Tramadol Hydrochloride and Acetaminophen
- Product NDC
- 68084-825
- 11-digit product format
- 680840825
- Labeler code
- 68084
- Product ID
- 68084-825_e6da409e-52e2-70a2-e053-2a95a90af79a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol Hydrochloride and Acetaminophen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA077184
- Marketing category
- ANDA
- Marketing start
- 2014-08-05
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
- Active strength
- 325 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CIV
- 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 |
|---|
| 68084-825-01 | 68084082501 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-825-01) > 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-825-11) | 100 blister pack | 2014-08-05 | 0000-00-00 | No | No | Current |