Over-the-counter drug · ANDA
ZYRTEC Allergy (cetirizine hydrochloride) NDC 50580-786
Cetirizine hydrochloride 10 mg/1 · Capsule, Liquid filled · Oral · Kenvue Brands LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50580-786-12 | 50580078612 | 1 BOTTLE in 1 PACKAGE (50580-786-12) / 12 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Apr 15, 2024 | |
| 50580-786-13 | 50580078613 | 1 BOTTLE in 1 CARTON (50580-786-13) / 12 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Dec 1, 2024 | |
| 50580-786-25 | 50580078625 | 1 BOTTLE in 1 PACKAGE (50580-786-25) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Apr 15, 2024 | |
| 50580-786-26 | 50580078626 | 1 BOTTLE in 1 CARTON (50580-786-26) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Dec 1, 2024 | |
| 50580-786-40 | 50580078640 | 1 BOTTLE in 1 PACKAGE (50580-786-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Apr 15, 2024 | |
| 50580-786-41 | 50580078641 | 1 BOTTLE in 1 CARTON (50580-786-41) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Dec 1, 2024 | |
| 50580-786-65 | 50580078665 | 65 CAPSULE, LIQUID FILLED in 1 PACKAGE, COMBINATION (50580-786-65)Marketed from Apr 15, 2024 | |
| 50580-786-66 | 50580078666 | 65 CAPSULE, LIQUID FILLED in 1 PACKAGE (50580-786-66)Marketed from Dec 1, 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)
- ZYRTEC Allergy
- Generic name (nonproprietary)
- cetirizine hydrochloride
- Active ingredients
- Cetirizine hydrochloride — 10 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Kenvue Brands LLC
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213105
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 50580-786_41a5a9a1-61a6-f771-e063-6294a90aed87SPL ID 41a5a9a1-61a6-f771-e063-6294a90aed87SPL set ID 0face45c-af24-3559-e063-6294a90abde5RxCUI 1014675, 1020023UNII 64O047KTOAUPC 0300450204318
- 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
N450580078612followed by a unit qualifier and the quantityPackage 50580-0786-12. 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 ANDA 213105
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 |
|---|---|---|---|---|
| dg health all day allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Capsule, Liquid filledOral | Dolgencorp Inc | 55910-934 |
| Zyrtec Allergy Cetirizine HClcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | Jones Healthcare Group - Packaging Services, Inc | 67414-012 |
| Zyrtec Allergy Cetirizine HClcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | Jones Healthcare Group - Packaging Services, Inc | 67414-013 |
| Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | Capsule, Liquid filledOral | CVS PHARMACY, INC | 51316-811 |
| Good Sense All Day Allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Capsule, Liquid filledOral | L. Perrigo Company | 0113-0981 |
| careone allergy reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Capsule, Liquid filledOral | Retail Business Services, LLC | 72476-623 |
| allergy reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Capsule, Liquid filledOral | Publix Super Markets Inc | 56062-111 |
| Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | Capsule, Liquid filledOral | WALMART INC. (see also Equate) | 79903-347 |
| All Day Allergycetirizine hcl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | WALMART INC. (see also Equate) | 79903-084 |
| Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | H E B | 37808-564 |
| Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | CVS PHARMACY, INC | 51316-810 |
| basic care all day allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Capsule, Liquid filledOral | Amazon.com Services LLC | 72288-980 |
| All Day Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | P & L Development, LLC | 59726-064 |
| Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | CVS PHARMACY, INC | 51316-064 |
| Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | Safeway, Inc. | 21130-364 |
| Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | Care One (Retail Business Services, LLC.) | 72476-064 |
| topcare all day allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Capsule, Liquid filledOral | Topco Associates LLC | 36800-448 |