FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
76420-630
11-digit product format
764200630
Labeler code
76420
Product ID
76420-630_51d1cf0b-ea69-e7ff-e063-6294a90ad233
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA200834
Marketing category
ANDA
Marketing start
2011-06-01
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
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 HYDROCHLORIDE37.5 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
76420-630-01Venlafaxine Hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1003
76420-630-15Venlafaxine Hydrochloride15 in 1 BOTTLECAPSULE, EXTENDED RELEASE153
76420-630-30Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE303
76420-630-60Venlafaxine Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE603
76420-630-90Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-630VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ASCLEMED USA, INC.]2Current NDC, 5 package rows20250227_c69d16fd-b82d-4708-aece-ab4f60b29cc6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNc69d16fd-b82d-4708-aece-ab4f60b29cc63
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSNc69d16fd-b82d-4708-aece-ab4f60b29cc63
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNc69d16fd-b82d-4708-aece-ab4f60b29cc63
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDc69d16fd-b82d-4708-aece-ab4f60b29cc63
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCDc69d16fd-b82d-4708-aece-ab4f60b29cc63
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDc69d16fd-b82d-4708-aece-ab4f60b29cc63
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYc69d16fd-b82d-4708-aece-ab4f60b29cc63
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSYc69d16fd-b82d-4708-aece-ab4f60b29cc63
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYc69d16fd-b82d-4708-aece-ab4f60b29cc63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76420-630-0176420063001100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-630-01) 2023-10-18NoNoHistorical
76420-630-157642006301515 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-630-15) 2023-10-18NoNoHistorical
76420-630-307642006303030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-630-30) 2023-10-18NoNoHistorical
76420-630-607642006306060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-630-60) 2023-10-18NoNoHistorical
76420-630-907642006309090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-630-90) 2023-10-18NoNoHistorical