venlafaxine hydrochloride

Generic: venlafaxine hydrochloride

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

Drug Facts

Product Profile

Brand Name venlafaxine hydrochloride
Generic Name venlafaxine hydrochloride
Labeler macleods pharmaceuticals limited
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

venlafaxine hydrochloride 75 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-195
Product ID 33342-195_ea9c3795-420f-49fb-918c-7033a1f06963
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204889
Listing Expiration 2026-12-31
Marketing Start 2017-10-06

Pharmacologic Class

Classes
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 33342195
Hyphenated Format 33342-195

Supplemental Identifiers

RxCUI
313581 313583 313585
UPC
0333342196071 0333342196569 0333342195074 0333342196156 0333342194152 0333342194077
UNII
7D7RX5A8MO

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 venlafaxine hydrochloride (source: ndc)
Generic Name venlafaxine hydrochloride (source: ndc)
Application Number ANDA204889 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-195-07)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-195-10)
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-195-11)
  • 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-195-15)
  • 10 BLISTER PACK in 1 CARTON (33342-195-56) / 14 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (5)

33342-195-07 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-195-07) 33342-195-10 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-195-10) 33342-195-11 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-195-11) 33342-195-15 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-195-15) 33342-195-56 10 BLISTER PACK in 1 CARTON (33342-195-56) / 14 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (1)

venlafaxine hydrochloride (75 mg/1)

Linked Drug Pages (1)

Venlafaxine hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ea9c3795-420f-49fb-918c-7033a1f06963", "openfda": {"upc": ["0333342196071", "0333342196569", "0333342195074", "0333342196156", "0333342194152", "0333342194077"], "unii": ["7D7RX5A8MO"], "rxcui": ["313581", "313583", "313585"], "spl_set_id": ["3e51f786-3691-4ec4-836b-7f2c9a385aa7"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-195-07)", "package_ndc": "33342-195-07", "marketing_start_date": "20171006"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-195-10)", "package_ndc": "33342-195-10", "marketing_start_date": "20180814"}, {"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-195-11)", "package_ndc": "33342-195-11", "marketing_start_date": "20180814"}, {"sample": false, "description": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-195-15)", "package_ndc": "33342-195-15", "marketing_start_date": "20171006"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (33342-195-56)  / 14 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "33342-195-56", "marketing_start_date": "20171006"}], "brand_name": "Venlafaxine hydrochloride", "product_id": "33342-195_ea9c3795-420f-49fb-918c-7033a1f06963", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "33342-195", "generic_name": "Venlafaxine hydrochloride", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Venlafaxine hydrochloride", "active_ingredients": [{"name": "VENLAFAXINE HYDROCHLORIDE", "strength": "75 mg/1"}], "application_number": "ANDA204889", "marketing_category": "ANDA", "marketing_start_date": "20171006", "listing_expiration_date": "20261231"}