ACETAMINOPHEN AND CODEINE PHOSPHATE
- Product NDC
- 68788-7802
- 11-digit product format
- 687887802
- Labeler code
- 68788
- Product ID
- 68788-7802_21edee0e-0650-4611-a345-a133a83f292a
- 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
- 2020-11-04
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; CODEINE PHOSPHATE
- Active strength
- 300 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-7802-1 | 68788780201 | 12 TABLET in 1 BOTTLE (68788-7802-1) | 12 tablet | 2020-11-04 | 0000-00-00 | No | No | Current |
| 68788-7802-2 | 68788780202 | 20 TABLET in 1 BOTTLE (68788-7802-2) | 20 tablet | 2020-11-04 | 0000-00-00 | No | No | Current |
| 68788-7802-3 | 68788780203 | 30 TABLET in 1 BOTTLE (68788-7802-3) | 30 tablet | 2020-11-04 | 0000-00-00 | No | No | Current |
| 68788-7802-6 | 68788780206 | 60 TABLET in 1 BOTTLE (68788-7802-6) | 60 tablet | 2020-11-04 | 0000-00-00 | No | No | Current |