Tramadol Hydrochloride
- Product NDC
- 68084-808
- 11-digit product format
- 680840808
- Labeler code
- 68084
- Product ID
- 68084-808_ea3fd61a-7ea4-388d-e053-2995a90a621e
- 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
- 2014-08-05
- 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
- 2023-12-31
- 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, COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| TRAMADOL | ACTIVE MOIETY | 39J1LGJ30J | TRAMADOL HYDROCHLORIDE TABLET, COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TRAMADOL HYDROCHLORIDE TABLET, COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | TRAMADOL HYDROCHLORIDE TABLET, COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | TRAMADOL HYDROCHLORIDE TABLET, COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TRAMADOL HYDROCHLORIDE TABLET, COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | TRAMADOL HYDROCHLORIDE TABLET, COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | TRAMADOL HYDROCHLORIDE TABLET, COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | TRAMADOL HYDROCHLORIDE TABLET, COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | TRAMADOL HYDROCHLORIDE TABLET, COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TRAMADOL HYDROCHLORIDE TABLET, COATED [AMERICAN HEALTH PACKAGING] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68084-808 | TRAMADOL HYDROCHLORIDE TABLET, COATED [AMERICAN HEALTH PACKAGING] | 9 | Legacy NDC | 20240310_9893b6c0-fe47-4e56-8857-d3a5a888b9fd.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68084-808-01 | 68084080801 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-808-01) > 1 TABLET, COATED in 1 BLISTER PACK (68084-808-11) | 100 blister pack | 2014-08-05 | 0000-00-00 | No | No | Current |