Tramadol Hydrochloride
- Product NDC
- 0093-0058
- 11-digit product format
- 000930058
- Labeler code
- 0093
- Product ID
- 0093-0058_c74a886e-2684-4279-8c05-ad608245d856
- 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
- 2002-06-20
- Marketing end
- 0000-00-00
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TRAMADOL HYDROCHLORIDE | ACTIVE INGREDIENT | 9N7R477WCK | TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 8 | |
| TRAMADOL | ACTIVE MOIETY | 39J1LGJ30J | TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 8 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 8 | |
| HYPROMELLOSE 2910 (15 MPA.S) | INACTIVE INGREDIENT | 36SFW2JZ0W | TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 8 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 8 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 8 | |
| POLYETHYLENE GLYCOL 4000 | INACTIVE INGREDIENT | 4R4HFI6D95 | TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 8 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 8 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 8 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 8 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 8 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-0058 | TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] | 28 | Legacy NDC | 20240919_6d3b4049-2bfd-4874-b984-8fb231bff27c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0093-0058-01 | 00093005801 | 100 TABLET, FILM COATED in 1 BOTTLE (0093-0058-01) | 2002-06-20 | 0000-00-00 | No | No | Current |
| 0093-0058-05 | 00093005805 | 500 TABLET, FILM COATED in 1 BOTTLE (0093-0058-05) | 2002-07-03 | 0000-00-00 | No | No | Current |