FDA.reportPublic FDA data

VENLAFAXINE HYDROCHLORIDE

Product NDC
75834-217
11-digit product format
758340217
Labeler code
75834
Product ID
75834-217_bb5cc2c4-6d14-42aa-a9af-dc29bae4f238
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VENLAFAXINE HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Nivagen Pharmaceuticals, Inc.
Application
ANDA211323
Marketing category
ANDA
Marketing start
2019-09-06
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
75 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VENLAFAXINE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui808744, 808748, 808753

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
17db3736-056c-48b9-b0f4-00fccabb14e6Product name520251118
7be8b949-f2c0-bdd8-e89d-8af92c1b2eadProduct name920250224
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
b1435b59-059c-404b-a587-53656bf80e17Product name120230314
6005cd75-f7b1-d6be-3cb5-4bd30d5c4617Product name320190314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75834-217-00VENLAFAXINE HYDROCHLORIDE1000 in 1 BOTTLETABLET, EXTENDED RELEASE10002
75834-217-30VENLAFAXINE HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE302
75834-217-90VENLAFAXINE HYDROCHLORIDE90 in 1 BOTTLETABLET, EXTENDED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-217-30EA - Each75834-217c9712d1a-fb8f-43ae-876c-f9d1d24dca7c12020-01-03
75834-217-90EA - Each75834-217617303bd-1414-446e-949c-5026a13d37c612020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-217VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [NIVAGEN PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 3 package rows20210115_45cb4c19-fbf4-4ff5-af6f-b25a31ebc1e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808744venlafaxine HCl 150 MG 24HR Extended Release Oral TabletPSN45cb4c19-fbf4-4ff5-af6f-b25a31ebc1e12
808748venlafaxine HCl 225 MG 24HR Extended Release Oral TabletPSN45cb4c19-fbf4-4ff5-af6f-b25a31ebc1e12
808753venlafaxine HCl 75 MG 24HR Extended Release Oral TabletPSN45cb4c19-fbf4-4ff5-af6f-b25a31ebc1e12
80874424 HR venlafaxine 150 MG Extended Release Oral TabletSCD45cb4c19-fbf4-4ff5-af6f-b25a31ebc1e12
80874824 HR venlafaxine 225 MG Extended Release Oral TabletSCD45cb4c19-fbf4-4ff5-af6f-b25a31ebc1e12
80875324 HR venlafaxine 75 MG Extended Release Oral TabletSCD45cb4c19-fbf4-4ff5-af6f-b25a31ebc1e12
808744venlafaxine 150 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY45cb4c19-fbf4-4ff5-af6f-b25a31ebc1e12
808744venlafaxine 150 MG 24 HR Extended Release Oral TabletSY45cb4c19-fbf4-4ff5-af6f-b25a31ebc1e12
808748venlafaxine 225 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY45cb4c19-fbf4-4ff5-af6f-b25a31ebc1e12
808748venlafaxine 225 MG 24 HR Extended Release Oral TabletSY45cb4c19-fbf4-4ff5-af6f-b25a31ebc1e12
808753venlafaxine 75 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY45cb4c19-fbf4-4ff5-af6f-b25a31ebc1e12
808753venlafaxine 75 MG 24 HR Extended Release Oral TabletSY45cb4c19-fbf4-4ff5-af6f-b25a31ebc1e12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
75834-217-00758340217001000 TABLET, EXTENDED RELEASE in 1 BOTTLE (75834-217-00) 2019-09-060000-00-00NoNoCurrent
75834-217-307583402173030 TABLET, EXTENDED RELEASE in 1 BOTTLE (75834-217-30) 2019-09-060000-00-00NoNoCurrent
75834-217-907583402179090 TABLET, EXTENDED RELEASE in 1 BOTTLE (75834-217-90) 2019-09-060000-00-00NoNoCurrent