Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 68084-895
- 11-digit product format
- 680840895
- Labeler code
- 68084
- Product ID
- 68084-895_ec1b9572-c304-271c-e053-2a95a90a16f6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA040736
- Marketing category
- ANDA
- Marketing start
- 2014-09-26
- 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 |
|---|
| 68084-895-01 | 68084089501 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-895-01) > 1 TABLET in 1 BLISTER PACK (68084-895-11) | 100 blister pack | 2015-02-25 | 0000-00-00 | No | No | Current |
| 68084-895-09 | 68084089509 | 80 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-895-09) > 1 TABLET in 1 BLISTER PACK (68084-895-11) | 80 blister pack | 2014-09-26 | 0000-00-00 | No | No | Current |