Ibuprofen
- Product NDC
- 36800-663
- 11-digit product format
- 368000663
- Labeler code
- 36800
- Product ID
- 36800-663_465211d9-ef70-2109-e063-6294a90ad3e2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- TOPCO ASSOCIATES LLC
- Application
- ANDA079174
- Marketing category
- ANDA
- Marketing start
- 2024-10-17
- Substance
- IBUPROFEN
- Active strength
- 200 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ibuprofen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IBUPROFEN | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 310965 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 36800-663-20 | Ibuprofen | 200 in 1 BOTTLE | TABLET | 200 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-663 | IBUPROFEN TABLET [TOPCO ASSOCIATES LLC] | 3 | Current NDC, 1 package rows | 20241120_1a00c17f-9766-deaa-e063-6394a90a8d60.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 36800-663-20 | 36800066320 | 200 TABLET in 1 BOTTLE (36800-663-20) | 200 tablet | 2024-10-17 | No | No | Current |