Tramadol Hydrochloride
- Product NDC
- 33358-342
- 11-digit product format
- 333580342
- Labeler code
- 33358
- Product ID
- 33358-342_6a61c7c9-ac81-463e-9872-0bfff0dbca95
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol Hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- RxChange Co.
- Application
- ANDA076003
- Marketing category
- ANDA
- Marketing start
- 2014-11-14
- 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
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 33358-342-00 | Tramadol Hydrochloride | 100 in 1 BOTTLE | TABLET, COATED | 100 | | 2 |
| 33358-342-60 | Tramadol Hydrochloride | 60 in 1 BOTTLE | TABLET, COATED | 60 | | 2 |
| 33358-342-90 | Tramadol Hydrochloride | 90 in 1 BOTTLE | TABLET, COATED | 90 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TRAMADOL HYDROCHLORIDE | ACTIVE INGREDIENT | 9N7R477WCK | TRAMADOL HYDROCHLORIDE TABLET, COATED [RXCHANGE CO.] | 2 | |
| TRAMADOL | ACTIVE MOIETY | 39J1LGJ30J | TRAMADOL HYDROCHLORIDE TABLET, COATED [RXCHANGE CO.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TRAMADOL HYDROCHLORIDE TABLET, COATED [RXCHANGE CO.] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | TRAMADOL HYDROCHLORIDE TABLET, COATED [RXCHANGE CO.] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | TRAMADOL HYDROCHLORIDE TABLET, COATED [RXCHANGE CO.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TRAMADOL HYDROCHLORIDE TABLET, COATED [RXCHANGE CO.] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | TRAMADOL HYDROCHLORIDE TABLET, COATED [RXCHANGE CO.] | 2 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | TRAMADOL HYDROCHLORIDE TABLET, COATED [RXCHANGE CO.] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | TRAMADOL HYDROCHLORIDE TABLET, COATED [RXCHANGE CO.] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | TRAMADOL HYDROCHLORIDE TABLET, COATED [RXCHANGE CO.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TRAMADOL HYDROCHLORIDE TABLET, COATED [RXCHANGE CO.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33358-342 | TRAMADOL HYDROCHLORIDE TABLET, COATED [RXCHANGE CO.] | 2 | Legacy NDC, 3 package rows | 20141201_19f1f780-9b4e-43a6-a758-9d7a3e5e4a60.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 33358-342-00 | 33358034200 | 100 in 1 BOTTLE | Historical |
| 33358-342-60 | 33358034260 | 60 in 1 BOTTLE | Historical |
| 33358-342-90 | 33358034290 | 90 in 1 BOTTLE | Historical |