TRAMADOL HYDROCHLORIDE
- Product NDC
- 68258-2003
- 11-digit product format
- 682582003
- Labeler code
- 68258
- Product ID
- 68258-2003_c8366081-d57b-4c2e-8000-d4c607d6029f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tramadol hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Dispensing Solutions, Inc.
- Application
- ANDA078783
- Marketing category
- ANDA
- Marketing start
- 2009-11-13
- Marketing end
- 0000-00-00
- Substance
- TRAMADOL HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- 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 |
|---|
| 68258-2003-3 | TRAMADOL HYDROCHLORIDE | 30 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 30 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TRAMADOL HYDROCHLORIDE | ACTIVE INGREDIENT | 9N7R477WCK | TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.] | 1 | |
| TRAMADOL | ACTIVE MOIETY | 39J1LGJ30J | TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.] | 1 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.] | 1 | |
| DIBUTYL SEBACATE | INACTIVE INGREDIENT | 4W5IH7FLNY | TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.] | 1 | |
| FERRIC OXIDE BLACK | INACTIVE INGREDIENT | XM0M87F357 | TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.] | 1 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.] | 1 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.] | 1 | |
| POVIDONE K90 | INACTIVE INGREDIENT | RDH86HJV5Z | TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68258-2003 | TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.] | 1 | Legacy NDC, 1 package rows | 20110930_f2bd24a1-01cd-461b-a330-0456a0e5ee58.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 68258-2003-3 | 68258200303 | 30 in 1 BOTTLE, PLASTIC | Historical |