FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
68788-7919
11-digit product format
687887919
Labeler code
68788
Product ID
68788-7919_5de1975f-6072-482f-be36-7bde9576d086
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
2021-06-14
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b1435b59-059c-404b-a587-53656bf80e17Product name120230314
6005cd75-f7b1-d6be-3cb5-4bd30d5c4617Product name320190314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7919-3Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE305
68788-7919-6Venlafaxine Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE605
68788-7919-9Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7919-3EA - Each68788-7919df503912-c9ed-4141-adee-a9bcccc6fc6e12021-07-15
68788-7919-6EA - Each68788-7919e7d3c9c2-0356-4221-96b6-f0ba607b781112021-07-15
68788-7919-9EA - Each68788-7919022879a7-c0b9-47c6-924f-7702155bbe3612021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7919VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 3 package rows20240830_0c404290-2806-4756-bca3-2d639b400963.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN0c404290-2806-4756-bca3-2d639b4009635
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD0c404290-2806-4756-bca3-2d639b4009635
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY0c404290-2806-4756-bca3-2d639b4009635

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7919-36878879190330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-7919-3) 2021-06-140000-00-00NoNoCurrent
68788-7919-66878879190660 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-7919-6) 2021-06-140000-00-00NoNoCurrent
68788-7919-96878879190990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-7919-9) 2021-06-140000-00-00NoNoCurrent