HYDROCODONE BITARTRATE AND ACETAMINOPHEN
- Product NDC
- 42858-040
- 11-digit product format
- 428580040
- Labeler code
- 42858
- Product ID
- 42858-040_f6fca35d-725f-4d3a-93cd-604ee8b4c439
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROCODONE BITARTRATE and ACETAMINOPHEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rhodes Pharmaceuticals L.P.
- Application
- ANDA207808
- Marketing category
- ANDA
- Marketing start
- 2018-07-31
- Marketing end
- 0000-00-00
- Substance
- HYDROCODONE BITARTRATE; ACETAMINOPHEN
- Active strength
- 5 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC],Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 |
|---|
| 42858-040-01 | 42858004001 | 100 TABLET in 1 BOTTLE (42858-040-01) | 100 tablet | 2018-07-31 | 0000-00-00 | No | No | Current |
| 42858-040-50 | 42858004050 | 500 TABLET in 1 BOTTLE (42858-040-50) | 500 tablet | 2018-07-31 | 0000-00-00 | No | No | Current |