Ibuprofen
- Product NDC
- 36800-286
- 11-digit product format
- 368000286
- Labeler code
- 36800
- Product ID
- 36800-286_ee297186-699a-dc48-e053-2995a90a266b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- TOPCO ASSOCIATES LLC
- Application
- ANDA202312
- Marketing category
- ANDA
- Marketing start
- 2021-11-01
- 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 |
|---|
| 36800-286-03 | Ibuprofen | 100 in 1 BOTTLE, PLASTIC | TABLET, COATED | 100 | | 2 |
| 36800-286-03 | Ibuprofen | 1 in 1 CARTON | TABLET, COATED | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-286 | IBUPROFEN TABLET, COATED [TOPCO ASSOCIATES LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20221124_cef74c2f-0c23-609d-e053-2a95a90a6b8e.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 |
|---|
| 36800-286-03 | 36800028603 | 1 BOTTLE, PLASTIC in 1 CARTON (36800-286-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC | 2021-11-01 | 0000-00-00 | No | No | Current |