ULTRAM
- Product NDC
- 50458-659
- 11-digit product format
- 504580659
- Labeler code
- 50458
- Product ID
- 50458-659_573482f4-b6a3-11ec-b822-b84b65fc2800
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tramadol hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Janssen Pharmaceuticals, Inc.
- Application
- NDA020281
- Marketing category
- NDA
- Marketing start
- 1995-03-03
- Marketing end
- 2040-09-30
- 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 table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50458-659-60 | 50458065960 | 100 TABLET, COATED in 1 BOTTLE (50458-659-60) | 1995-03-03 | 0000-00-00 | No | No | Current |