FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
68788-8682
11-digit product format
687888682
Labeler code
68788
Product ID
68788-8682_96b77279-4664-43cc-ae1e-dd893b00c6d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA214654
Marketing category
ANDA
Marketing start
2024-06-01
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
b1435b59-059c-404b-a587-53656bf80e17Product name120230314
6005cd75-f7b1-d6be-3cb5-4bd30d5c4617Product name320190314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8682-1Venlafaxine Hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1002
68788-8682-3Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE302
68788-8682-6Venlafaxine Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE602
68788-8682-8Venlafaxine Hydrochloride120 in 1 BOTTLECAPSULE, EXTENDED RELEASE1202
68788-8682-9Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8682-1EA - Each68788-8682b3ca8f06-76ba-4a2e-aeac-9f1a40aa788912024-08-12
68788-8682-3EA - Each68788-8682cbcb97a2-f06b-4bf5-b965-267350d4638412024-08-12
68788-8682-6EA - Each68788-8682118c83f5-996d-4cbe-8190-08183e5187e612024-08-12
68788-8682-8EA - Each68788-86827169ab7e-cbf4-414f-ae1b-d24cc385ee1412024-08-12
68788-8682-9EA - Each68788-8682620fbb9b-1b1a-480e-80b8-cc8f99af213f12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8682VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 5 package rows20240612_92b3f73d-d6ca-4d7d-9035-5700f527cb85.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN92b3f73d-d6ca-4d7d-9035-5700f527cb852
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD92b3f73d-d6ca-4d7d-9035-5700f527cb852
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY92b3f73d-d6ca-4d7d-9035-5700f527cb852

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8682-168788868201100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-8682-1) 2024-06-01NoNoHistorical
68788-8682-36878886820330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-8682-3) 2024-06-01NoNoHistorical
68788-8682-66878886820660 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-8682-6) 2024-06-01NoNoHistorical
68788-8682-868788868208120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-8682-8) 2024-06-01NoNoHistorical
68788-8682-96878886820990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-8682-9) 2024-06-01NoNoHistorical