tramadol hydrochloride
- Product NDC
- 70518-4248
- 11-digit product format
- 705184248
- Labeler code
- 70518
- Product ID
- 70518-4248_4007fbf6-8ef0-85e9-e063-6394a90a4013
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tramadol hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA202075
- Marketing category
- ANDA
- Marketing start
- 2024-12-30
- 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 |
|---|
| 70518-4248-0 | tramadol hydrochloride | 30 in 1 BLISTER PACK | TABLET | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4248 | TRAMADOL HYDROCHLORIDE TABLET [REMEDYREPACK INC.] | 1 | Current NDC, 1 package rows | 20250101_c6104e62-5b2c-41a1-afb3-00dcf267a384.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 |
|---|
| 70518-4248-0 | 70518424800 | 30 TABLET in 1 BLISTER PACK (70518-4248-0) | 30 tablet | 2024-12-30 | No | No | Current |