Over-the-counter drug · ANDA
Cetirizine Hydrochloride NDC 0378-3635
Cetirizine hydrochloride 5 mg/1 · Tablet, Film coated · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-3635-01 | 00378363501 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3635-01)Marketed from Dec 27, 2007 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076677
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0378-3635_5670c6c3-a4ab-4268-917a-99e0579f3079SPL ID 5670c6c3-a4ab-4268-917a-99e0579f3079SPL set ID 487ae0f0-320c-4534-b9e2-0e215f167ceaRxCUI 1014676, 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
N400378363501followed by a unit qualifier and the quantityPackage 00378-3635-01. 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 076677
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 | Mylan Institutional Inc. | 51079-597 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Safecor Health, LLC | 48433-017 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-3637 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-5399 |