Over-the-counter drug · NDA
Childrens Zyrtec (Cetirizine hydrochloride) NDC 50580-791
Cetirizine hydrochloride 10 mg/1 · Tablet, Chewable · Oral · Kenvue Brands LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50580-791-01 | 5058007910150580079101 | 4 BLISTER PACK in 1 CARTON (50580-791-01) / 6 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Jun 21, 2021 | |
| 50580-791-02 | 5058007910250580079102 | 8 BLISTER PACK in 1 CARTON (50580-791-02) / 6 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Jan 1, 2023 | |
| 50580-791-03 | 5058007910350580079103 | 1 BLISTER PACK in 1 CARTON (50580-791-03) / 6 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Sep 1, 2022 | |
| 50580-791-72 | 5058007917250580079172 | 3 BLISTER PACK in 1 CARTON (50580-791-72) / 24 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Jan 15, 2024 |
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)
- Childrens Zyrtec
- Generic name (nonproprietary)
- cetirizine hydrochloride
- Active ingredients
- Cetirizine hydrochloride — 10 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Labeler
- Kenvue Brands LLCNDC labeler code 50580
- 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 50580-791_500a1503-02c8-cc05-e063-6394a90a24fbSPL ID 500a1503-02c8-cc05-e063-6394a90a24fbSPL set ID 0fe77356-d945-46a0-882e-b3bbab784556RxCUI 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
N450580079101followed by a unit qualifier and the quantityPackage 50580-0791-01. 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: sneezing runny nose itchy, watery eyes itching of the nose or throat
Excerpt only. Read the full label for complete information.
About NDC 50580-791
- What is NDC 50580-791?
- 50580-791 is the product NDC for Childrens Zyrtec (cetirizine hydrochloride), Cetirizine hydrochloride 10 mg/1 tablet, chewable, listed with the FDA by Kenvue Brands LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Childrens Zyrtec (Cetirizine hydrochloride).
- What is the active ingredient?
- Cetirizine hydrochloride.
- Who is the labeler?
- Kenvue Brands LLC, NDC labeler code 50580. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Childrens Zyrtec?
- 4 other product NDCs are listed under this name. See all Childrens Zyrtec NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Childrens Zyrtec products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Childrens Zyrteccetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, ChewableOral | A-S Medication Solutions | 50090-6781 | 50090-6781-00 |
| Childrens Zyrteccetirizine hydrochloride | Cetirizine hydrochloride 2.5 mg/1 | Tablet, ChewableOral | A-S Medication Solutions | 50090-6845 | 50090-6845-00 |
| Childrens Zyrteccetirizine hydrochloride | Cetirizine hydrochloride 2.5 mg/1 | Tablet, ChewableOral | Kenvue Brands LLC | 50580-790 | 50580-0790-0150580-0790-0250580-0790-03 |
| Childrens Zyrteccetirizine hydrochloride | Cetirizine hydrochloride 5 mg/5mL | SyrupOral | Kenvue Brands LLC | 50580-730 | 50580-0730-0150580-0730-0550580-0730-06+3 more |
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 |
| Zyrteccetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, ChewableOral | Kenvue Brands LLC | 50580-753 |