ACETAMINOPHEN AND CODEINE PHOSPHATE
- Product NDC
- 63629-1190
- 11-digit product format
- 636291190
- Labeler code
- 63629
- Product ID
- 63629-1190_44718767-e131-4f39-879e-8628abe64d87
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- acetaminophen and codeine phosphate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA211610
- Marketing category
- ANDA
- Marketing start
- 2019-08-02
- 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
openFDA Listing Details
- Product ID
- 63629-1190_44718767-e131-4f39-879e-8628abe64d87
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- ACETAMINOPHEN AND CODEINE PHOSPHATE
- Generic name
- acetaminophen and codeine phosphate
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2019-08-02
- Marketing category
- ANDA
- Application number
- ANDA211610
- Pharmacologic classes
- Full Opioid Agonists [MoA]; Opioid Agonist [EPC]
- DEA schedule
- CIII
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 300 mg/1 |
| CODEINE PHOSPHATE | 60 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 362O9ITL9D, GSL05Y1MN6 |
| Rxcui | 993890 |
| Spl Set Id | ebdbc975-4e0e-4b83-8cf4-f29da829113a |
| Manufacturer Name | Bryant Ranch Prepack |
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 |
|---|
| 63629-1190-1 | 63629119001 | 500 TABLET in 1 BOTTLE (63629-1190-1) | 500 tablet | 2019-08-02 | 0000-00-00 | No | No | Current |