FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
47335-760
11-digit product format
473350760
Labeler code
47335
Product ID
47335-760_dae15132-d26b-4ea9-b937-da9c282ada48
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA091272
Marketing category
ANDA
Marketing start
2014-12-15
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
37.5 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 HYDROCHLORIDE37.5 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b1435b59-059c-404b-a587-53656bf80e17Product name120230314
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
6005cd75-f7b1-d6be-3cb5-4bd30d5c4617Product name320190314
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47335-760-08Venlafaxine Hydrochloride100 in 1 BOTTLETABLET, EXTENDED RELEASE10012
47335-760-18Venlafaxine Hydrochloride1000 in 1 BOTTLETABLET, EXTENDED RELEASE100012
47335-760-61Venlafaxine Hydrochloride10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1012
47335-760-61Venlafaxine Hydrochloride10 in 1 BOX, UNIT-DOSETABLET, EXTENDED RELEASE1012
47335-760-81Venlafaxine Hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE9012
47335-760-83Venlafaxine Hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE3012
47335-760-88Venlafaxine Hydrochloride100 in 1 BOTTLETABLET, EXTENDED RELEASE10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-760-81EA - Each47335-760933151c6-9261-42f8-978b-0460d7f85dde12018-05-09
47335-760-83EA - Each47335-760d95b0ddc-5697-42fa-9ed7-b44a4876efa912018-05-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]1
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKVENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]1
DIBUTYL SEBACATEINACTIVE INGREDIENT4W5IH7FLNYVENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAVENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]1
HYPROMELLOSE 2208 (4000 MPA.S)INACTIVE INGREDIENT39J80LT57TVENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XVENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AVENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JVENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PVENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHVENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HVENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XVENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JVENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]1
TALCINACTIVE INGREDIENT7SEV7J4R1UVENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMVENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-760VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]12Current NDC, Legacy NDC, 7 package rows20230916_dc989aa7-c4ab-4359-a971-523eb477ef9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808744venlafaxine HCl 150 MG 24HR Extended Release Oral TabletPSNdc989aa7-c4ab-4359-a971-523eb477ef9b12
808748venlafaxine HCl 225 MG 24HR Extended Release Oral TabletPSNdc989aa7-c4ab-4359-a971-523eb477ef9b12
808751venlafaxine HCl 37.5 MG 24HR Extended Release Oral TabletPSNdc989aa7-c4ab-4359-a971-523eb477ef9b12
808753venlafaxine HCl 75 MG 24HR Extended Release Oral TabletPSNdc989aa7-c4ab-4359-a971-523eb477ef9b12
80874424 HR venlafaxine 150 MG Extended Release Oral TabletSCDdc989aa7-c4ab-4359-a971-523eb477ef9b12
80874824 HR venlafaxine 225 MG Extended Release Oral TabletSCDdc989aa7-c4ab-4359-a971-523eb477ef9b12
80875124 HR venlafaxine 37.5 MG Extended Release Oral TabletSCDdc989aa7-c4ab-4359-a971-523eb477ef9b12
80875324 HR venlafaxine 75 MG Extended Release Oral TabletSCDdc989aa7-c4ab-4359-a971-523eb477ef9b12
808744venlafaxine 150 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSYdc989aa7-c4ab-4359-a971-523eb477ef9b12
808744venlafaxine 150 MG 24 HR Extended Release Oral TabletSYdc989aa7-c4ab-4359-a971-523eb477ef9b12
808748venlafaxine 225 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSYdc989aa7-c4ab-4359-a971-523eb477ef9b12
808748venlafaxine 225 MG 24 HR Extended Release Oral TabletSYdc989aa7-c4ab-4359-a971-523eb477ef9b12
808751venlafaxine 37.5 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSYdc989aa7-c4ab-4359-a971-523eb477ef9b12
808751venlafaxine 37.5 MG 24 HR Extended Release Oral TabletSYdc989aa7-c4ab-4359-a971-523eb477ef9b12
808753venlafaxine 75 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSYdc989aa7-c4ab-4359-a971-523eb477ef9b12
808753venlafaxine 75 MG 24 HR Extended Release Oral TabletSYdc989aa7-c4ab-4359-a971-523eb477ef9b12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47335-760-0847335076008100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-760-08) 2014-12-150000-00-00NoNoCurrent
47335-760-18473350760181000 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-760-18) 2014-12-150000-00-00NoNoCurrent
47335-760-614733507606110 BLISTER PACK in 1 BOX, UNIT-DOSE (47335-760-61) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2019-03-290000-00-00NoNoCurrent
47335-760-814733507608190 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-760-81) 2014-12-150000-00-00NoNoCurrent
47335-760-834733507608330 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-760-83) 2014-12-150000-00-00NoNoCurrent
47335-760-8847335076088100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-760-88) 2014-12-150000-00-00NoNoCurrent