Acetaminophen and Ibuprofen
- Product NDC
- 0363-4081
- 11-digit product format
- 003634081
- Labeler code
- 0363
- Product ID
- 0363-4081_4618fbfc-8baf-e491-e063-6394a90ad817
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen and Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- WALGREEN COMPANY
- Application
- ANDA216999
- Marketing category
- ANDA
- Marketing start
- 2024-12-04
- 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
- Acetaminophen 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 |
|---|
| 0363-4081-78 | Acetaminophen and Ibuprofen | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 3 |
| 0363-4081-78 | Acetaminophen and Ibuprofen | 80 in 1 BOTTLE | TABLET, FILM COATED | 80 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0363-4081 | ACETAMINOPHEN AND IBUPROFEN TABLET, FILM COATED [WALGREEN COMPANY] | 2 | Current NDC, 2 package rows | 20241207_2789fdef-2d8e-6247-e063-6394a90a974b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0363-4081-78 | 00363408178 | 1 BOTTLE in 1 CARTON (0363-4081-78) / 80 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2024-12-04 | No | No | Current |