Tramadol Hydrochloride
- Product NDC
- 0093-3301
- 11-digit product format
- 000933301
- Labeler code
- 0093
- Product ID
- 0093-3301_502158c7-0bbc-4818-aa36-c6532bde9110
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA075977
- Marketing category
- ANDA
- Marketing start
- 2024-09-12
- 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
- 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 | 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 |
|---|
| 0093-3301-01 | Tramadol Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 6 |
| 0093-3301-05 | Tramadol Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-3301 | TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] | 4 | Current NDC, 2 package rows | 20240919_561f00e5-f69c-4369-ae4d-5eff86c4499f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0093-3301-01 | 00093330101 | 100 TABLET, FILM COATED in 1 BOTTLE (0093-3301-01) | 2024-09-17 | No | No | Current |
| 0093-3301-05 | 00093330105 | 500 TABLET, FILM COATED in 1 BOTTLE (0093-3301-05) | 2024-09-12 | No | No | Current |