Acetaminophen and Codeine
- Product NDC
- 68071-3059
- 11-digit product format
- 680713059
- Labeler code
- 68071
- Product ID
- 68071-3059_4ab99175-62df-0584-e054-00144ff8d46c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acetaminophen and Codeine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCarePharmaceuticals, Inc.
- Application
- ANDA040779
- Marketing category
- ANDA
- Marketing start
- 2008-05-29
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record