desvenlafaxine

Generic: desvenlafaxine succinate

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name desvenlafaxine
Generic Name desvenlafaxine succinate
Labeler alembic pharmaceuticals limited
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

desvenlafaxine succinate 25 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-542
Product ID 46708-542_162ec8ed-f695-4db2-badf-4afb6b9e1cba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204003
Listing Expiration 2026-12-31
Marketing Start 2018-09-14

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 46708542
Hyphenated Format 46708-542

Supplemental Identifiers

RxCUI
1607617 1874553 1874559
UPC
0346708540302 0346708541309 0346708542306
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
  • 25 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 CARTON (46708-542-10)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-542-30)
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-542-31)
  • 80 TABLET, EXTENDED RELEASE in 1 CARTON (46708-542-80)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-542-90)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-542-91)
source: ndc

Packages (6)

46708-542-10 100 TABLET, EXTENDED RELEASE in 1 CARTON (46708-542-10) 46708-542-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-542-30) 46708-542-31 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-542-31) 46708-542-80 80 TABLET, EXTENDED RELEASE in 1 CARTON (46708-542-80) 46708-542-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-542-90) 46708-542-91 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-542-91)

Ingredients (1)

desvenlafaxine succinate (25 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": "162ec8ed-f695-4db2-badf-4afb6b9e1cba", "openfda": {"upc": ["0346708540302", "0346708541309", "0346708542306"], "unii": ["ZB22ENF0XR"], "rxcui": ["1607617", "1874553", "1874559"], "spl_set_id": ["5bd203d2-477e-4d12-a875-cb8009f42410"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 CARTON (46708-542-10)", "package_ndc": "46708-542-10", "marketing_start_date": "20180914"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-542-30)", "package_ndc": "46708-542-30", "marketing_start_date": "20180914"}, {"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-542-31)", "package_ndc": "46708-542-31", "marketing_start_date": "20180914"}, {"sample": false, "description": "80 TABLET, EXTENDED RELEASE in 1 CARTON (46708-542-80)", "package_ndc": "46708-542-80", "marketing_start_date": "20180914"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-542-90)", "package_ndc": "46708-542-90", "marketing_start_date": "20180914"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-542-91)", "package_ndc": "46708-542-91", "marketing_start_date": "20180914"}], "brand_name": "Desvenlafaxine", "product_id": "46708-542_162ec8ed-f695-4db2-badf-4afb6b9e1cba", "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": "46708-542", "generic_name": "Desvenlafaxine Succinate", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Desvenlafaxine", "active_ingredients": [{"name": "DESVENLAFAXINE SUCCINATE", "strength": "25 mg/1"}], "application_number": "ANDA204003", "marketing_category": "ANDA", "marketing_start_date": "20180914", "listing_expiration_date": "20261231"}