FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
68788-8774
11-digit product format
687888774
Labeler code
68788
Product ID
68788-8774_3b13f051-c0d2-4c09-86f3-13c1c60fcf6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA090174
Marketing category
ANDA
Marketing start
2024-11-20
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
150 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 Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui313581

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
68788-8774-1Venlafaxine Hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1002
68788-8774-2Venlafaxine Hydrochloride20 in 1 BOTTLECAPSULE, EXTENDED RELEASE202
68788-8774-3Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE302
68788-8774-6Venlafaxine Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE602
68788-8774-8Venlafaxine Hydrochloride120 in 1 BOTTLECAPSULE, EXTENDED RELEASE1202
68788-8774-9Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8774-1EA - Each68788-87746b05271e-95bb-4ae0-a88a-0ab982c8731d12025-02-10
68788-8774-2EA - Each68788-8774e120bf8b-4799-4459-ac91-3d522c6255df12025-02-10
68788-8774-3EA - Each68788-877413846e7c-ab2d-4a3a-89ef-b7f90d3835f112025-02-10
68788-8774-6EA - Each68788-877477802462-1b8d-4b54-a21f-56d59ee3ec6b12025-02-10
68788-8774-8EA - Each68788-87746d6b8620-4a24-4b80-8b2b-b8d60843f38e12025-02-10
68788-8774-9EA - Each68788-8774c1115687-c581-4bf1-b728-e79f16dd8fcb12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8774VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 6 package rows20241127_c4312b7b-7a42-45f1-b6e6-e20ea76020c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNc4312b7b-7a42-45f1-b6e6-e20ea76020c42
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDc4312b7b-7a42-45f1-b6e6-e20ea76020c42
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYc4312b7b-7a42-45f1-b6e6-e20ea76020c42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8774-168788877401100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-8774-1) 2024-11-20NoNoHistorical
68788-8774-26878887740220 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-8774-2) 2024-11-20NoNoHistorical
68788-8774-36878887740330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-8774-3) 2024-11-20NoNoHistorical
68788-8774-66878887740660 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-8774-6) 2024-11-20NoNoHistorical
68788-8774-868788877408120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-8774-8) 2024-11-20NoNoHistorical
68788-8774-96878887740990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-8774-9) 2024-11-20NoNoHistorical