Tramadol Hydrochloride
- Product NDC
- 0904-7496
- 11-digit product format
- 009047496
- Labeler code
- 0904
- Product ID
- 0904-7496_82c494ed-bc8b-45f5-a26d-5e4660f79feb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol Hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA076003
- Marketing category
- ANDA
- Marketing start
- 2024-11-22
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tramadol Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TRAMADOL HYDROCHLORIDE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9N7R477WCK |
| Rxcui | 835603 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-7496-61 | Tramadol Hydrochloride | 1 in 1 BLISTER PACK | TABLET, COATED | 1 | | 4 |
| 0904-7496-61 | Tramadol Hydrochloride | 100 in 1 CARTON | TABLET, COATED | 100 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7496 | TRAMADOL HYDROCHLORIDE TABLET, COATED [MAJOR PHARMACEUTICALS] | 3 | Current NDC, 2 package rows | 20250224_6b0b95b2-ae4c-42e8-9f2e-bcdaffda62e2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0904-7496-61 | 00904749661 | 100 BLISTER PACK in 1 CARTON (0904-7496-61) / 1 TABLET, COATED in 1 BLISTER PACK | 100 blister pack | 2024-11-22 | No | No | Current |