pristiq extended-release

Generic: desvenlafaxine succinate

Labeler: wyeth pharmaceuticals llc, a subsidiary of pfizer inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name pristiq extended-release
Generic Name desvenlafaxine succinate
Labeler wyeth pharmaceuticals llc, a subsidiary of pfizer inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

desvenlafaxine succinate 50 mg/1

Manufacturer
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

Identifiers & Regulatory

Product NDC 0008-1211
Product ID 0008-1211_1bdeb7f1-3871-48b2-9fa9-7fdb714faf3f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021992
Listing Expiration 2026-12-31
Marketing Start 2008-05-01

Pharmacologic Class

Classes
cytochrome p450 2d6 inhibitors [moa] norepinephrine uptake inhibitors [moa] serotonin uptake inhibitors [moa] serotonin and norepinephrine reuptake inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00081211
Hyphenated Format 0008-1211

Supplemental Identifiers

RxCUI
790267 790290 1607617 1607619 1874553 1874559
UPC
0300081210306 0300081222309 0300081211303
UNII
ZB22ENF0XR

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name pristiq extended-release (source: ndc)
Generic Name desvenlafaxine succinate (source: ndc)
Application Number NDA021992 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0008-1211-01)
  • 14 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0008-1211-14)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0008-1211-30)
  • 100 BLISTER PACK in 1 CARTON (0008-1211-50) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (4)

0008-1211-01 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0008-1211-01) 0008-1211-14 14 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0008-1211-14) 0008-1211-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0008-1211-30) 0008-1211-50 100 BLISTER PACK in 1 CARTON (0008-1211-50) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (1)

desvenlafaxine succinate (50 mg/1)

Linked Drug Pages (1)

Pristiq Extended-Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1bdeb7f1-3871-48b2-9fa9-7fdb714faf3f", "openfda": {"upc": ["0300081210306", "0300081222309", "0300081211303"], "unii": ["ZB22ENF0XR"], "rxcui": ["790267", "790290", "1607617", "1607619", "1874553", "1874559"], "spl_set_id": ["0f43610c-f290-46ea-d186-4f998ed99fce"], "manufacturer_name": ["Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0008-1211-01)", "package_ndc": "0008-1211-01", "marketing_start_date": "20080501"}, {"sample": false, "description": "14 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0008-1211-14)", "package_ndc": "0008-1211-14", "marketing_start_date": "20080501"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0008-1211-30)", "package_ndc": "0008-1211-30", "marketing_start_date": "20080501"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0008-1211-50)  / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "0008-1211-50", "marketing_start_date": "20080501"}], "brand_name": "Pristiq Extended-Release", "product_id": "0008-1211_1bdeb7f1-3871-48b2-9fa9-7fdb714faf3f", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "0008-1211", "generic_name": "desvenlafaxine succinate", "labeler_name": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pristiq", "brand_name_suffix": "Extended-Release", "active_ingredients": [{"name": "DESVENLAFAXINE SUCCINATE", "strength": "50 mg/1"}], "application_number": "NDA021992", "marketing_category": "NDA", "marketing_start_date": "20080501", "listing_expiration_date": "20261231"}