Aacetaminophen and Ibuprofen
- Product NDC
- 69848-588
- 11-digit product format
- 698480588
- Labeler code
- 69848
- Product ID
- 69848-588_2a306431-7813-346e-e063-6294a90aca46
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen and Ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- GRANULES USA, INC.
- Application
- ANDA216592
- Marketing category
- ANDA
- Marketing start
- 2024-12-10
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Aacetaminophen and Ibuprofen
- Listing expiration
- 2026-12-31
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 |
|---|
| 69848-588-72 | Aacetaminophen and Ibuprofen | 72 in 1 BOTTLE | TABLET | 72 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 69848-588-72 | 69848058872 | 72 TABLET in 1 BOTTLE (69848-588-72) | 72 tablet | 2024-12-10 | No | No | Historical |