NDC 0008-1222

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 Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc.. The primary component is Desvenlafaxine Succinate.

• Product ID: 0008-1222_0c40d9ea-730a-42d8-abd1-5a1da444dfb6
• NDC: 0008-1222
• 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: Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
• Substance Name: DESVENLAFAXINE SUCCINATE
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0008-1222-01

90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0008-1222-01)

• Marketing Start Date: 2008-05-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0008-1222-18 [00008122218]

Pristiq Extended-Release TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA021992
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-03-18
• Marketing End Date: 2015-03-25

NDC 0008-1222-01 [00008122201]

Pristiq Extended-Release TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA021992
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2008-05-01

NDC 0008-1222-30 [00008122230]

Pristiq Extended-Release TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA021992
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2008-05-01

NDC 0008-1222-14 [00008122214]

Pristiq Extended-Release TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA021992
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2008-05-01

NDC 0008-1222-50 [00008122250]

Pristiq Extended-Release TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA021992
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2008-05-01

NDC 0008-1222-17 [00008122217]

Pristiq Extended-Release TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA021992
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-03-18
• Marketing End Date: 2015-03-25

Drug Details

Active Ingredients

Ingredient	Strength
DESVENLAFAXINE SUCCINATE	100 mg/1

OpenFDA Data

• SPL SET ID: 0f43610c-f290-46ea-d186-4f998ed99fce
• Manufacturer:
  • Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
• UNII:
  • ZB22ENF0XR
• RxNorm Concept Unique ID - RxCUI:
  • 1874553
  • 1607619
  • 1607617
  • 1874559
  • 790267
  • 790290
• UPC Code:
  • 0300081211303
  • 0300081222309
  • 0300081210306

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