Topcare Dual Action Back Pain
- Product NDC
- 76162-520
- 11-digit product format
- 761620520
- Labeler code
- 76162
- Product ID
- 76162-520_8b9580f2-5be1-4484-a45a-b7eba1737134
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- ANDA214836
- Marketing category
- ANDA
- Marketing start
- 2024-01-31
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 362O9ITL9D | ACETAMINOPHEN | 103-90-2 | ACETAMINOPHEN |
| WK2XYI10QM | IBUPROFEN | 15687-27-1 | IBUPROFEN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76162-520-23 | 76162052023 | 1 BOTTLE in 1 CARTON (76162-520-23) / 72 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2024-01-31 | No | No | Historical |