FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
0904-7488
11-digit product format
009047488
Labeler code
0904
Product ID
0904-7488_d962f5af-7642-4c6e-b7be-3e089fe48873
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA200834
Marketing category
ANDA
Marketing start
2025-10-08
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
Rxcui313581, 313583, 313585

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
0904-7488-61Venlafaxine Hydrochloride1 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE11
0904-7488-61Venlafaxine Hydrochloride100 in 1 CARTONCAPSULE, EXTENDED RELEASE1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7488-61EA - Each0904-7488a13328c0-8a95-44c7-95ea-8cabf48bcf1112025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNd962f5af-7642-4c6e-b7be-3e089fe488731
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSNd962f5af-7642-4c6e-b7be-3e089fe488731
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN7588ffdc-034d-4baf-9889-9a0ded265be51
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNd962f5af-7642-4c6e-b7be-3e089fe488731
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDd962f5af-7642-4c6e-b7be-3e089fe488731
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCDd962f5af-7642-4c6e-b7be-3e089fe488731
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD7588ffdc-034d-4baf-9889-9a0ded265be51
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDd962f5af-7642-4c6e-b7be-3e089fe488731
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYd962f5af-7642-4c6e-b7be-3e089fe488731
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSYd962f5af-7642-4c6e-b7be-3e089fe488731
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY7588ffdc-034d-4baf-9889-9a0ded265be51
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYd962f5af-7642-4c6e-b7be-3e089fe488731

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7488-6100904748861100 BLISTER PACK in 1 CARTON (0904-7488-61) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK100 blister pack2025-10-08NoNoCurrent