Tramadol Hydrochloride
- Product NDC
- 58118-2348
- 11-digit product format
- 581182348
- Labeler code
- 58118
- Product ID
- 58118-2348_2d7afbeb-0877-e7df-e063-6394a90a2e55
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol Hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Clinical Solutions Wholesale, LLC
- Application
- ANDA076003
- Marketing category
- ANDA
- Marketing start
- 2023-02-13
- 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 |
|---|
| 58118-2348-8 | Tramadol Hydrochloride | 30 in 1 BLISTER PACK | TABLET, COATED | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58118-2348 | TRAMADOL HYDROCHLORIDE TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE, LLC] | 1 | Current NDC, 1 package rows | 20250209_728157e2-d153-4ea0-81eb-36599dc7dfda.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 58118-2348-8 | 58118234808 | 30 TABLET, COATED in 1 BLISTER PACK (58118-2348-8) | 2025-02-06 | No | No | Current |