ACETAMINOPHEN AND CODEINE PHOSPHATE
- Product NDC
- 68788-8882
- 11-digit product format
- 687888882
- Labeler code
- 68788
- Product ID
- 68788-8882_7ab27392-9c6e-4ec3-85e7-06b43fcab3b1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- acetaminophen and codeine phosphate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA211610
- Marketing category
- ANDA
- Marketing start
- 2025-06-02
- 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
- 68788-8882_7ab27392-9c6e-4ec3-85e7-06b43fcab3b1
- 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
- 2025-06-02
- 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 | 7ab27392-9c6e-4ec3-85e7-06b43fcab3b1 |
| Manufacturer Name | Preferred Pharmaceuticals Inc. |
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 |
|---|
| 68788-8882-1 | 68788888201 | 15 TABLET in 1 BOTTLE (68788-8882-1) | 15 tablet | 2025-06-02 | No | No | Current |
| 68788-8882-3 | 68788888203 | 30 TABLET in 1 BOTTLE (68788-8882-3) | 30 tablet | 2025-06-02 | No | No | Current |
| 68788-8882-6 | 68788888206 | 60 TABLET in 1 BOTTLE (68788-8882-6) | 60 tablet | 2025-06-02 | No | No | Current |