desvenlafaxine

Generic: desvenlafaxine succinate

Labeler: breckenridge pharmaceutical, inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name desvenlafaxine
Generic Name desvenlafaxine succinate
Labeler breckenridge pharmaceutical, inc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

desvenlafaxine succinate 100 mg/1

Manufacturer
Breckenridge Pharmaceutical, Inc

Identifiers & Regulatory

Product NDC 51991-312
Product ID 51991-312_34b890a1-3d88-43fb-b54b-f168ae22ebc7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204003
Listing Expiration 2026-12-31
Marketing Start 2017-03-01

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 51991312
Hyphenated Format 51991-312

Supplemental Identifiers

RxCUI
1607617 1874553 1874559
UPC
0351991006336
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 desvenlafaxine (source: ndc)
Generic Name desvenlafaxine succinate (source: ndc)
Application Number ANDA204003 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-312-01)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-312-10)
  • 100 TABLET, EXTENDED RELEASE in 1 CARTON (51991-312-11)
  • 14 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-312-14)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-312-33)
  • 80 TABLET, EXTENDED RELEASE in 1 CARTON (51991-312-80)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-312-90)
source: ndc

Packages (7)

51991-312-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-312-01) 51991-312-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-312-10) 51991-312-11 100 TABLET, EXTENDED RELEASE in 1 CARTON (51991-312-11) 51991-312-14 14 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-312-14) 51991-312-33 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-312-33) 51991-312-80 80 TABLET, EXTENDED RELEASE in 1 CARTON (51991-312-80) 51991-312-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-312-90)

Ingredients (1)

desvenlafaxine succinate (100 mg/1)

Linked Drug Pages (1)

Desvenlafaxine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "34b890a1-3d88-43fb-b54b-f168ae22ebc7", "openfda": {"upc": ["0351991006336"], "unii": ["ZB22ENF0XR"], "rxcui": ["1607617", "1874553", "1874559"], "spl_set_id": ["25bdfc41-c7cb-4d16-b6a8-f102f9b8c984"], "manufacturer_name": ["Breckenridge Pharmaceutical, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-312-01)", "package_ndc": "51991-312-01", "marketing_start_date": "20170301"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-312-10)", "package_ndc": "51991-312-10", "marketing_start_date": "20170301"}, {"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 CARTON (51991-312-11)", "package_ndc": "51991-312-11", "marketing_start_date": "20170301"}, {"sample": false, "description": "14 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-312-14)", "package_ndc": "51991-312-14", "marketing_start_date": "20170301"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-312-33)", "package_ndc": "51991-312-33", "marketing_start_date": "20170301"}, {"sample": false, "description": "80 TABLET, EXTENDED RELEASE in 1 CARTON (51991-312-80)", "package_ndc": "51991-312-80", "marketing_start_date": "20170301"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-312-90)", "package_ndc": "51991-312-90", "marketing_start_date": "20170301"}], "brand_name": "Desvenlafaxine", "product_id": "51991-312_34b890a1-3d88-43fb-b54b-f168ae22ebc7", "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": "51991-312", "generic_name": "Desvenlafaxine Succinate", "labeler_name": "Breckenridge Pharmaceutical, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Desvenlafaxine", "active_ingredients": [{"name": "DESVENLAFAXINE SUCCINATE", "strength": "100 mg/1"}], "application_number": "ANDA204003", "marketing_category": "ANDA", "marketing_start_date": "20170301", "listing_expiration_date": "20261231"}