FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
68071-4897
11-digit product format
680714897
Labeler code
68071
Product ID
68071-4897_275d090e-fffd-eb91-e063-6294a90a8ddd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA200834
Marketing category
ANDA
Marketing start
2011-06-01
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
Rxcui313585

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4897-32024-06-14C16284748780-1ba0f9c33-1cac-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. VENLAFAXINE HYDROCHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1997
68071-4897-32023-01-30C16284748780-1ba0f9c33-1cac-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. VENLAFAXINE HYDROCHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1997
68071-4897-32021-02-17C16284748780-1ba0f9c33-1cac-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. VENLAFAXINE HYDROCHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1997
68071-4897-32021-01-29C16284748780-1ba0f9c33-1cac-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. VENLAFAXINE HYDROCHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4897-3Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4897VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 1 package rows20241122_8906ed5a-f69c-0eac-e053-2995a90ae600.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN8906ed5a-f69c-0eac-e053-2995a90ae6004
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD8906ed5a-f69c-0eac-e053-2995a90ae6004
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY8906ed5a-f69c-0eac-e053-2995a90ae6004

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4897-36807148970330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68071-4897-3) 2019-05-160000-00-00NoNoCurrent