FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
68071-2393
11-digit product format
680712393
Labeler code
68071
Product ID
68071-2393_4c5024ab-1b0e-d145-e063-6394a90a911a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA212277
Marketing category
ANDA
Marketing start
2019-07-08
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
Rxcui313583

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
68071-2393-32025-01-30C16284748780-12cef2736-b5e5-d83d-e063-dadaa90ab31fThese 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
68071-2393-3Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2393VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NUCARE PHARMACEUTICALS,INC.]2Current NDC, Legacy NDC, 1 package rows20220123_c0fa9a3b-692e-2c2e-e053-2995a90aa83a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSNc0fa9a3b-692e-2c2e-e053-2995a90aa83a3
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCDc0fa9a3b-692e-2c2e-e053-2995a90aa83a3
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSYc0fa9a3b-692e-2c2e-e053-2995a90aa83a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2393-36807123930330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68071-2393-3) 2021-04-270000-00-00NoNoCurrent