Tramadol Hydrochloride
- Product NDC
- 59651-441
- 11-digit product format
- 596510441
- Labeler code
- 59651
- Product ID
- 59651-441_7100e3d0-b751-47a1-a947-97c7573eec7a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA203494
- Marketing category
- ANDA
- Marketing start
- 2020-09-23
- 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 |
|---|
| 59651-441-01 | Tramadol Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 14 |
| 59651-441-05 | Tramadol Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 14 |
| 59651-441-99 | Tramadol Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-441 | TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 10 | Current NDC, Legacy NDC, 3 package rows | 20240119_e5005d9e-91cb-4ff8-bcf2-b5ee70cf4f3f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 59651-441-01 | 59651044101 | 100 TABLET, FILM COATED in 1 BOTTLE (59651-441-01) | 2020-09-23 | 0000-00-00 | No | No | Current |
| 59651-441-05 | 59651044105 | 500 TABLET, FILM COATED in 1 BOTTLE (59651-441-05) | 2020-09-23 | 0000-00-00 | No | No | Current |
| 59651-441-19 | 59651044119 | 10000 TABLET, FILM COATED in 1 BAG (59651-441-19) | 23-SEP-20 | | | | Current |
| 59651-441-99 | 59651044199 | 1000 TABLET, FILM COATED in 1 BOTTLE (59651-441-99) | 2020-09-23 | 0000-00-00 | No | No | Current |