Tramadol Hydrochloride
- Product NDC
- 80425-0274
- 11-digit product format
- 804250274
- Labeler code
- 80425
- Product ID
- 80425-0274_21b29899-296b-3c78-e063-6294a90a1e5a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol Hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA208708
- Marketing category
- ANDA
- Marketing start
- 2023-02-09
- Substance
- TRAMADOL HYDROCHLORIDE
- Active strength
- 50 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 |
|---|
| 80425-0274-1 | 80425027401 | 15 TABLET, COATED in 1 BOTTLE (80425-0274-1) | 2023-02-09 | No | No | Historical |
| 80425-0274-2 | 80425027402 | 30 TABLET, COATED in 1 BOTTLE (80425-0274-2) | 2023-02-09 | No | No | Historical |
| 80425-0274-3 | 80425027403 | 60 TABLET, COATED in 1 BOTTLE (80425-0274-3) | 2023-02-09 | No | No | Historical |
| 80425-0274-4 | 80425027404 | 90 TABLET, COATED in 1 BOTTLE (80425-0274-4) | 2023-02-09 | No | No | Historical |
| 80425-0274-5 | 80425027405 | 120 TABLET, COATED in 1 BOTTLE (80425-0274-5) | 2023-02-09 | No | No | Historical |
| 80425-0274-6 | 80425027406 | 40 TABLET, COATED in 1 BOTTLE (80425-0274-6) | 2023-02-09 | No | No | Historical |
| 80425-0274-7 | 80425027407 | 180 TABLET, COATED in 1 BOTTLE (80425-0274-7) | 2024-05-29 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Tramadol HCL 50mg Tablets | Advanced Rx Pharmacy of Tennessee, LLC | 2024-09-09 | HUMAN PRESCRIPTION DRUG LABEL | 3 |