TRAMADOL HYDROCHLORIDE
- Product NDC
- 70518-2795
- 11-digit product format
- 705182795
- Labeler code
- 70518
- Product ID
- 70518-2795_4e412f24-05d3-b5a2-e063-6394a90adf5b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TRAMADOL HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA200503
- Marketing category
- ANDA
- Marketing start
- 2020-06-24
- 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
- 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 | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9N7R477WCK |
| Rxcui | 833713 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-2795-0 | TRAMADOL HYDROCHLORIDE | 30 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 30 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-2795 | TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.] | 8 | Current NDC, Legacy NDC, 1 package rows | 20250403_b76c1366-f6c0-42ad-bb19-2b72a91490e4.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 |
|---|
| 70518-2795-0 | 70518279500 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-2795-0) | 2020-06-24 | 0000-00-00 | No | No | Current |