Over-the-counter drug · ANDA
Ibuprofen NDC 36800-662
Ibuprofen 200 mg/1 · Tablet · Oral · TOPCO ASSOCIATES LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-662-20 | 36800066220 | 200 TABLET in 1 BOTTLE (36800-662-20)Marketed from Oct 14, 2024 |
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)
- Ibuprofen
- Generic name (nonproprietary)
- ibuprofen
- Active ingredients
- Ibuprofen — 200 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- TOPCO ASSOCIATES LLC
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202312
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 36800-662_4652df48-b67b-3921-e063-6394a90adb21SPL ID 4652df48-b67b-3921-e063-6394a90adb21SPL set ID 1a00c85b-2ba5-32c3-e063-6294a90af148RxCUI 310965UNII 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
N436800066220followed by a unit qualifier and the quantityPackage 36800-0662-20. 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 minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps temporarily reduces fever
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202312
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 |
|---|---|---|---|---|
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Shield Pharmaceuticals Corp | 83059-0180 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | RETAIL BUSINESS SERVICES , LLC. | 72476-111 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | RETAIL BUSINESS SERVICES , LLC. | 72476-112 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | AAA Pharmaceutical, Inc. | 57344-811 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Shield Pharmaceuticals Corp | 83059-0082 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Demoulas Super Markets, Inc | 53942-112 |
| Assured Ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Spirit Pharmaceuticals LLC | 68210-4139 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Granules India Limited | 62207-320 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Granules India Limited | 62207-321 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | RETAIL BUSINESS SERVICES,LLC. | 72476-358 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | United Natural Foods, Inc. dba UNFI | 41163-116 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | HYVEE INC | 42507-865 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | VALU MERCHANDISERS COMPANY | 63941-111 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | DISCOUNT DRUG MART | 53943-111 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | DISCOUNT DRUG MART | 53943-112 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | United Natural Foods, Inc. dba UNFI | 41163-312 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Harris Teeter | 72036-211 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Harris Teeter | 72036-212 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Marc Glassman, Inc. | 68998-011 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | MARC GLASSMAN, INC. | 68998-012 |
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