Tramadol HCL
- Product NDC
- 80425-0312
- 11-digit product format
- 804250312
- Labeler code
- 80425
- Product ID
- 80425-0312_2a9bfe6a-6d6e-b262-e063-6294a90a1cf3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol HCL
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA200503
- Marketing category
- ANDA
- Marketing start
- 2023-04-07
- Substance
- TRAMADOL HYDROCHLORIDE
- Active strength
- 300 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tramadol HCL
- Brand name suffix
- ER
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TRAMADOL HYDROCHLORIDE | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9N7R477WCK |
| Rxcui | 833713 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80425-0312-1 | Tramadol HCLER | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 2 |
| 80425-0312-2 | Tramadol HCLER | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 2 |
| 80425-0312-3 | Tramadol HCLER | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0312 | TRAMADOL HCL ER (TRAMADOL HCL) TABLET, EXTENDED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 2 | Current NDC, 3 package rows | 20250102_f8c5328d-7b47-626e-e053-6294a90a04b3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0312-1 | 80425031201 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0312-1) | 2023-04-07 | No | No | Historical |
| 80425-0312-2 | 80425031202 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0312-2) | 2023-04-07 | No | No | Historical |
| 80425-0312-3 | 80425031203 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0312-3) | 2023-04-07 | No | No | Historical |