Over-the-counter drug · NDA
Childrens Zyrtec (cetirizine hydrochloride) NDC 50090-6781
Cetirizine hydrochloride 10 mg/1 · Tablet, Chewable · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-6781-0 | 50090678100 | 4 BLISTER PACK in 1 CARTON (50090-6781-0) / 6 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Oct 26, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Childrens Zyrtec
- Generic name (nonproprietary)
- cetirizine hydrochloride
- Active ingredients
- Cetirizine hydrochloride — 10 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Labeler
- A-S Medication Solutions
- 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 50090-6781_b5000f03-33a3-48ae-b0bf-66a3c52c50afSPL ID b5000f03-33a3-48ae-b0bf-66a3c52c50afSPL set ID 5c19a07e-09f4-46ed-939c-d21fe3e811f6RxCUI 1014674, 1020022UNII 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
N450090678100followed by a unit qualifier and the quantityPackage 50090-6781-00. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 2.5 mg/1 | Tablet, ChewableOral | A-S Medication Solutions | 50090-6845 |
| Zyrteccetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, ChewableOral | Kenvue Brands LLC | 50580-753 |
| 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 |