FDA.reportPublic FDA data

Venlafaxine HCL ER

Product NDC
72189-414
11-digit product format
721890414
Labeler code
72189
Product ID
72189-414_4c5d1a73-a4c5-11ab-e063-6294a90a276b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine HCL ER
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA200834
Marketing category
ANDA
Marketing start
2023-01-26
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Venlafaxine HCL ER
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui313585

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
72189-414-30Venlafaxine HCL ER30 in 1 BOTTLECAPSULE, EXTENDED RELEASE305
72189-414-60Venlafaxine HCL ER60 in 1 BOTTLECAPSULE, EXTENDED RELEASE605
72189-414-90Venlafaxine HCL ER90 in 1 BOTTLECAPSULE, EXTENDED RELEASE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-414-30EA - Each72189-414b41a82c6-aaaf-4b7e-b916-9ae8b73589ba12026-03-17
72189-414-60EA - Each72189-41432a10c29-f7e9-487a-b755-89216f472dca12023-03-13
72189-414-90EA - Each72189-4145ee96678-1f44-4973-8980-fc6fa95115c112026-03-17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-414VENLAFAXINE HCL ER CAPSULE, EXTENDED RELEASE [DIRECT_RX]3Current NDC, 3 package rows20250123_f32ca617-66e0-41d8-e053-2a95a90ae40a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNf32ca617-66e0-41d8-e053-2a95a90ae40a5
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDf32ca617-66e0-41d8-e053-2a95a90ae40a5
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYf32ca617-66e0-41d8-e053-2a95a90ae40a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72189-414-307218904143030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72189-414-30) 2023-01-26NoNoHistorical
72189-414-607218904146060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72189-414-60) 2023-01-26NoNoHistorical
72189-414-907218904149090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72189-414-90) 2023-01-26NoNoHistorical