desvenlafaxine

Generic: desvenlafaxine

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name desvenlafaxine
Generic Name desvenlafaxine
Labeler hikma pharmaceuticals usa inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

desvenlafaxine succinate 100 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0401
Product ID 0054-0401_c5148154-683f-4369-bb65-9f6f43a64e2b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204083
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 00540401
Hyphenated Format 0054-0401

Supplemental Identifiers

RxCUI
1607617 1874553 1874559
UPC
0300540400132 0300540603137
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 (source: ndc)
Application Number ANDA204083 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0054-0401-13)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0054-0401-22)
source: ndc

Packages (2)

0054-0401-13 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0054-0401-13) 0054-0401-22 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0054-0401-22)

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": "c5148154-683f-4369-bb65-9f6f43a64e2b", "openfda": {"upc": ["0300540400132", "0300540603137"], "unii": ["ZB22ENF0XR"], "rxcui": ["1607617", "1874553", "1874559"], "spl_set_id": ["662890ff-d254-40e0-a9fe-f07ab94d65d6"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0054-0401-13)", "package_ndc": "0054-0401-13", "marketing_start_date": "20170301"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0054-0401-22)", "package_ndc": "0054-0401-22", "marketing_start_date": "20170301"}], "brand_name": "Desvenlafaxine", "product_id": "0054-0401_c5148154-683f-4369-bb65-9f6f43a64e2b", "dosage_form": "TABLET, FILM COATED, 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": "0054-0401", "generic_name": "Desvenlafaxine", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Desvenlafaxine", "active_ingredients": [{"name": "DESVENLAFAXINE SUCCINATE", "strength": "100 mg/1"}], "application_number": "ANDA204083", "marketing_category": "ANDA", "marketing_start_date": "20170301", "listing_expiration_date": "20261231"}