Over-the-counter drug · NDA
Childrens Zyrtec Allergy (Cetirizine hydrochloride) NDC 50580-721
Cetirizine hydrochloride 5 mg/5mL · Syrup · Oral · Kenvue Brands LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50580-721-05 | 5058007210550580072105 | 1 BOTTLE, PLASTIC in 1 CARTON (50580-721-05) / 118 mL in 1 BOTTLE, PLASTICMarketed from Jul 13, 2015 |
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 Allergy
- Generic name (nonproprietary)
- cetirizine hydrochloride
- Active ingredients
- Cetirizine hydrochloride — 5 mg/5mL
- Dosage form
- Syrup
- Route
- Oral
- Labeler
- Kenvue Brands LLCNDC labeler code 50580
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022155
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 50580-721_48bb7dd3-c2b8-ecfb-e063-6294a90af77dSPL ID 48bb7dd3-c2b8-ecfb-e063-6294a90af77dSPL set ID ee8695ac-1293-4e43-ac7c-a64e21a0ca0aRxCUI 1014673, 1020021UNII 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
N450580072105followed by a unit qualifier and the quantityPackage 50580-0721-05. 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.
About NDC 50580-721
- What is NDC 50580-721?
- 50580-721 is the product NDC for Childrens Zyrtec Allergy (cetirizine hydrochloride), Cetirizine hydrochloride 5 mg/5mL syrup, listed with the FDA by Kenvue Brands LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Childrens Zyrtec Allergy (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 Allergy?
- 1 other product NDC are listed under this name. See all Childrens Zyrtec Allergy 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 Allergy 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 Zyrtec Allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Orally disintegratingOral | Kenvue Brands LLC | 50580-782 | 50580-0782-0150580-0782-1250580-0782-24 |
Other NDCs under NDA 022155
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 5 mg/5mL | SyrupOral | Kenvue Brands LLC | 50580-730 |
| Zyrtec Hivescetirizine hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Kenvue Brands LLC | 50580-128 |