Over-the-counter drug · ANDA
Cetirizine (Cetirizine hydrochloride) NDC 71610-123
Cetirizine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)71610-123Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71610-0123Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-123-60 | 7161001236071610012360 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-123-60)Marketed from Aug 17, 2018 |
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)
- cetirizine hydrochloride
- Active ingredients
- Cetirizine hydrochloride — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078336
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 71610-123_4528b1ee-ac82-2b33-e063-6294a90a599aSPL ID 4528b1ee-ac82-2b33-e063-6294a90a599aSPL set ID 4a45672b-67d3-4739-86ec-0a6696dd83d4RxCUI 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
N471610012360followed by a unit qualifier and the quantityPackage 71610-0123-60. 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 71610-123
- What is NDC 71610-123?
- 71610-123 is the product NDC for Cetirizine (cetirizine hydrochloride), Cetirizine hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cetirizine (Cetirizine Hydrochloride).
- What is the active ingredient?
- Cetirizine hydrochloride.
- Who is the labeler?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 |
| Cetirizinecetiirizine | Cetirizine hydrochloride 10 mg/1 | TabletOral | CVS PHARMACY, INC | 51316-764 | 51316-0764-65 |
| 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 | Bryant Ranch Prepack | 72162-2162 | 72162-2162-0272162-2162-05 |
Other NDCs under ANDA 078336
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 |
|---|---|---|---|---|
| Goodnow Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Gobrands, Inc | 82501-0422 |
| Cetirizinecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0194 |
| allergy reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Safeway | 21130-425 |
| rexall all day allergy reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Dolgencorp, LLC | 55910-699 |
| All Day Allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | HyVee Inc | 42507-458 |
| cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-862 |
| good neighbor pharmacy all day allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Amerisource Bergen | 24385-998 |
| cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-343 |
| TopCare All Day Allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Topco Associates LLC | 36800-458 |
| Cetirizinecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7594 |
| equate allergy reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Wal-Mart Stores Inc | 49035-458 |
| leader all day allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Cardinal Health 110, LLC. dba Leader | 70000-0380 |
| cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Padagis Israel Pharmaceuticals Ltd | 45802-919 |
| CareOne Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | American Sales Company | 41520-781 |
| cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Proficient Rx LP | 71205-207 |
| Up and Up Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Target Corporation | 11673-502 |
| Exchange select all day allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Army & Air Force Exchange Service | 55301-076 |
| Good Sense all day allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7064 |
| Good Sense all day allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7065 |
| Members Mark Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Sam's West Inc | 68196-413 |
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