FDA.reportPublic FDA data

venlafaxine

Product NDC
71335-1213
11-digit product format
713351213
Labeler code
71335
Product ID
71335-1213_5d4798d1-87f3-44fc-a6fc-ae748478faa6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090555
Marketing category
ANDA
Marketing start
2010-04-07
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE37.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui313584

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
71335-1213-1venlafaxine30 in 1 BOTTLETABLET30101
71335-1213-2venlafaxine60 in 1 BOTTLETABLET60101
71335-1213-3venlafaxine90 in 1 BOTTLETABLET90101
71335-1213-4venlafaxine10 in 1 BOTTLETABLET10101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1213-2EA - Each71335-12135a686faa-7acb-4d7d-aa8e-30e981c2d64f12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1213VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 4 package rows20231026_49e5833b-4693-45b5-9abb-1b369eb4086d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313584venlafaxine HCl 37.5 MG Oral TabletPSN49e5833b-4693-45b5-9abb-1b369eb4086d101
313584venlafaxine 37.5 MG Oral TabletSCD49e5833b-4693-45b5-9abb-1b369eb4086d101
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSY49e5833b-4693-45b5-9abb-1b369eb4086d101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1213-17133512130130 TABLET in 1 BOTTLE (71335-1213-1) 30 tablet2022-02-090000-00-00NoNoCurrent
71335-1213-27133512130260 TABLET in 1 BOTTLE (71335-1213-2) 60 tablet2022-02-090000-00-00NoNoCurrent
71335-1213-37133512130390 TABLET in 1 BOTTLE (71335-1213-3) 90 tablet2022-02-090000-00-00NoNoCurrent
71335-1213-47133512130410 TABLET in 1 BOTTLE (71335-1213-4) 10 tablet2022-02-090000-00-00NoNoCurrent