Ibuprofen
- Product NDC
- 71610-916
- 11-digit product format
- 716100916
- Labeler code
- 71610
- Product ID
- 71610-916_388e68ec-5061-e4c0-e063-6394a90a35d4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA202413
- Marketing category
- ANDA
- Marketing start
- 2024-05-23
- 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 table| Ingredient | Strength |
|---|
| IBUPROFEN | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 197805 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-916-60 | Ibuprofen | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
| 71610-916-80 | Ibuprofen | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 1 |
| 71610-916-92 | Ibuprofen | 270 in 1 BOTTLE | TABLET, FILM COATED | 270 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-916-60 | 71610091660 | 90 TABLET, FILM COATED in 1 BOTTLE (71610-916-60) | 2025-06-24 | No | No | Historical |
| 71610-916-80 | 71610091680 | 180 TABLET, FILM COATED in 1 BOTTLE (71610-916-80) | 2025-06-24 | No | No | Historical |
| 71610-916-92 | 71610091692 | 270 TABLET, FILM COATED in 1 BOTTLE (71610-916-92) | 2025-06-24 | No | No | Historical |