TRAMADOL HYDROCHLORIDE
- Product NDC
- 45865-900
- 11-digit product format
- 458650900
- Labeler code
- 45865
- Product ID
- 45865-900_7d6438eb-89e6-6171-e053-2991aa0aa8bc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TRAMADOL HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- medsource pharmaceuticals
- Application
- ANDA201384
- Marketing category
- ANDA
- Marketing start
- 2011-12-12
- 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
- 2020-12-31
- 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 |
|---|
| 45865-900-30 | 45865090030 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (45865-900-30) | 2018-06-01 | 0000-00-00 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| TRAMADOL HYDROCHLORIDE | medsource pharmaceuticals | 2018-12-19 | HUMAN PRESCRIPTION DRUG LABEL | 2 |