Over-the-counter drug · ANDA
Cetirizine (Cetiirizine) NDC 51316-764
Cetirizine hydrochloride 10 mg/1 · Tablet · Oral · CVS PHARMACY, INC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)51316-764Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51316-0764Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51316-764-65 | 5131607646551316076465 | 365 TABLET in 1 BOTTLE (51316-764-65)Marketed from Oct 16, 2023 |
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)
- Cetirizine
- Generic name (nonproprietary)
- cetiirizine
- Active ingredients
- Cetirizine hydrochloride — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- CVS PHARMACY, INCNDC labeler code 51316
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209274
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 51316-764_465428ca-3000-a730-e063-6394a90a1af4SPL ID 465428ca-3000-a730-e063-6394a90a1af4SPL set ID fd8f495a-9940-363b-e053-6294a90a1097RxCUI 1014678UNII 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
N451316076465followed by a unit qualifier and the quantityPackage 51316-0764-65. 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 51316-764
- What is NDC 51316-764?
- 51316-764 is the product NDC for Cetirizine (cetiirizine), Cetirizine hydrochloride 10 mg/1 tablet, listed with the FDA by CVS PHARMACY, INC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cetirizine (Cetiirizine).
- What is the active ingredient?
- Cetirizine hydrochloride.
- Who is the labeler?
- CVS PHARMACY, INC, NDC labeler code 51316. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cetirizine?
- 9 other product NDCs are listed under this name. See all Cetirizine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cetirizine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cetirizinecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0194 | 55154-0194-00 |
| Cetirizinecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | VERITYRX, LLC | 83939-0003 | 83939-0003-0083939-0003-0283939-0003-03 |
| Cetirizinecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7510 | 00904-7510-61 |
| Cetirizinecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-194 | 51655-0194-2651655-0194-5251655-0194-60 |
| Cetirizinecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6717 | 00904-6717-4000904-6717-4100904-6717-43+4 more |
| Cetirizinecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5510 | 50090-5510-0150090-5510-03 |
| Cetirizinecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7594 | 50090-7594-0050090-7594-01 |
| Cetirizinecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-123 | 71610-0123-60 |
| Cetirizinecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2162 | 72162-2162-0272162-2162-05 |
Other NDCs under ANDA 209274
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 |
|---|---|---|---|---|
| Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, CoatedOral | FSA STORE INC. | 81522-194 |
| Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | TabletOral | WinCo Foods, LLC | 67091-351 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Granules USA, Inc. | 69848-006 |
| Pentrexcilina Day timecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | OPMX LLC | 69729-137 |
| Cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | OPMX LLC | 69729-139 |
| Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, CoatedOral | MARC GLASSMAN, INC. | 68998-194 |
| Wal-Zyrcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | TabletOral | Walgreens | 0363-0606 |
| Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, CoatedOral | Amerifoods Trading Company | 61504-194 |
| CAREALL Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | TabletOral | New World Imports | 51824-104 |
| Cetirizine Hydrochloride 10 Mgcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | SDA Laboratories, Inc. | 66424-564 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | TWIN MED, LLC | 55681-073 |
| Cetirizine Hydrochloride 10 Mgcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | TWIN MED, LLC | 55681-302 |
| Curist Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, CoatedOral | Little Pharma, Inc. | 72559-003 |
| Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, CoatedOral | HARRIS TEETER | 72036-194 |
| Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | TabletOral | Camber Consumer Care | 69230-304 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | RETAIL BUSINESS SERVICES,LLC. | 72476-764 |
| Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Magno-Humphries, Inc. | 54257-270 |
| All Day Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | TabletOral | P & L Development, LLC | 59726-806 |
| Cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, CoatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8479 |
| Cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, CoatedOral | A-S Medication Solutions | 50090-6679 |
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