Over-the-counter drug · NDA
ZYRTEC Hives (Cetirizine hydrochloride) NDC 50580-116
Cetirizine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Kenvue Brands LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50580-116-30 | 5058001163050580011630 | 1 BOTTLE in 1 CARTON (50580-116-30) / 30 TABLET, FILM COATED in 1 BOTTLEMarketed from Jun 2, 2025 |
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 Hives
- Generic name (nonproprietary)
- cetirizine hydrochloride
- Active ingredients
- Cetirizine hydrochloride — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Kenvue Brands LLCNDC labeler code 50580
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019835
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 50580-116_37b38291-50c9-00c9-e063-6394a90a83efSPL ID 37b38291-50c9-00c9-e063-6394a90a83efSPL set ID 31136e3a-94fa-0860-e063-6394a90a008dRxCUI 1014678, 1020026UNII 64O047KTOAUPC 0300450138323
- 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
N450580011630followed by a unit qualifier and the quantityPackage 50580-0116-30. 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 reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.
Excerpt only. Read the full label for complete information.
About NDC 50580-116
- What is NDC 50580-116?
- 50580-116 is the product NDC for ZYRTEC Hives (cetirizine hydrochloride), Cetirizine hydrochloride 10 mg/1 tablet, film coated, 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?
- ZYRTEC Hives (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 ZYRTEC Hives?
- 1 other product NDC are listed under this name. See all ZYRTEC Hives NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other ZYRTEC Hives products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zyrtec Hivescetirizine hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Kenvue Brands LLC | 50580-128 | 50580-0128-04 |
Other NDCs under NDA 019835
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 |
|---|---|---|---|---|
| Zyrtec Allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Kenvue Brands LLC | 50580-726 |
| Zyrtec Allergycetirizine hydrochloride | Cetirizine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Kenvue Brands LLC | 50580-754 |
| Zyrtec Allergycetirizine hydrochloride | — | Kit | Kenvue Brands LLC | 50580-752 |
| Zyrtec Allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | RedPharm Drug Inc | 67296-1484 |
| Zyrtec Allergy, Lil Drug Storecetirizine hydrochloride tablet, film coated | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Lil' Drug Store Products, Inc. | 66715-9811 |
| Zyrtec Allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Savings Distributors LLC | 73097-016 |
| Zyrtec Allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Morning Star OTC | 53209-5001 |
| Zyrtec Allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Navajo Manufacturing Company Incorporated | 67751-192 |
| Zyrtec Allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Select Consumer Group | 85237-2960 |