Over-the-counter drug · NDA
Zyrtec (cetirizine hydrochloride) NDC 50580-753
Cetirizine hydrochloride 10 mg/1 · Tablet, Chewable · Oral · Kenvue Brands LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50580-753-24 | 50580075324 | 4 BLISTER PACK in 1 CARTON (50580-753-24) / 6 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Jun 20, 2022 |
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)
- Zyrtec
- Generic name (nonproprietary)
- cetirizine hydrochloride
- Active ingredients
- Cetirizine hydrochloride — 10 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Labeler
- Kenvue Brands LLC
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021621
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 50580-753_506ace58-15cc-77b4-e063-6394a90a0813SPL ID 506ace58-15cc-77b4-e063-6394a90a0813SPL set ID dc613bd5-70fd-1d9b-e053-2995a90a41cdRxCUI 1014674, 1020022UNII 64O047KTOAUPC 0300450250247
- 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
N450580075324followed by a unit qualifier and the quantityPackage 50580-0753-24. 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 021621
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 |
|---|---|---|---|---|
| Childrens Zyrteccetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, ChewableOral | A-S Medication Solutions | 50090-6781 |
| Childrens Zyrteccetirizine hydrochloride | Cetirizine hydrochloride 2.5 mg/1 | Tablet, ChewableOral | A-S Medication Solutions | 50090-6845 |
| Childrens Zyrteccetirizine hydrochloride | Cetirizine hydrochloride 2.5 mg/1 | Tablet, ChewableOral | Kenvue Brands LLC | 50580-790 |
| Childrens Zyrteccetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, ChewableOral | Kenvue Brands LLC | 50580-791 |