Acetaminophen and Codeine Phosphate
- Product NDC
- 68788-8881
- 11-digit product format
- 687888881
- Labeler code
- 68788
- Product ID
- 68788-8881_caa96b80-d8a7-4920-9d5c-717435e798de
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acetaminophen and Codeine Phosphate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA089828
- Marketing category
- ANDA
- Marketing start
- 2025-06-02
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Acetaminophen and Codeine Phosphate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 300 mg/1 |
| CODEINE PHOSPHATE | 60 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, GSL05Y1MN6 |
| Rxcui | 993890 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8881-1 | 68788888101 | 15 TABLET in 1 BOTTLE (68788-8881-1) | 15 tablet | 2025-06-02 | No | No | Historical |
| 68788-8881-3 | 68788888103 | 30 TABLET in 1 BOTTLE (68788-8881-3) | 30 tablet | 2025-06-02 | No | No | Historical |
| 68788-8881-6 | 68788888106 | 60 TABLET in 1 BOTTLE (68788-8881-6) | 60 tablet | 2025-06-02 | No | No | Historical |