
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 hcl
- Active ingredients
- Cetirizine hydrochloride — 10 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Northeast Pharma
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022429
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 80136-856_0647ef67-e7f9-a73e-e063-6294a90abe76SPL ID 0647ef67-e7f9-a73e-e063-6294a90abe76SPL set ID 0647ef4c-8912-9f44-e063-6294a90ae3a6RxCUI 1014675UNII 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
N480136085623followed by a unit qualifier and the quantityPackage 80136-0856-23. 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 NDA 022429
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 |
|---|---|---|---|---|
| 24 Hour Allergycetirizine hcl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | Walgreens | 0363-1219 |
| Cetirizine HCl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | Meijer Distribution Inc | 79481-0670 |
| Cetirizine HCl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | Meijer Distribution Inc | 79481-0671 |
| Cetirizine HCl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | TOP CARE (Topco Associates LLC) | 36800-542 |
| Cetirizine HCl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | TOP CARE (Topco Associates LLC) | 36800-543 |
| Cetirizine HCl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | Bionpharma Inc. | 69452-479 |
| Cetirizine HCl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | AMERISOURCE BERGEN | 46122-815 |
| all day allergycetirizine hcl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | SUPERVALU INC | 41163-219 |
| Cetirizine HCl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | CVS Pharmacy | 51316-900 |
| Cetirizine HCl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | KROGER COMPANY | 30142-995 |
| Cetirizine HCl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | KROGER COMPANY | 59450-020 |
| Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | Whole Foods Market, INC. | 42681-0056 |
| Cetirizine HCl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | TARGET Corporation | 11673-242 |
| All Day Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | CHAIN DRUG MARKETING ASSOCIATION INC. | 63868-433 |
| Cetirizine HCl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | PUBLIX SUPER MARKETS INC | 56062-452 |
| Cetirizine HCl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | PUBLIX SUPER MARKETS INC | 56062-495 |
| Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | DISCOUNT DRUG MART, INC. | 53943-219 |
| Cetirizine HCl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | DOLGENCORP INC | 55910-784 |
| Cetirizine HCl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | AMERISOURCE BERGEN | 46122-613 |
| Cetirizine HCl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | Bionpharma Inc. | 69452-265 |
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