Tramadol Hydrochloride and Acetaminophen
- Product NDC
- 0378-8088
- 11-digit product format
- 003788088
- Labeler code
- 0378
- Product ID
- 0378-8088_8bc56d07-4c64-4931-a1d1-9a0396482e87
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tramadol hydrochloride and acetaminophen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA077858
- Marketing category
- ANDA
- Marketing start
- 2008-11-24
- Marketing end
- 2021-07-31
- Substance
- TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN
- Active strength
- 38 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-8088-01 | 00378808801 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-8088-01) | 2008-11-24 | 0000-00-00 | No | No | Current |
| 0378-8088-05 | 00378808805 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-8088-05) | 2008-11-24 | 0000-00-00 | No | No | Current |