Acetaminophen and Codeine Phosphate
- Product NDC
- 63187-291
- 11-digit product format
- 631870291
- Labeler code
- 63187
- Product ID
- 63187-291_4a2943a5-d06e-489a-9d56-682712ca8a7e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ACETAMINOPHEN and CODEINE PHOSPHATE
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA087508
- Marketing category
- ANDA
- Marketing start
- 1981-08-21
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; CODEINE PHOSPHATE
- Active strength
- 120 mg/5mL; mg/5mL
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
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 | Marketing end | Sample | Exclude flag | Status |
|---|
| 63187-291-04 | 63187029104 | 118 mL in 1 BOTTLE (63187-291-04) | 118 ml | 2019-01-01 | 0000-00-00 | No | No | Current |