FDA.reportPublic FDA data

Venlafaxine

Product NDC
71209-088
11-digit product format
712090088
Labeler code
71209
Product ID
71209-088_5e8d05f3-2a6f-4132-b7e3-9dc90804f2d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Cadila Pharmaceuticals Limited
Application
ANDA211323
Marketing category
ANDA
Marketing start
2018-01-05
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
150 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 HYDROCHLORIDE150 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
b1435b59-059c-404b-a587-53656bf80e17Product name120230314
6005cd75-f7b1-d6be-3cb5-4bd30d5c4617Product name320190314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71209-088-01Venlafaxine30 in 1 BOTTLETABLET, COATED309
71209-088-04Venlafaxine90 in 1 BOTTLETABLET, COATED909
71209-088-11Venlafaxine1000 in 1 BOTTLETABLET, COATED10009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71209-088VENLAFAXINE TABLET, COATED [CADILA PHARMACEUTICALS LIMITED]9Current NDC, Legacy NDC, 3 package rows20240301_516e7566-35c2-4a25-88d8-54d9dbc8f6be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808744venlafaxine HCl 150 MG 24HR Extended Release Oral TabletPSN516e7566-35c2-4a25-88d8-54d9dbc8f6be9
808748venlafaxine HCl 225 MG 24HR Extended Release Oral TabletPSN516e7566-35c2-4a25-88d8-54d9dbc8f6be9
808753venlafaxine HCl 75 MG 24HR Extended Release Oral TabletPSN516e7566-35c2-4a25-88d8-54d9dbc8f6be9
80874424 HR venlafaxine 150 MG Extended Release Oral TabletSCD516e7566-35c2-4a25-88d8-54d9dbc8f6be9
80874824 HR venlafaxine 225 MG Extended Release Oral TabletSCD516e7566-35c2-4a25-88d8-54d9dbc8f6be9
80875324 HR venlafaxine 75 MG Extended Release Oral TabletSCD516e7566-35c2-4a25-88d8-54d9dbc8f6be9
808744venlafaxine 150 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY516e7566-35c2-4a25-88d8-54d9dbc8f6be9
808744venlafaxine 150 MG 24 HR Extended Release Oral TabletSY516e7566-35c2-4a25-88d8-54d9dbc8f6be9
808748venlafaxine 225 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY516e7566-35c2-4a25-88d8-54d9dbc8f6be9
808748venlafaxine 225 MG 24 HR Extended Release Oral TabletSY516e7566-35c2-4a25-88d8-54d9dbc8f6be9
808753venlafaxine 75 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY516e7566-35c2-4a25-88d8-54d9dbc8f6be9
808753venlafaxine 75 MG 24 HR Extended Release Oral TabletSY516e7566-35c2-4a25-88d8-54d9dbc8f6be9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71209-088-017120900880130 TABLET, COATED in 1 BOTTLE (71209-088-01) 2018-08-160000-00-00NoNoCurrent
71209-088-047120900880490 TABLET, COATED in 1 BOTTLE (71209-088-04) 2018-08-160000-00-00NoNoCurrent
71209-088-11712090088111000 TABLET, COATED in 1 BOTTLE (71209-088-11) 2018-08-160000-00-00NoNoCurrent