ACETAMINOPHEN AND CODEINE PHOSPHATE
- Product NDC
- 76420-821
- 11-digit product format
- 764200821
- Labeler code
- 76420
- Product ID
- 76420-821_3c8f10b4-0551-c65f-e063-6294a90a3543
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- acetaminophen and codeine phosphate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA211610
- Marketing category
- ANDA
- Marketing start
- 2019-08-02
- 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 |
|---|
| 76420-821-00 | 76420082100 | 100 TABLET in 1 BOTTLE (76420-821-00) | 100 tablet | 2024-07-01 | No | No | Historical |
| 76420-821-01 | 76420082101 | 1 TABLET in 1 BOTTLE (76420-821-01) | 1 tablet | 2024-07-01 | No | No | Historical |
| 76420-821-03 | 76420082103 | 3 TABLET in 1 BOTTLE (76420-821-03) | 3 tablet | 2024-07-01 | No | No | Historical |
| 76420-821-05 | 76420082105 | 5 TABLET in 1 BOTTLE (76420-821-05) | 5 tablet | 2024-07-01 | No | No | Historical |
| 76420-821-10 | 76420082110 | 10 TABLET in 1 BOTTLE (76420-821-10) | 10 tablet | 2024-07-01 | No | No | Historical |
| 76420-821-12 | 76420082112 | 12 TABLET in 1 BOTTLE (76420-821-12) | 12 tablet | 2024-07-01 | No | No | Historical |
| 76420-821-15 | 76420082115 | 15 TABLET in 1 BOTTLE (76420-821-15) | 15 tablet | 2024-07-01 | No | No | Historical |
| 76420-821-20 | 76420082120 | 20 TABLET in 1 BOTTLE (76420-821-20) | 20 tablet | 2024-07-01 | No | No | Historical |
| 76420-821-24 | 76420082124 | 24 TABLET in 1 BOTTLE (76420-821-24) | 24 tablet | 2025-08-17 | No | No | Historical |
| 76420-821-30 | 76420082130 | 30 TABLET in 1 BOTTLE (76420-821-30) | 30 tablet | 2024-07-01 | No | No | Historical |
| 76420-821-50 | 76420082150 | 500 TABLET in 1 BOTTLE (76420-821-50) | 500 tablet | 2024-07-01 | No | No | Historical |
| 76420-821-60 | 76420082160 | 60 TABLET in 1 BOTTLE (76420-821-60) | 60 tablet | 2024-07-01 | No | No | Historical |
| 76420-821-90 | 76420082190 | 90 TABLET in 1 BOTTLE (76420-821-90) | 90 tablet | 2024-07-01 | No | No | Historical |