ACETAMINOPHEN AND CODEINE PHOSPHATE
- Product NDC
- 68788-7801
- 11-digit product format
- 687887801
- Labeler code
- 68788
- Product ID
- 68788-7801_5b27316c-8343-4c59-bfc3-11e2ec27e2b3
- 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
- 2020-11-03
- 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 |
|---|
| 68788-7801-1 | 68788780101 | 15 TABLET in 1 BOTTLE (68788-7801-1) | 15 tablet | 2020-11-03 | 0000-00-00 | No | No | Current |
| 68788-7801-2 | 68788780102 | 20 TABLET in 1 BOTTLE (68788-7801-2) | 20 tablet | 2020-11-03 | 0000-00-00 | No | No | Current |
| 68788-7801-3 | 68788780103 | 30 TABLET in 1 BOTTLE (68788-7801-3) | 30 tablet | 2020-11-03 | 0000-00-00 | No | No | Current |
| 68788-7801-6 | 68788780106 | 60 TABLET in 1 BOTTLE (68788-7801-6) | 60 tablet | 2020-11-03 | 0000-00-00 | No | No | Current |