FDA.reportPublic FDA data

Venlafaxine HCL ER

Product NDC
72189-363
11-digit product format
721890363
Labeler code
72189
Product ID
72189-363_2c4c85cc-c2bb-ac98-e063-6294a90a973c
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
2022-06-22
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 HCL ER
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
72189-363-30Venlafaxine HCL ER30 in 1 BOTTLECAPSULE, EXTENDED RELEASE304
72189-363-60Venlafaxine HCL ER60 in 1 BOTTLECAPSULE, EXTENDED RELEASE604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-363-30EA - Each72189-36380078f73-5cc0-4495-9102-d986ba194a2e12022-09-12
72189-363-60EA - Each72189-363a2fee00c-8fb2-49de-822b-8060a70c9d4312022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-363VENLAFAXINE HCL ER CAPSULE, EXTENDED RELEASE [DIRECT_RX]4Current NDC, Legacy NDC, 2 package rows20250123_e20b7d9e-f755-4325-e053-2995a90ac45d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSNe20b7d9e-f755-4325-e053-2995a90ac45d4
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCDe20b7d9e-f755-4325-e053-2995a90ac45d4
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSYe20b7d9e-f755-4325-e053-2995a90ac45d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-363-307218903633030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72189-363-30) 2022-08-260000-00-00NoNoCurrent
72189-363-607218903636060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72189-363-60) 2022-06-220000-00-00NoNoCurrent