venlafaxine hydrochloride

Generic: venlafaxine hydrochloride

Labeler: epic pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name venlafaxine hydrochloride
Generic Name venlafaxine hydrochloride
Labeler epic pharma, llc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

venlafaxine hydrochloride 37.5 mg/1

Manufacturer
Epic Pharma, LLC

Identifiers & Regulatory

Product NDC 42806-601
Product ID 42806-601_4bde62db-14e4-fede-e063-6294a90a1391
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214654
Listing Expiration 2027-12-31
Marketing Start 2022-09-07

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 42806601
Hyphenated Format 42806-601

Supplemental Identifiers

RxCUI
313581 313583 313585
UPC
0342806603093 0342806601099 0342806601303 0342806602102 0342806603307 0342806603055 0342806602096 0342806602300 0342806601105
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 ANDA214654 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 37.5 mg/1
source: ndc
Packaging
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42806-601-09)
  • 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42806-601-10)
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42806-601-30)
source: ndc

Packages (3)

42806-601-09 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42806-601-09) 42806-601-10 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42806-601-10) 42806-601-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42806-601-30)

Ingredients (1)

venlafaxine hydrochloride (37.5 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": "4bde62db-14e4-fede-e063-6294a90a1391", "openfda": {"upc": ["0342806603093", "0342806601099", "0342806601303", "0342806602102", "0342806603307", "0342806603055", "0342806602096", "0342806602300", "0342806601105"], "unii": ["7D7RX5A8MO"], "rxcui": ["313581", "313583", "313585"], "spl_set_id": ["430777f0-347c-4f21-8c5d-55f4e9897e74"], "manufacturer_name": ["Epic Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42806-601-09)", "package_ndc": "42806-601-09", "marketing_start_date": "20220907"}, {"sample": false, "description": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42806-601-10)", "package_ndc": "42806-601-10", "marketing_start_date": "20220907"}, {"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42806-601-30)", "package_ndc": "42806-601-30", "marketing_start_date": "20220907"}], "brand_name": "Venlafaxine Hydrochloride", "product_id": "42806-601_4bde62db-14e4-fede-e063-6294a90a1391", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "42806-601", "generic_name": "Venlafaxine Hydrochloride", "labeler_name": "Epic Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Venlafaxine Hydrochloride", "active_ingredients": [{"name": "VENLAFAXINE HYDROCHLORIDE", "strength": "37.5 mg/1"}], "application_number": "ANDA214654", "marketing_category": "ANDA", "marketing_start_date": "20220907", "listing_expiration_date": "20271231"}