Over-the-counter drug · ANDA
careone childrens allergy relief (Loratadine) NDC 41520-716
Loratadine 5 mg/1 · Tablet, Chewable · Oral · American Sales Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 41520-716-01 | 4152007160141520071601 | 20 BLISTER PACK in 1 CARTON (41520-716-01) / 1 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Jul 19, 2019 | |
| 41520-716-39 | 4152007163941520071639 | 30 BLISTER PACK in 1 CARTON (41520-716-39) / 1 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Jul 16, 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 childrens allergy relief
- Generic name (nonproprietary)
- loratadine
- Active ingredients
- Loratadine — 5 mg/1
- Dosage form
- Tablet, Chewable
- 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 210033
- Marketing start
- Listing expires
- Identifiers
- Product ID 41520-716_567de4c6-c106-4597-9e1a-f43fbb1592d6SPL ID 567de4c6-c106-4597-9e1a-f43fbb1592d6SPL set ID 06d1c443-ec23-4aa1-a7f3-f2b7ffcc2588RxCUI 665078UNII 7AJO3BO7QN
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
N441520071601followed by a unit qualifier and the quantityPackage 41520-0716-01. 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 • itchy, watery eyes • sneezing • itching of the nose or throat
Excerpt only. Read the full label for complete information.
About NDC 41520-716
- What is NDC 41520-716?
- 41520-716 is the product NDC for careone childrens allergy relief (loratadine), Loratadine 5 mg/1 tablet, chewable, listed with the FDA by American Sales Company. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- careone childrens allergy relief (Loratadine).
- What is the active ingredient?
- Loratadine.
- 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 childrens allergy relief?
- 4 other product NDCs are listed under this name. See all careone childrens 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 childrens 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 childrens allergy relieffluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | American Sales Company | 41520-553 | 41520-0553-02 |
| careone childrens allergy reliefcetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | American Sales Company | 41520-301 | 41520-0301-26 |
| careone childrens allergy reliefcetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | American Sales Company | 41520-902 | 41520-0902-26 |
| CareOne Childrens Allergy Reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | American Sales Company | 41520-632 | 41520-0632-26 |
Other NDCs under ANDA 210033
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 allergy reliefloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | Meijer Distribution Inc | 41250-629 |
| good sense childrens allergy reliefloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | L. Perrigo Company | 0113-1019 |
| dg health childrens allergy reliefloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | Dolgencorp, LLC | 55910-807 |
| Basic Care Childrens Allergy Reliefloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | Amazon.com Services LLC | 72288-901 |
| Berkley and Jensen Childrens Allergy Reliefloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | BJWC | 68391-301 |
| Childrens Allergy Reliefloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | H E B | 37808-506 |
| childrens allergy reliefloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | Amazon.com Services LLC | 72288-929 |
| childrens allergy reliefloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-133 |
| Equaline Childrens Allergy Reliefloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | United Natural Foods, Inc. dba UNFI | 41163-364 |
| Claritinloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | Bayer HealthCare LLC. | 11523-0104 |
| foster and thrive childrens allergy reliefloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | Strategic Sourcing Services LLC | 70677-1043 |
| childrens allergy reliefloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | Rite Aid Corporation | 11822-0801 |
| topcare childrens allergy reliefloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | Topco Associates LLC | 36800-363 |