Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 55700-823
- 11-digit product format
- 557000823
- Labeler code
- 55700
- Product ID
- 55700-823_b01de3c0-0c66-439e-9d3c-a07bf2081d75
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Quality Care Products, LLC
- Application
- ANDA211487
- Marketing category
- ANDA
- Marketing start
- 2019-11-27
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 325 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- DEA schedule
- CII
- 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 |
|---|
| 55700-823-01 | 55700082301 | 120 TABLET in 1 BOTTLE (55700-823-01) | 120 tablet | 2019-11-27 | 0000-00-00 | No | No | Current |
| 55700-823-30 | 55700082330 | 30 TABLET in 1 BOTTLE (55700-823-30) | 30 tablet | 2019-11-27 | 0000-00-00 | No | No | Current |
| 55700-823-60 | 55700082360 | 60 TABLET in 1 BOTTLE (55700-823-60) | 60 tablet | 2019-11-27 | 0000-00-00 | No | No | Current |
| 55700-823-90 | 55700082390 | 90 TABLET in 1 BOTTLE (55700-823-90) | 90 tablet | 2019-11-27 | 0000-00-00 | No | No | Current |