Over-the-counter drug · NDA
Zyrtec Hives (Cetirizine hydrochloride) NDC 50580-128
Cetirizine hydrochloride 1 mg/mL · Solution · Oral · Kenvue Brands LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50580-128-04 | 5058001280450580012804 | 1 BOTTLE in 1 CARTON (50580-128-04) / 118 mL in 1 BOTTLEMarketed from Apr 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 — 1 mg/mL
- Dosage form
- Solution
- 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 50580-128_37b3c47a-f31a-20f4-e063-6294a90ab07aSPL ID 37b3c47a-f31a-20f4-e063-6294a90ab07aSPL set ID 31400cb2-fe85-ef74-e063-6294a90a11fbRxCUI 1014673, 1020021UNII 64O047KTOAUPC 0300450139146
- 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
N450580012804followed by a unit qualifier and the quantityPackage 50580-0128-04. 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 50580-128
- What is NDC 50580-128?
- 50580-128 is the product NDC for Zyrtec Hives (cetirizine hydrochloride), Cetirizine hydrochloride 1 mg/mL solution, 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 10 mg/1 | Tablet, Film coatedOral | Kenvue Brands LLC | 50580-116 | 50580-0116-30 |
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 |
| Childrens Zyrtec Allergycetirizine hydrochloride | Cetirizine hydrochloride 5 mg/5mL | SyrupOral | Kenvue Brands LLC | 50580-721 |