FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
68788-8068
11-digit product format
687888068
Labeler code
68788
Product ID
68788-8068_c59a3cd5-55ac-4cb2-9e63-325f42e0602e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA212277
Marketing category
ANDA
Marketing start
2021-08-23
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
68788-8068-3Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE305
68788-8068-6Venlafaxine Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE605
68788-8068-9Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8068-3EA - Each68788-8068fabb3f07-9d95-40b2-9086-af1c82c34b4d12021-10-08
68788-8068-6EA - Each68788-80684c1f493a-61df-4f9e-95c1-f0ce2b3832a212021-10-08
68788-8068-9EA - Each68788-806819137081-1e1c-42bc-8a43-6895d630db6712021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8068VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 3 package rows20240830_653f3f95-98d0-4ce0-bf10-ac7938be690e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN653f3f95-98d0-4ce0-bf10-ac7938be690e5
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD653f3f95-98d0-4ce0-bf10-ac7938be690e5
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY653f3f95-98d0-4ce0-bf10-ac7938be690e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8068-36878880680330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-8068-3) 2021-08-230000-00-00NoNoCurrent
68788-8068-66878880680660 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-8068-6) 2021-08-230000-00-00NoNoCurrent
68788-8068-96878880680990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-8068-9) 2021-08-230000-00-00NoNoCurrent