ACETAMINOPHEN AND CODEINE PHOSPHATE
- Product NDC
- 68071-2681
- 11-digit product format
- 680712681
- Labeler code
- 68071
- Product ID
- 68071-2681_2a33d462-6d0b-7d92-e063-6294a90a5c86
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- acetaminophen and codeine phosphate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA211610
- Marketing category
- ANDA
- Marketing start
- 2019-08-02
- Substance
- ACETAMINOPHEN; CODEINE PHOSPHATE
- Active strength
- 300; 60 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CIII
- 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 |
| GSL05Y1MN6 | CODEINE PHOSPHATE | 41444-62-6 | CODEINE PHOSPHATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-2681-6 | 68071268106 | 60 TABLET in 1 BOTTLE (68071-2681-6) | 60 tablet | 2022-04-28 | No | No | Historical |