FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
68788-8752
11-digit product format
687888752
Labeler code
68788
Product ID
68788-8752_b16b2e74-763b-4b6b-8291-258d94bb9d9f
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
2024-10-14
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
68788-8752-3Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE302
68788-8752-6Venlafaxine Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE602
68788-8752-9Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8752-3EA - Each68788-875213e78835-06aa-494e-a7de-d4d800c2818b12024-12-10
68788-8752-6EA - Each68788-8752a1a41660-ce77-4c3e-98b3-bcda31eb2df212024-12-10
68788-8752-9EA - Each68788-875270094eee-60b4-4e55-ba8c-4597161412ed12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8752VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 3 package rows20241016_e2d5a2d5-5e55-426c-bc8d-d29729eba775.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNe2d5a2d5-5e55-426c-bc8d-d29729eba7752
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDe2d5a2d5-5e55-426c-bc8d-d29729eba7752
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYe2d5a2d5-5e55-426c-bc8d-d29729eba7752

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8752-36878887520330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-8752-3) 2024-10-14NoNoHistorical
68788-8752-66878887520660 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-8752-6) 2024-10-14NoNoHistorical
68788-8752-96878887520990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-8752-9) 2024-10-14NoNoHistorical