ACETAMINOPHEN AND CODEINE PHOSPHATE
- Product NDC
- 63187-106
- 11-digit product format
- 631870106
- Labeler code
- 63187
- Product ID
- 63187-106_cd9e5061-9ddb-4d4b-a9d2-6509ea2c1e57
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- acetaminophen and codeine phosphate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA040419
- Marketing category
- ANDA
- Marketing start
- 2011-07-06
- 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 |
|---|
| 63187-106-15 | 63187010615 | 15 TABLET in 1 BOTTLE (63187-106-15) | 15 tablet | 2021-12-03 | No | No | Historical |
| 63187-106-20 | 63187010620 | 20 TABLET in 1 BOTTLE (63187-106-20) | 20 tablet | 2019-01-01 | No | No | Historical |
| 63187-106-30 | 63187010630 | 30 TABLET in 1 BOTTLE (63187-106-30) | 30 tablet | 2019-01-01 | No | No | Historical |