Over-the-counter drug · ANDA
topcare childrens ibuprofen (Ibuprofen) NDC 36800-811
Ibuprofen 100 mg/1 · Tablet, Chewable · Oral · Topco Associates LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-811-62 | 3680008116236800081162 | 1 BOTTLE in 1 CARTON (36800-811-62) / 24 TABLET, CHEWABLE in 1 BOTTLEMarketed from Sep 4, 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)
- topcare childrens ibuprofen
- Generic name (nonproprietary)
- ibuprofen
- Active ingredients
- Ibuprofen — 100 mg/1
- Dosage form
- Tablet, Chewable
- 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 076359
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 36800-811_42eac10e-3ec4-4eaf-9e97-c50e2568430eSPL ID 42eac10e-3ec4-4eaf-9e97-c50e2568430eSPL set ID a88020c0-7982-4307-9836-74de66ea47a5RxCUI 310963UNII WK2XYI10QM
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
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
N436800081162followed by a unit qualifier and the quantityPackage 36800-0811-62. 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: • reduces fever • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
Excerpt only. Read the full label for complete information.
About NDC 36800-811
- What is NDC 36800-811?
- 36800-811 is the product NDC for topcare childrens ibuprofen (ibuprofen), Ibuprofen 100 mg/1 tablet, chewable, 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 ibuprofen (Ibuprofen).
- What is the active ingredient?
- Ibuprofen.
- 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 ibuprofen?
- 2 other product NDCs are listed under this name. See all topcare childrens ibuprofen 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 ibuprofen 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 ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Topco Associates LLC | 36800-166 | 36800-0166-26 |
| Topcare Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Topco Associates LLC | 36800-660 | 36800-0660-00 |
Other NDCs under ANDA 076359
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 |
|---|---|---|---|---|
| Good Sense Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/1 | Tablet, ChewableOral | L. Perrigo Company | 0113-7366 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/1 | Tablet, ChewableOral | Meijer, Inc. | 79481-0419 |
| Good Sense Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/1 | Tablet, ChewableOral | L. Perrigo Company | 0113-2461 |
| childrens ibuprofenibuprofen | Ibuprofen 100 mg/1 | Tablet, ChewableOral | Meijer Distribution Inc | 41250-331 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/1 | Tablet, ChewableOral | Amazon.com Services LLC | 72288-320 |
| childrens ibuprofenibuprofen | Ibuprofen 100 mg/1 | Tablet, ChewableOral | CVS Pharmacy | 69842-329 |
| childrens ibuprofenibuprofen | Ibuprofen 100 mg/1 | Tablet, ChewableOral | Safeway | 21130-790 |
| Up and Up Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/1 | Tablet, ChewableOral | Target Corporation | 11673-593 |
| good sense childrens ibuprofenibuprofen | Ibuprofen 100 mg/1 | Tablet, ChewableOral | L. Perrigo Company | 0113-6040 |
| childrens ibuprofenibuprofen | Ibuprofen 100 mg/1 | Tablet, ChewableOral | Kroger Company | 30142-402 |
| rexall ibuprofenibuprofen | Ibuprofen 100 mg/1 | Tablet, ChewableOral | Dolgencorp, LLC | 55910-521 |
| Basic Care Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/1 | Tablet, ChewableOral | Amazon.com Services LLC | 72288-461 |
| equaline childrens ibuprofenibuprofen | Ibuprofen 100 mg/1 | Tablet, ChewableOral | United Natural Foods, Inc. dba UNFI | 41163-710 |
| childrens ibuprofenibuprofen | Ibuprofen 100 mg/1 | Tablet, ChewableOral | Kroger Company | 30142-513 |
| childrens ibuprofen 100ibuprofen | Ibuprofen 100 mg/1 | Tablet, ChewableOral | Walgreen Company | 0363-1461 |
| basic care childrens ibuprofenibuprofen | Ibuprofen 100 mg/1 | Tablet, ChewableOral | Amazon.com Services LLC | 72288-521 |
| childrens ibuprofenibuprofen | Ibuprofen 100 mg/1 | Tablet, ChewableOral | CVS Pharmacy | 69842-521 |
| childrens ibuprofenibuprofen | Ibuprofen 100 mg/1 | Tablet, ChewableOral | Rite Aid Corporation | 11822-1521 |
| Good Neighbor Pharmacy Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/1 | Tablet, ChewableOral | Amerisource Bergen | 46122-617 |
| Up and Up Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/1 | Tablet, ChewableOral | Target Corporation | 11673-741 |
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