Tramadol Hydrochloride
- Product NDC
- 0378-4151
- 11-digit product format
- 003784151
- Labeler code
- 0378
- Product ID
- 0378-4151_4d69cadb-219a-4f9b-8823-337a83fab981
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tramadol hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA075986
- Marketing category
- ANDA
- Marketing start
- 2002-06-21
- Marketing end
- 2022-08-31
- Substance
- TRAMADOL HYDROCHLORIDE
- Active strength
- 50 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 | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0378-4151-01 | 00378415101 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4151-01) | 2002-06-21 | 0000-00-00 | No | No | Current |
| 0378-4151-05 | 00378415105 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4151-05) | 2002-06-21 | 0000-00-00 | No | No | Current |