TRAMADOL HYDROCHLORIDE
- Product NDC
- 68071-5078
- 11-digit product format
- 680715078
- Labeler code
- 68071
- Product ID
- 68071-5078_1b466cdb-e4a9-9564-e063-6394a90add37
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TRAMADOL HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA200503
- Marketing category
- ANDA
- Marketing start
- 2014-08-18
- 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
- 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 | 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 |
|---|
| 68071-5078-3 | TRAMADOL HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-5078 | TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [NUCARE PHARMACEUTICALS,INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240621_93e129c8-64c4-1f6d-e053-2a95a90ac1f8.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 |
|---|
| 68071-5078-3 | 68071507803 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-5078-3) | 2019-10-01 | 0000-00-00 | No | No | Current |