Acetaminophen 250 mg and Ibuprofen 125 mg
- Product NDC
- 51672-4258
- 11-digit product format
- 516724258
- Labeler code
- 51672
- Product ID
- 51672-4258_4cb287fd-c316-032c-e063-6294a90a6ffe
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen 250 mg and Ibuprofen 125 mg Tablets
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA219053
- Marketing category
- ANDA
- Marketing start
- 2026-03-15
- Substance
- ACETAMINOPHEN; IBUPROFEN
- Active strength
- 250; 125 mg/1; 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
- Acetaminophen 250 mg and Ibuprofen 125 mg
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 250 mg/1 |
| IBUPROFEN | 125 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, WK2XYI10QM |
| Rxcui | 2387532 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51672-4258-1 | Acetaminophen 250 mg and Ibuprofen 125 mg | 1 in 1 CARTON | TABLET | 1 | | 4 |
| 51672-4258-1 | Acetaminophen 250 mg and Ibuprofen 125 mg | 216 in 1 BOTTLE | TABLET | 216 | | 4 |
| 51672-4258-4 | Acetaminophen 250 mg and Ibuprofen 125 mg | 1 in 1 CARTON | TABLET | 1 | | 4 |
| 51672-4258-4 | Acetaminophen 250 mg and Ibuprofen 125 mg | 72 in 1 BOTTLE | TABLET | 72 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 51672-4258-1 | 51672425801 | 1 BOTTLE in 1 CARTON (51672-4258-1) / 216 TABLET in 1 BOTTLE | 1 bottle | 2026-03-15 | No | No | Current |
| 51672-4258-4 | 51672425804 | 1 BOTTLE in 1 CARTON (51672-4258-4) / 72 TABLET in 1 BOTTLE | 1 bottle | 2026-03-15 | No | No | Current |