Ibuprofen
- Product NDC
- 36800-993
- 11-digit product format
- 368000993
- Labeler code
- 36800
- Product ID
- 36800-993_15186c3d-7b83-47c0-9044-e90dc6ef0e2b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Topco Associates, LLC
- Application
- ANDA075139
- Marketing category
- ANDA
- Marketing start
- 1999-03-01
- 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 |
|---|
| 36800-993-06 | Ibuprofen | 200 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 200 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-993 | IBUPROFEN TABLET, FILM COATED [TOPCO ASSOCIATES, LLC] | 13 | Current NDC, Legacy NDC, 1 package rows | 20241113_bcf7d4c1-1f99-48df-8f74-9abeefa8d41d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 36800-993-06 | 36800099306 | 200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (36800-993-06) | 1999-03-01 | 0000-00-00 | No | No | Current |