FDA.reportPublic FDA data

VENLAFAXINE HYDROCHLORIDE

Product NDC
46708-793
11-digit product format
467080793
Labeler code
46708
Product ID
46708-793_e3e238db-4388-49bb-aa67-6d73adbb2280
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VENLAFAXINE HYDROCHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA217767
Marketing category
ANDA
Marketing start
2024-06-10
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
46708-793-30VENLAFAXINE HYDROCHLORIDE30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301
46708-793-31VENLAFAXINE HYDROCHLORIDE100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1001
46708-793-71VENLAFAXINE HYDROCHLORIDE500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5001
46708-793-90VENLAFAXINE HYDROCHLORIDE90 in 1 BOTTLECAPSULE, EXTENDED RELEASE901
46708-793-91VENLAFAXINE HYDROCHLORIDE1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-793VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]1Current NDC, 5 package rows20240612_e3e238db-4388-49bb-aa67-6d73adbb2280.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNe3e238db-4388-49bb-aa67-6d73adbb22801
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSNe3e238db-4388-49bb-aa67-6d73adbb22801
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNe3e238db-4388-49bb-aa67-6d73adbb22801
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDe3e238db-4388-49bb-aa67-6d73adbb22801
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCDe3e238db-4388-49bb-aa67-6d73adbb22801
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDe3e238db-4388-49bb-aa67-6d73adbb22801
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYe3e238db-4388-49bb-aa67-6d73adbb22801
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSYe3e238db-4388-49bb-aa67-6d73adbb22801
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYe3e238db-4388-49bb-aa67-6d73adbb22801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
46708-793-304670807933030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-793-30) 2024-06-10NoNoCurrent
46708-793-3146708079331100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-793-31) 2024-06-10NoNoCurrent
46708-793-7146708079371500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-793-71) 2024-06-10NoNoCurrent
46708-793-904670807939090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-793-90) 2024-06-10NoNoCurrent
46708-793-91467080793911000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-793-91) 2024-06-10NoNoCurrent