desvenlafaxine

Generic: desvenlafaxine

Labeler: marlex pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name desvenlafaxine
Generic Name desvenlafaxine
Labeler marlex pharmaceuticals, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

desvenlafaxine succinate 50 mg/1

Manufacturer
Marlex Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 10135-821
Product ID 10135-821_387ce260-7ac6-36e8-e063-6394a90a4e49
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204805
Listing Expiration 2026-12-31
Marketing Start 2025-07-01

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 10135821
Hyphenated Format 10135-821

Supplemental Identifiers

RxCUI
1874553 1874559
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 ANDA204805 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-821-10)
  • 14 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-821-14)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-821-30)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-821-90)
source: ndc

Packages (4)

10135-821-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-821-10) 10135-821-14 14 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-821-14) 10135-821-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-821-30) 10135-821-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-821-90)

Ingredients (1)

desvenlafaxine succinate (50 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": "387ce260-7ac6-36e8-e063-6394a90a4e49", "openfda": {"unii": ["ZB22ENF0XR"], "rxcui": ["1874553", "1874559"], "spl_set_id": ["387cea91-6924-2a68-e063-6394a90a8f75"], "manufacturer_name": ["Marlex Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-821-10)", "package_ndc": "10135-821-10", "marketing_start_date": "20250701"}, {"sample": false, "description": "14 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-821-14)", "package_ndc": "10135-821-14", "marketing_start_date": "20250701"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-821-30)", "package_ndc": "10135-821-30", "marketing_start_date": "20250701"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-821-90)", "package_ndc": "10135-821-90", "marketing_start_date": "20250701"}], "brand_name": "Desvenlafaxine", "product_id": "10135-821_387ce260-7ac6-36e8-e063-6394a90a4e49", "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": "10135-821", "generic_name": "Desvenlafaxine", "labeler_name": "Marlex Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Desvenlafaxine", "active_ingredients": [{"name": "DESVENLAFAXINE SUCCINATE", "strength": "50 mg/1"}], "application_number": "ANDA204805", "marketing_category": "ANDA", "marketing_start_date": "20250701", "listing_expiration_date": "20261231"}