FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
68788-8140
11-digit product format
687888140
Labeler code
68788
Product ID
68788-8140_007d0508-5680-41b6-ba36-4c9cc4dd828f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA200834
Marketing category
ANDA
Marketing start
2022-02-11
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
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 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
68788-8140-3Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE304
68788-8140-6Venlafaxine Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE604
68788-8140-9Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8140-3EA - Each68788-8140b0cb02e0-786a-424b-8908-e2d7719a12c212022-03-09
68788-8140-6EA - Each68788-8140af140680-261c-4ffd-9340-483b5adc755712022-03-09
68788-8140-9EA - Each68788-8140a372c3ff-ef05-4865-9848-a887909ab6c312022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8140VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 3 package rows20240830_22980b32-cbae-4f37-9fc0-b47221b2c32e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN22980b32-cbae-4f37-9fc0-b47221b2c32e4
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD22980b32-cbae-4f37-9fc0-b47221b2c32e4
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY22980b32-cbae-4f37-9fc0-b47221b2c32e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8140-36878881400330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-8140-3) 2022-02-110000-00-00NoNoCurrent
68788-8140-66878881400660 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-8140-6) 2022-02-110000-00-00NoNoCurrent
68788-8140-96878881400990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-8140-9) 2022-02-110000-00-00NoNoCurrent