IBUPROFEN
- Product NDC
- 71335-1517
- 11-digit product format
- 713351517
- Labeler code
- 71335
- Product ID
- 71335-1517_840d6421-5e3e-4933-84fb-e5676439b9a0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- IBUPROFEN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA090796
- Marketing category
- ANDA
- Marketing start
- 2015-12-30
- Substance
- IBUPROFEN
- Active strength
- 400 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 |
|---|
| IBUPROFEN | 400 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 197805, 197806, 197807 |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| WK2XYI10QM | IBUPROFEN | 15687-27-1 | IBUPROFEN |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71335-1517-1 | 71335151701 | 20 TABLET, FILM COATED in 1 BOTTLE (71335-1517-1) | 2020-02-20 | 0000-00-00 | No | No | Current |
| 71335-1517-2 | 71335151702 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1517-2) | 2020-02-20 | 0000-00-00 | No | No | Current |
| 71335-1517-3 | 71335151703 | 40 TABLET, FILM COATED in 1 BOTTLE (71335-1517-3) | 2020-02-20 | 0000-00-00 | No | No | Current |
| 71335-1517-4 | 71335151704 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1517-4) | 2020-02-20 | 0000-00-00 | No | No | Current |
| 71335-1517-5 | 71335151705 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1517-5) | 2020-02-20 | 0000-00-00 | No | No | Current |
| 71335-1517-6 | 71335151706 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1517-6) | 2020-02-20 | 0000-00-00 | No | No | Current |
| 71335-1517-7 | 71335151707 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1517-7) | 2020-02-20 | 0000-00-00 | No | No | Current |
| 71335-1517-8 | 71335151708 | 21 TABLET, FILM COATED in 1 BOTTLE (71335-1517-8) | 2020-02-20 | 0000-00-00 | No | No | Current |
| 71335-1517-9 | 71335151709 | 15 TABLET, FILM COATED in 1 BOTTLE (71335-1517-9) | 2020-02-20 | 0000-00-00 | No | No | Current |