NDC 43063-262

Pristiq Extended-Release

Desvenlafaxine Succinate

Pristiq Extended-Release is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, Inc.. The primary component is Desvenlafaxine Succinate.

• Product ID: 43063-262_80d9c462-e1a6-58cc-e053-2991aa0a164e
• NDC: 43063-262
• Product Type: Human Prescription Drug
• Proprietary Name: Pristiq Extended-Release
• Generic Name: Desvenlafaxine Succinate
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2008-05-01
• Marketing Category: NDA / NDA
• Application Number: NDA021992
• Labeler Name: PD-Rx Pharmaceuticals, Inc.
• Substance Name: DESVENLAFAXINE SUCCINATE
• Active Ingredient Strength: 50 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 43063-262-30

30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-262-30)

• Marketing Start Date: 2010-05-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43063-262-30 [43063026230]

Pristiq Extended-Release TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA021992
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-05-12

Drug Details

Active Ingredients

Ingredient	Strength
DESVENLAFAXINE SUCCINATE	50 mg/1

OpenFDA Data

• SPL SET ID: 2388423e-6f29-4da6-a34d-032a1e503488
• Manufacturer:
  • PD-Rx Pharmaceuticals, Inc.
• UNII:
  • ZB22ENF0XR
• RxNorm Concept Unique ID - RxCUI:
  • 1874559
  • 790290

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 "Pristiq Extended-Release" or generic name "Desvenlafaxine Succinate"

NDC	Brand Name	Generic Name
46708-540	Desvenlafaxine	Desvenlafaxine Succinate
46708-541	Desvenlafaxine	Desvenlafaxine Succinate
46708-542	Desvenlafaxine	Desvenlafaxine Succinate
50090-5274	Desvenlafaxine	Desvenlafaxine Succinate
50090-5293	Desvenlafaxine	Desvenlafaxine Succinate
51991-006	Desvenlafaxine	Desvenlafaxine Succinate
51991-311	Desvenlafaxine	Desvenlafaxine Succinate
51991-312	Desvenlafaxine	Desvenlafaxine Succinate
55700-577	Desvenlafaxine	Desvenlafaxine Succinate
50090-4069	Desvenlafaxine Succinate	desvenlafaxine succinate
59762-1210	Desvenlafaxine Succinate	desvenlafaxine succinate
0008-1210	Pristiq	desvenlafaxine succinate
0008-1211	Pristiq	desvenlafaxine succinate
0008-1222	Pristiq	desvenlafaxine succinate
35356-491	Pristiq	desvenlafaxine succinate
43063-262	Pristiq	desvenlafaxine succinate
55154-4230	Pristiq	desvenlafaxine succinate
55154-4235	Pristiq	desvenlafaxine succinate