TRAMADOL HYDROCHLORIDE
- Product NDC
- 45865-969
- 11-digit product format
- 458650969
- Labeler code
- 45865
- Product ID
- 45865-969_9af04fba-ba9e-3691-e053-2995a90a12e2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TRAMADOL HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- medsource pharmaceuticals
- Application
- ANDA200503
- Marketing category
- ANDA
- Marketing start
- 2014-08-19
- Marketing end
- 0000-00-00
- Substance
- TRAMADOL HYDROCHLORIDE
- Active strength
- 100 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 |
|---|
| 45865-969-30 | 45865096930 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (45865-969-30) | 2019-12-11 | 0000-00-00 | No | No | Current |
| 45865-969-60 | 45865096960 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (45865-969-60) | 2019-12-11 | 0000-00-00 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| TRAMADOL HYDROCHLORIDE | medsource pharmaceuticals | LUPIN LIMITED | 2019-12-30 | HUMAN PRESCRIPTION DRUG LABEL | 1 |