Over-the-counter drug · ANDA
topcare childrens allergy relief (loratadine) NDC 36800-363
Loratadine 5 mg/1 · Tablet, Chewable · Oral · Topco Associates LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-363-39 | 36800036339 | 30 BLISTER PACK in 1 CARTON (36800-363-39) / 1 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Sep 20, 2019 | |
| 36800-363-49 | 36800036349 | 40 BLISTER PACK in 1 CARTON (36800-363-49) / 1 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Jun 20, 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)
- topcare childrens allergy relief
- Generic name (nonproprietary)
- loratadine
- Active ingredients
- Loratadine — 5 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Labeler
- Topco Associates LLC
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210033
- Marketing start
- Listing expires
- Identifiers
- Product ID 36800-363_d6a8c36e-4c50-4c16-96a0-2b056a050e17SPL ID d6a8c36e-4c50-4c16-96a0-2b056a050e17SPL set ID 4f7555ea-6286-4ff6-b125-d12660ae4bdfRxCUI 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
N436800036339followed by a unit qualifier and the quantityPackage 36800-0363-39. 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.
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 |
|---|---|---|---|---|
| foster and thrive childrens allergy reliefloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | Strategic Sourcing Services LLC | 70677-1043 |
| careone childrens allergy reliefloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | American Sales Company | 41520-716 |
| Childrens Allergy Reliefloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | H E B | 37808-506 |
| good sense childrens allergy reliefloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | L. Perrigo Company | 0113-1019 |
| Equaline Childrens Allergy Reliefloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | United Natural Foods, Inc. dba UNFI | 41163-364 |
| Basic Care Childrens Allergy Reliefloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | Amazon.com Services LLC | 72288-901 |
| childrens allergy reliefloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | Rite Aid Corporation | 11822-0801 |
| Claritinloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | Bayer HealthCare LLC. | 11523-0104 |
| dg health childrens allergy reliefloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | Dolgencorp, LLC | 55910-807 |
| Berkley and Jensen Childrens Allergy Reliefloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | BJWC | 68391-301 |
| childrens allergy reliefloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | Meijer Distribution Inc | 41250-629 |
| childrens allergy reliefloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-133 |