TRAMADOL HYDROCHLORIDE
- Product NDC
- 68071-5078
- 11-digit product format
- 680715078
- Labeler code
- 68071
- Product ID
- 68071-5078_1b466cdb-e4a9-9564-e063-6394a90add37
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TRAMADOL HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA200503
- Marketing category
- ANDA
- Marketing start
- 2014-08-18
- Substance
- TRAMADOL HYDROCHLORIDE
- Active strength
- 300 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 | Sample | Exclude flag | Status |
|---|
| 68071-5078-3 | 68071507803 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-5078-3) | 2019-10-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 2024-06-19 | HUMAN PRESCRIPTION DRUG LABEL | 3 |