MedPath
FDA Approval

Venlafaxine

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Northstar Rx LLC
DUNS: 830546433
Effective Date
October 30, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Venlafaxine(100 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

ALKALOIDA chemical company Zrt

Northstar Rx LLC

643611692

Products5

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Venlafaxine

Product Details

NDC Product Code
16714-659
Application Number
ANDA078627
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
October 30, 2023
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
Code: 7D7RX5A8MOClass: ACTIMQuantity: 100 mg in 1 1

Venlafaxine

Product Details

NDC Product Code
16714-658
Application Number
ANDA078627
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
October 30, 2023
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
Code: 7D7RX5A8MOClass: ACTIMQuantity: 75 mg in 1 1
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT

Venlafaxine

Product Details

NDC Product Code
16714-656
Application Number
ANDA078627
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
October 30, 2023
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
Code: 7D7RX5A8MOClass: ACTIMQuantity: 37.5 mg in 1 1

Venlafaxine

Product Details

NDC Product Code
16714-655
Application Number
ANDA078627
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
October 30, 2023
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
Code: 7D7RX5A8MOClass: ACTIMQuantity: 25 mg in 1 1

Venlafaxine

Product Details

NDC Product Code
16714-657
Application Number
ANDA078627
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
October 30, 2023
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
Code: 7D7RX5A8MOClass: ACTIMQuantity: 50 mg in 1 1
© Copyright 2025. All Rights Reserved by MedPath