Acetaminophen and Codeine
- Product NDC
- 76420-103
- 11-digit product format
- 764200103
- Labeler code
- 76420
- Product ID
- 76420-103_b2dde53b-af58-ce44-e053-2a95a90a8fe0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acetaminophen and Codeine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA040779
- Marketing category
- ANDA
- Marketing start
- 2008-05-29
- 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 |
|---|
| 76420-103-03 | 76420010303 | 3 TABLET in 1 BOTTLE (76420-103-03) | 3 tablet | 2020-10-30 | No | No | Historical |
| 76420-103-10 | 76420010310 | 10 TABLET in 1 BOTTLE (76420-103-10) | 10 tablet | 2020-10-30 | No | No | Historical |
| 76420-103-20 | 76420010320 | 20 TABLET in 1 BOTTLE (76420-103-20) | 20 tablet | 2020-10-30 | No | No | Historical |
| 76420-103-30 | 76420010330 | 30 TABLET in 1 BOTTLE (76420-103-30) | 30 tablet | 2020-10-30 | No | No | Historical |