HYDROCODONE BITARTRATE and ACETAMINOPHEN
- Product NDC
- 69101-600
- 11-digit product format
- 691010600
- Labeler code
- 69101
- Product ID
- 69101-600_96b0c532-b1a7-f6c5-e053-2a95a90a4af2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROCODONE BITARTRATE and ACETAMINOPHEN
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Burke Therapeutics, LLC
- Application
- ANDA040834
- Marketing category
- ANDA
- Marketing start
- 2015-03-18
- Marketing end
- 0000-00-00
- Substance
- HYDROCODONE BITARTRATE; ACETAMINOPHEN
- Active strength
- 10 mg/15mL; mg/15mL
- Pharmacologic classes
- Opioid Agonist [EPC],Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69101-600-08 | 69101060008 | 8 CUP, UNIT-DOSE in 1 TRAY (69101-600-08) > 15 mL in 1 CUP, UNIT-DOSE (69101-600-15) | 2018-11-08 | 0000-00-00 | No | No | Current |