Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 55700-598
- 11-digit product format
- 557000598
- Labeler code
- 55700
- Product ID
- 55700-598_8a8957ac-ad7a-4de3-9e28-70b68cf7652f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lake Erie Medical DBA Quality Care Products LLC
- Application
- ANDA209037
- Marketing category
- ANDA
- Marketing start
- 2018-04-13
- 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 |
|---|
| 55700-598-01 | 55700059801 | 120 TABLET in 1 BOTTLE (55700-598-01) | 120 tablet | 2018-04-13 | 0000-00-00 | No | No | Current |
| 55700-598-14 | 55700059814 | 14 TABLET in 1 BOTTLE (55700-598-14) | 14 tablet | 2018-04-13 | 0000-00-00 | No | No | Current |
| 55700-598-15 | 55700059815 | 15 TABLET in 1 BOTTLE (55700-598-15) | 15 tablet | 2018-04-13 | 0000-00-00 | No | No | Current |
| 55700-598-21 | 55700059821 | 21 TABLET in 1 BOTTLE (55700-598-21) | 21 tablet | 2018-04-13 | 0000-00-00 | No | No | Current |
| 55700-598-30 | 55700059830 | 30 TABLET in 1 BOTTLE (55700-598-30) | 30 tablet | 2018-04-13 | 0000-00-00 | No | No | Current |
| 55700-598-40 | 55700059840 | 40 TABLET in 1 BOTTLE (55700-598-40) | 40 tablet | 2020-02-21 | 0000-00-00 | No | No | Current |
| 55700-598-60 | 55700059860 | 60 TABLET in 1 BOTTLE (55700-598-60) | 60 tablet | 2018-04-13 | 0000-00-00 | No | No | Current |
| 55700-598-90 | 55700059890 | 90 TABLET in 1 BOTTLE (55700-598-90) | 90 tablet | 2018-04-13 | 0000-00-00 | No | No | Current |