Tramadol Hydrochloride
- Product NDC
- 80425-0276
- 11-digit product format
- 804250276
- Labeler code
- 80425
- Product ID
- 80425-0276_2a9bad62-b301-697c-e063-6294a90aa395
- 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
- 2023-02-17
- 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 |
|---|
| 80425-0276-1 | 80425027601 | 15 TABLET, COATED in 1 BOTTLE (80425-0276-1) | 2023-02-17 | No | No | Historical |
| 80425-0276-2 | 80425027602 | 30 TABLET, COATED in 1 BOTTLE (80425-0276-2) | 2023-02-17 | No | No | Historical |
| 80425-0276-3 | 80425027603 | 60 TABLET, COATED in 1 BOTTLE (80425-0276-3) | 2023-02-17 | No | No | Historical |
| 80425-0276-4 | 80425027604 | 90 TABLET, COATED in 1 BOTTLE (80425-0276-4) | 2023-02-17 | No | No | Historical |
| 80425-0276-5 | 80425027605 | 120 TABLET, COATED in 1 BOTTLE (80425-0276-5) | 2023-02-17 | No | No | Historical |
| 80425-0276-6 | 80425027606 | 40 TABLET, COATED in 1 BOTTLE (80425-0276-6) | 2023-02-17 | No | No | Historical |
| 80425-0276-7 | 80425027607 | 180 TABLET, COATED in 1 BOTTLE (80425-0276-7) | 2023-03-31 | No | No | Historical |
| 80425-0276-8 | 80425027608 | 240 TABLET, COATED in 1 BOTTLE (80425-0276-8) | 2023-03-31 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Tramadol Hydrochloride Tablets | Advanced Rx Pharmacy of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL | 3 |