Tramadol Hydrochloride
- Product NDC
- 64980-614
- 11-digit product format
- 649800614
- Labeler code
- 64980
- Product ID
- 64980-614_4a3ae814-06d8-4776-893b-db30c3d19ab6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA075968
- Marketing category
- ANDA
- Marketing start
- 2024-08-05
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tramadol Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TRAMADOL HYDROCHLORIDE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9N7R477WCK |
| Rxcui | 835603, 2179635 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64980-614-01 | Tramadol Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 4 |
| 64980-614-10 | Tramadol Hydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | | 4 |
| 64980-614-50 | Tramadol Hydrochloride | 500 in 1 BOTTLE | TABLET | 500 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64980-614 | TRAMADOL HYDROCHLORIDE TABLET [RISING PHARMA HOLDINGS, INC.] | 2 | Current NDC, 3 package rows | 20241028_b5852b90-e415-47ef-8f73-87266b58e033.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 |
|---|
| 64980-614-01 | 64980061401 | 100 TABLET in 1 BOTTLE (64980-614-01) | 100 tablet | 2024-08-05 | No | No | Current |
| 64980-614-10 | 64980061410 | 1000 TABLET in 1 BOTTLE (64980-614-10) | 1000 tablet | 2024-08-05 | No | No | Current |
| 64980-614-50 | 64980061450 | 500 TABLET in 1 BOTTLE (64980-614-50) | 500 tablet | 2024-08-05 | No | No | Current |