Acetaminophen and Ibuprofen Back Pain
- Product NDC
- 70010-213
- 11-digit product format
- 700100213
- Labeler code
- 70010
- Product ID
- 70010-213_32562a4b-8df6-55fb-e063-6394a90ae483
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen and Ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Granules Pharmaceuticals Inc.
- Application
- ANDA216592
- Marketing category
- ANDA
- Marketing start
- 2023-07-14
- 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 Back Pain
- 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 |
|---|
| 70010-213-26 | Acetaminophen and Ibuprofen Back Pain | 1 in 1 CARTON | TABLET | 1 | | 1 |
| 70010-213-26 | Acetaminophen and Ibuprofen Back Pain | 18 in 1 BOTTLE | TABLET | 18 | | 1 |
| 70010-213-31 | Acetaminophen and Ibuprofen Back Pain | 288 in 1 BOTTLE | TABLET | 288 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70010-213 | ACETAMINOPHEN AND IBUPROFEN BACK PAIN (ACETAMINOPHEN AND IBUPROFEN) TABLET [GRANULES PHARMACEUTICALS INC.] | 1 | Current NDC, 3 package rows | 20250513_32562aa1-f44b-649e-e063-6394a90a47c8.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 |
|---|
| 70010-213-26 | 70010021326 | 1 BOTTLE in 1 CARTON (70010-213-26) / 18 TABLET in 1 BOTTLE | 1 bottle | 2023-07-14 | No | No | Current |
| 70010-213-31 | 70010021331 | 288 TABLET in 1 BOTTLE (70010-213-31) | 288 tablet | 2023-07-14 | No | No | Current |