Over-the-counter drug · ANDA
topcare childrens allergy (Loratadine) NDC 36800-608
Loratadine 5 mg/5mL · Solution · Oral · Topco Associates LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-608-26 | 3680006082636800060826 | 1 BOTTLE in 1 CARTON (36800-608-26) / 120 mL in 1 BOTTLEMarketed from Jul 8, 2020 |
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
- Generic name (nonproprietary)
- loratadine
- Active ingredients
- Loratadine — 5 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Topco Associates LLCNDC labeler code 36800
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075728
- Marketing start
- Listing expires
- Identifiers
- Product ID 36800-608_3e49bf56-baef-4c33-a38b-a25794c15622SPL ID 3e49bf56-baef-4c33-a38b-a25794c15622SPL set ID 6e175fae-05dd-45c2-b9ab-7d49369a3c05RxCUI 692783UNII 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
N436800060826followed by a unit qualifier and the quantityPackage 36800-0608-26. 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 36800-608
- What is NDC 36800-608?
- 36800-608 is the product NDC for topcare childrens allergy (loratadine), Loratadine 5 mg/5mL solution, listed with the FDA by Topco Associates LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- topcare childrens allergy (Loratadine).
- What is the active ingredient?
- Loratadine.
- Who is the labeler?
- Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for topcare childrens allergy?
- 1 other product NDC are listed under this name. See all topcare childrens allergy NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other topcare childrens allergy products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Topcare childrens allergydiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | Topco Associates LLC | 36800-379 | 36800-0379-2636800-0379-34 |
Other NDCs under ANDA 075728
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/5mL | SolutionOral | Meijer, Inc. | 41250-716 |
| Good Sense childrens allergy reliefloratadine | Loratadine 5 mg/5mL | SolutionOral | Preferred Pharmaceuticals Inc. | 68788-8657 |
| Good Sense childrens allergy reliefloratadine | Loratadine 5 mg/5mL | SolutionOral | L. Perrigo Company | 0113-0671 |
| Childrens Loratadine Oralloratadine | Loratadine 5 mg/5mL | SolutionOral | Atlantic Biologicals | 17856-6767 |
| Childrens Allergy Reliefloratadine | Loratadine 5 mg/5mL | SolutionOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-611 |
| good neighbor pharmacy childrens loratadineloratadine | Loratadine 5 mg/5mL | SolutionOral | Amerisource Bergen | 46122-787 |
| leader childrens allergy reliefloratadine | Loratadine 5 mg/5mL | SolutionOral | Cardinal Health 110, LLC. dba Leader | 70000-0473 |
| equate childrens allergyloratadine | Loratadine 5 mg/5mL | SolutionOral | Wal-Mart Stores Inc | 49035-611 |
| Childrens Allergyloratadine | Loratadine 5 mg/5mL | SolutionOral | CVS Pharmacy | 69842-337 |
| childrens allergy reliefloratadine | Loratadine 5 mg/5mL | SolutionOral | Kroger Company | 30142-723 |
| Up And Up Childrens Allergyloratadine | Loratadine 5 mg/5mL | SolutionOral | Target Corporation | 82442-207 |
| Childrens Loratadine Oralloratadine | Loratadine 5 mg/5mL | SolutionOral | Major Pharmaceuticals | 0904-6767 |
| childrens allergy reliefloratadine | Loratadine 5 mg/5mL | SolutionOral | Rite Aid Corporation | 11822-0620 |
| Good Sense childrens allergy reliefloratadine | Loratadine 5 mg/5mL | SolutionOral | NuCare Pharmaceuticals,Inc. | 68071-3904 |
| Equaline Childrens Allergy Reliefloratadine | Loratadine 5 mg/5mL | SolutionOral | United Natural Foods, Inc. dba UNFI | 41163-633 |
| good sense childrens allergy reliefloratadine | Loratadine 5 mg/5mL | SolutionOral | L. Perrigo Company | 0113-1719 |
| basic care childrens allergy reliefloratadine | Loratadine 5 mg/5mL | SolutionOral | Amazon.com Services LLC | 72288-511 |
| welby childrens allergy reliefloratadine | Loratadine 5 mg/5mL | SolutionOral | Aldi Inc | 64024-023 |
| childrens allergy reliefloratadine | Loratadine 5 mg/5mL | SolutionOral | Amazon.com Services LLC | 72288-533 |
| dg health childrens allergyloratadine | Loratadine 5 mg/5mL | SolutionOral | Dolgencorp, LLC | 55910-611 |
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