FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
50771-005
11-digit product format
507710005
Labeler code
50771
Product ID
50771-005_4502de86-571d-cfb3-e063-6294a90a34f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Yaopharma Co., Ltd.
Application
ANDA202036
Marketing category
ANDA
Marketing start
2016-09-06
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
100 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 HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui313580, 313582, 313584, 313586, 314277

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50771-005-022024-01-30C16284748780-11030e365-4501-111a-e063-dadaa90a10e2VENLAFAXINE TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50771-005-02Venlafaxine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET10019

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50771-005VENLAFAXINE HYDROCHLORIDE TABLET [YAOPHARMA CO., LTD.]17Current NDC, Legacy NDC, 1 package rows20241220_38fd2c97-cd30-2f7d-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313580venlafaxine HCl 100 MG Oral TabletPSN38fd2c97-cd30-2f7d-e054-00144ff8d46c19
313582venlafaxine HCl 25 MG Oral TabletPSN38fd2c97-cd30-2f7d-e054-00144ff8d46c19
313584venlafaxine HCl 37.5 MG Oral TabletPSN38fd2c97-cd30-2f7d-e054-00144ff8d46c19
314277venlafaxine HCl 50 MG Oral TabletPSN38fd2c97-cd30-2f7d-e054-00144ff8d46c19
313586venlafaxine HCl 75 MG Oral TabletPSN38fd2c97-cd30-2f7d-e054-00144ff8d46c19
313580venlafaxine 100 MG Oral TabletSCD38fd2c97-cd30-2f7d-e054-00144ff8d46c19
313582venlafaxine 25 MG Oral TabletSCD38fd2c97-cd30-2f7d-e054-00144ff8d46c19
313584venlafaxine 37.5 MG Oral TabletSCD38fd2c97-cd30-2f7d-e054-00144ff8d46c19
314277venlafaxine 50 MG Oral TabletSCD38fd2c97-cd30-2f7d-e054-00144ff8d46c19
313586venlafaxine 75 MG Oral TabletSCD38fd2c97-cd30-2f7d-e054-00144ff8d46c19
313580venlafaxine 100 MG (as venlafaxine hydrochloride 113 MG) Oral TabletSY38fd2c97-cd30-2f7d-e054-00144ff8d46c19
313582venlafaxine 25 MG (as venlafaxine hydrochloride 28.3 MG) Oral TabletSY38fd2c97-cd30-2f7d-e054-00144ff8d46c19
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSY38fd2c97-cd30-2f7d-e054-00144ff8d46c19
314277venlafaxine 50 MG (as venlafaxine hydrochloride 56.6 MG) Oral TabletSY38fd2c97-cd30-2f7d-e054-00144ff8d46c19
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSY38fd2c97-cd30-2f7d-e054-00144ff8d46c19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50771-005-0250771000502100 TABLET in 1 BOTTLE, PLASTIC (50771-005-02) 100 tablet2016-09-060000-00-00NoNoCurrent