FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
71335-1864
11-digit product format
713351864
Labeler code
71335
Product ID
71335-1864_af6d8477-603b-493d-866c-d72c01840f90
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA200834
Marketing category
ANDA
Marketing start
2011-06-01
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
Rxcui313583

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
71335-1864-1Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE30104
71335-1864-2Venlafaxine Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE60104
71335-1864-3Venlafaxine Hydrochloride10 in 1 BOTTLECAPSULE, EXTENDED RELEASE10104
71335-1864-4Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE90104
71335-1864-5Venlafaxine Hydrochloride14 in 1 BOTTLECAPSULE, EXTENDED RELEASE14104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1864VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 5 package rows20240602_bff505db-2752-41fc-a4dd-4773f629106e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSNbff505db-2752-41fc-a4dd-4773f629106e104
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCDbff505db-2752-41fc-a4dd-4773f629106e104
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSYbff505db-2752-41fc-a4dd-4773f629106e104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1864-17133518640130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1864-1) 2021-09-030000-00-00NoNoCurrent
71335-1864-27133518640260 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1864-2) 2021-05-270000-00-00NoNoCurrent
71335-1864-37133518640310 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1864-3) 2024-05-300000-00-00NoNoCurrent
71335-1864-47133518640490 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1864-4) 2021-06-030000-00-00NoNoCurrent
71335-1864-57133518640514 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1864-5) 2024-05-300000-00-00NoNoCurrent