tramadol hydrochloride
- Product NDC
- 82868-052
- 11-digit product format
- 828680052
- Labeler code
- 82868
- Product ID
- 82868-052_46dcc3f7-cddf-bc73-e063-6294a90a5c9c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tramadol hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA202075
- Marketing category
- ANDA
- Marketing start
- 2024-06-04
- 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 |
|---|
| 82868-052-30 | tramadol hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82868-052 | TRAMADOL HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC] | 1 | Current NDC, 1 package rows | 20240627_1b5360f8-3e95-a047-e063-6294a90a7315.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 |
|---|
| 82868-052-30 | 82868005230 | 30 TABLET in 1 BOTTLE, PLASTIC (82868-052-30) | 30 tablet | 2024-06-04 | No | No | Historical |