Over-the-counter drug · ANDA
CareOne Allergy Relief (Cetirizine hydrochloride) NDC 41520-781
Cetirizine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · American Sales Company
NDC codes
FDA NDC DirectoryProduct NDC (as listed)41520-781Labeler and product segments. Claims need a package NDC.
Product NDC at billing width41520-0781Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 41520-781-06 | 4152007810641520078106 | 1 BOTTLE in 1 CARTON (41520-781-06) / 70 TABLET, FILM COATED in 1 BOTTLEMarketed from Sep 29, 2016 | |
| 41520-781-39 | 4152007813941520078139 | 1 BOTTLE in 1 CARTON (41520-781-39) / 30 TABLET, FILM COATED in 1 BOTTLEMarketed from Sep 29, 2016 | |
| 41520-781-66 | 4152007816641520078166 | 14 BLISTER PACK in 1 CARTON (41520-781-66) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Sep 29, 2016 | |
| 41520-781-76 | 4152007817641520078176 | 1 BOTTLE in 1 CARTON (41520-781-76) / 120 TABLET, FILM COATED in 1 BOTTLEMarketed from Apr 12, 2019 |
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)
- CareOne Allergy Relief
- Generic name (nonproprietary)
- cetirizine hydrochloride
- Active ingredients
- Cetirizine hydrochloride — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- American Sales CompanyNDC labeler code 41520
- 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 41520-781_11e72e08-b407-4a84-a79e-1f14b987b1ecSPL ID 11e72e08-b407-4a84-a79e-1f14b987b1ecSPL set ID 533abfc1-226e-4a68-bfcc-ec046a4d5751RxCUI 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
N441520078106followed by a unit qualifier and the quantityPackage 41520-0781-06. 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 41520-781
- What is NDC 41520-781?
- 41520-781 is the product NDC for CareOne Allergy Relief (cetirizine hydrochloride), Cetirizine hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by American Sales Company. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- CareOne Allergy Relief (Cetirizine Hydrochloride).
- What is the active ingredient?
- Cetirizine hydrochloride.
- Who is the labeler?
- American Sales Company, NDC labeler code 41520. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for CareOne Allergy Relief?
- 7 other product NDCs are listed under this name. See all CareOne Allergy Relief NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other CareOne Allergy Relief products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| careone allergy reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Capsule, Liquid filledOral | Retail Business Services, LLC | 72476-623 | 72476-0623-63 |
| careone allergy relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | Retail Business Services, LLC | 72476-847 | 72476-0847-2272476-0847-95 |
| careone allergy reliefloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | American Sales Company | 41520-510 | 41520-0510-65 |
| CareOne Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Capsule, Liquid filledOral | American Sales Company | 41520-715 | 41520-0715-63 |
| careone allergy reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | American Sales Company | 41520-778 | 41520-0778-78 |
| CareOne Allergy Relieffexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | American Sales Company | 41520-229 | 41520-0229-2241520-0229-3941520-0229-95 |
| CareOne Allergy Relieffluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | American Sales Company | 41520-703 | 41520-0703-0141520-0703-0241520-0703-03 |
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 |
| Cetirizinecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-123 |
| 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 |
| 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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