Ibuprofen
- Product NDC
- 80425-0553
- 11-digit product format
- 804250553
- Labeler code
- 80425
- Product ID
- 80425-0553_41351cd8-bc54-3906-e063-6294a90a3b83
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- ANDA202413
- Marketing category
- ANDA
- Marketing start
- 2025-10-15
- Substance
- IBUPROFEN
- Active strength
- 600 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 | 600 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 197806 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80425-0553-1 | Ibuprofen | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 80425-0553-2 | Ibuprofen | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
| 80425-0553-3 | Ibuprofen | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
| 80425-0553-4 | Ibuprofen | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0553-1 | 80425055301 | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0553-1) | 2025-10-15 | No | No | Historical |
| 80425-0553-2 | 80425055302 | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0553-2) | 2025-10-15 | No | No | Historical |
| 80425-0553-3 | 80425055303 | 90 TABLET, FILM COATED in 1 BOTTLE (80425-0553-3) | 2025-10-15 | No | No | Historical |
| 80425-0553-4 | 80425055304 | 100 TABLET, FILM COATED in 1 BOTTLE (80425-0553-4) | 2025-10-15 | No | No | Historical |