TRAMADOL HYDROCHLORIDE
- Product NDC
- 70518-3386
- 11-digit product format
- 705183386
- Labeler code
- 70518
- Product ID
- 70518-3386_da2d65bb-c7d3-180d-e053-2995a90a04f7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TRAMADOL HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA201384
- Marketing category
- ANDA
- Marketing start
- 2022-03-11
- Marketing end
- 0000-00-00
- Substance
- TRAMADOL HYDROCHLORIDE
- Active strength
- 200 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 9N7R477WCK | TRAMADOL HYDROCHLORIDE | 36282-47-0 | TRAMADOL HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-3386-0 | 70518338600 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-3386-0) | 2022-03-11 | 0000-00-00 | No | No | Current |