Ibuprofen
- Product NDC
- 50844-257
- 11-digit product format
- 508440257
- Labeler code
- 50844
- Product ID
- 50844-257_38225d8b-9f4a-4a4b-b4e4-3908bdb7a1a5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- L.N.K. International, Inc.
- Application
- ANDA075010
- Marketing category
- ANDA
- Marketing start
- 2019-07-22
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ibuprofen
- Listing expiration
- 2027-12-31
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 |
|---|
| 50844-257-15 | Ibuprofen | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 8 |
| 50844-257-15 | Ibuprofen | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50844-257 | IBUPROFEN TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] | 7 | Current NDC, Legacy NDC, 2 package rows | 20250418_0ef4913b-5dc3-45bc-9cef-58601f8d2a79.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50844-257-15 | 50844025715 | 1 BOTTLE in 1 CARTON (50844-257-15) / 50 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2019-07-22 | 0000-00-00 | No | No | Current |