NDC 65224-890
KHEDEZLA Extended-release
Desvenlafaxine
KHEDEZLA Extended-release is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Pernix Therapeutics. The primary component is Desvenlafaxine.
| Product ID | 65224-890_158a198b-948b-4ad9-a578-277ccc47d41c |
| NDC | 65224-890 |
| Product Type | Human Prescription Drug |
| Proprietary Name | KHEDEZLA Extended-release |
| Generic Name | Desvenlafaxine |
| Dosage Form | Tablet, Extended Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2013-07-10 |
| Marketing Category | NDA / NDA |
| Application Number | NDA204683 |
| Labeler Name | Pernix Therapeutics |
| Substance Name | DESVENLAFAXINE |
| Active Ingredient Strength | 100 mg/1 |
| Pharm Classes | Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 65224-890-31
30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (65224-890-31)
| Marketing Start Date | 2013-07-10 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 65224-890-31 [65224089031]
KHEDEZLA Extended-release TABLET, EXTENDED RELEASE
| Marketing Category | NDA |
| Application Number | NDA204683 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2013-07-10 |
| Marketing End Date | 2020-01-31 |
NDC 65224-890-90 [65224089090]
KHEDEZLA Extended-release TABLET, EXTENDED RELEASE
| Marketing Category | NDA |
| Application Number | NDA204683 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2013-07-10 |
| Marketing End Date | 2020-01-31 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| DESVENLAFAXINE | 100 mg/1 |
OpenFDA Data
| SPL SET ID: | 130b1f08-7b46-4f72-b3ff-03812687d8ce |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Norepinephrine Uptake Inhibitors [MoA]
- Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
- Serotonin Uptake Inhibitors [MoA]
- Cytochrome P450 2D6 Inhibitors [MoA]
NDC Crossover Matching brand name "KHEDEZLA Extended-release" or generic name "Desvenlafaxine"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 65224-880 | KHEDEZLA Extended-release | KHEDEZLA Extended-release |
| 65224-890 | KHEDEZLA Extended-release | KHEDEZLA Extended-release |
| 0054-0400 | Desvenlafaxine | Desvenlafaxine |
| 0054-0401 | Desvenlafaxine | Desvenlafaxine |
| 0054-0603 | Desvenlafaxine | Desvenlafaxine |
| 0378-4230 | Desvenlafaxine | desvenlafaxine |
| 0378-4231 | Desvenlafaxine | desvenlafaxine |
| 0591-3659 | Desvenlafaxine | Desvenlafaxine |
| 0591-3660 | Desvenlafaxine | Desvenlafaxine |
| 0591-4060 | Desvenlafaxine | Desvenlafaxine |
| 35208-009 | Desvenlafaxine | Desvenlafaxine |
| 35208-010 | Desvenlafaxine | Desvenlafaxine |
| 44183-880 | Desvenlafaxine | desvenlafaxine |
| 44183-890 | Desvenlafaxine | desvenlafaxine |
| 46708-152 | Desvenlafaxine | Desvenlafaxine |
| 46708-153 | Desvenlafaxine | Desvenlafaxine |
| 50090-4388 | Desvenlafaxine | Desvenlafaxine |
| 50090-4806 | Desvenlafaxine | Desvenlafaxine |
| 51407-021 | Desvenlafaxine | Desvenlafaxine |
| 51407-022 | Desvenlafaxine | Desvenlafaxine |
Trademark Results [KHEDEZLA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 KHEDEZLA 85814727 4692875 Live/Registered |
OSMOTICA COMMERCIAL AND SERVICES 2013-01-03 |
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