TRAMADOL HYDROCHLORIDE
- Product NDC
- 83008-009
- 11-digit product format
- 830080009
- Labeler code
- 83008
- Product ID
- 83008-009_6e6ef0b4-62eb-4258-af63-6ba7cbd023b6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TRAMADOL HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Quality Care Products, LLC
- Application
- ANDA200503
- Marketing category
- ANDA
- Marketing start
- 2023-03-03
- Marketing end
- 2027-01-31
- Substance
- TRAMADOL HYDROCHLORIDE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- 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 | Marketing end | Sample | Exclude flag | Status |
|---|
| 83008-009-30 | 83008000930 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (83008-009-30) | 2023-03-03 | 2027-01-31 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| TRAMADOL HYDROCHLORIDE | Quality Care Products, LLC | 2024-12-19 | HUMAN PRESCRIPTION DRUG LABEL | 3 |