Venlafaxine

Product NDC
70771-1650
11-digit product format
707711650
Labeler code
70771
Product ID
70771-1650_0bf02fa2-e5cd-42d6-ab41-1ecd150b7c57
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA215622
Marketing category
ANDA
Marketing start
2022-09-01
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui808744, 808748, 808751, 808753

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1650-1Venlafaxine100 in 1 BOTTLETABLET, EXTENDED RELEASE1002
70771-1650-3Venlafaxine30 in 1 BOTTLETABLET, EXTENDED RELEASE302
70771-1650-9Venlafaxine90 in 1 BOTTLETABLET, EXTENDED RELEASE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1650VENLAFAXINE TABLET, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]2Current NDC, Legacy NDC, 3 package rows20231005_750333ce-a512-42e1-b9e3-179714b488df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808744venlafaxine HCl 150 MG 24HR Extended Release Oral TabletPSN750333ce-a512-42e1-b9e3-179714b488df2
808748venlafaxine HCl 225 MG 24HR Extended Release Oral TabletPSN750333ce-a512-42e1-b9e3-179714b488df2
808751venlafaxine HCl 37.5 MG 24HR Extended Release Oral TabletPSN750333ce-a512-42e1-b9e3-179714b488df2
808753venlafaxine HCl 75 MG 24HR Extended Release Oral TabletPSN750333ce-a512-42e1-b9e3-179714b488df2
80874424 HR venlafaxine 150 MG Extended Release Oral TabletSCD750333ce-a512-42e1-b9e3-179714b488df2
80874824 HR venlafaxine 225 MG Extended Release Oral TabletSCD750333ce-a512-42e1-b9e3-179714b488df2
80875124 HR venlafaxine 37.5 MG Extended Release Oral TabletSCD750333ce-a512-42e1-b9e3-179714b488df2
80875324 HR venlafaxine 75 MG Extended Release Oral TabletSCD750333ce-a512-42e1-b9e3-179714b488df2
808744venlafaxine 150 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY750333ce-a512-42e1-b9e3-179714b488df2
808744venlafaxine 150 MG 24 HR Extended Release Oral TabletSY750333ce-a512-42e1-b9e3-179714b488df2
808748venlafaxine 225 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY750333ce-a512-42e1-b9e3-179714b488df2
808748venlafaxine 225 MG 24 HR Extended Release Oral TabletSY750333ce-a512-42e1-b9e3-179714b488df2
808751venlafaxine 37.5 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY750333ce-a512-42e1-b9e3-179714b488df2
808751venlafaxine 37.5 MG 24 HR Extended Release Oral TabletSY750333ce-a512-42e1-b9e3-179714b488df2
808753venlafaxine 75 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY750333ce-a512-42e1-b9e3-179714b488df2
808753venlafaxine 75 MG 24 HR Extended Release Oral TabletSY750333ce-a512-42e1-b9e3-179714b488df2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70771-1650-170771165001100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1650-1) 2022-09-010000-00-00NoNoCurrent
70771-1650-37077116500330 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1650-3) 2022-09-010000-00-00NoNoCurrent
70771-1650-97077116500990 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1650-9) 2022-09-010000-00-00NoNoCurrent