Acetaminophen and Codeine Phosphate
- Product NDC
- 80425-0529
- 11-digit product format
- 804250529
- Labeler code
- 80425
- Product ID
- 80425-0529_3698e0ff-6a1d-e1ad-e063-6294a90a163a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acetaminophen and Codeine Phosphate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- ANDA212418
- Marketing category
- ANDA
- Marketing start
- 2025-06-02
- Substance
- ACETAMINOPHEN; CODEINE PHOSPHATE
- Active strength
- 300; 30 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 |
|---|
| 80425-0529-1 | 80425052901 | 30 TABLET in 1 BOTTLE (80425-0529-1) | 30 tablet | 2025-06-02 | No | No | Historical |
| 80425-0529-2 | 80425052902 | 60 TABLET in 1 BOTTLE (80425-0529-2) | 60 tablet | 2025-06-02 | No | No | Historical |
| 80425-0529-3 | 80425052903 | 90 TABLET in 1 BOTTLE (80425-0529-3) | 90 tablet | 2025-06-02 | No | No | Historical |