Tramadol Hydrochloride
- Product NDC
- 60687-795
- 11-digit product format
- 606870795
- Labeler code
- 60687
- Product ID
- 60687-795_3d5c1244-dda1-8f70-e063-6394a90a4e38
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol Hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA076003
- Marketing category
- ANDA
- Marketing start
- 2024-01-20
- 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 |
|---|
| 60687-795-01 | Tramadol Hydrochloride | 100 in 1 CARTON | TABLET, COATED | 100 | | 3 |
| 60687-795-11 | Tramadol Hydrochloride | 1 in 1 BLISTER PACK | TABLET, COATED | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60687-795 | TRAMADOL HYDROCHLORIDE TABLET, COATED [AMERICAN HEALTH PACKAGING] | 2 | Current NDC, 2 package rows | 20240208_f6f6069b-cc75-4b87-afa5-b83001b543e0.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 |
|---|
| 60687-795-01 | 60687079501 | 100 BLISTER PACK in 1 CARTON (60687-795-01) / 1 TABLET, COATED in 1 BLISTER PACK (60687-795-11) | 100 blister pack | 2024-01-20 | No | No | Current |
| 60687-795-11 | 60687079511 | 1 in 1 BLISTER PACK | | | | | Historical |