VENLAFAXINE HYDROCHLORIDE

Product NDC
55648-717
11-digit product format
556480717
Labeler code
55648
Product ID
55648-717_cd51dc6a-6737-49ce-b330-bb8cd16d8542
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VENLAFAXINE HYDROCHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Wockhardt Limited
Application
ANDA078865
Marketing category
ANDA
Marketing start
2011-04-14
Marketing end
0000-00-00
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
75 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-717-01VENLAFAXINE HYDROCHLORIDE30 in 1 BOTTLECAPSULE, EXTENDED RELEASE303
55648-717-02VENLAFAXINE HYDROCHLORIDE1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE10003
55648-717-03VENLAFAXINE HYDROCHLORIDE8 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE83
55648-717-03VENLAFAXINE HYDROCHLORIDE16 in 1 CARTONCAPSULE, EXTENDED RELEASE163
55648-717-04VENLAFAXINE HYDROCHLORIDE90 in 1 BOTTLECAPSULE, EXTENDED RELEASE903
55648-717-05VENLAFAXINE HYDROCHLORIDE500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5003

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [WOCKHARDT LIMITED]3
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [WOCKHARDT LIMITED]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [WOCKHARDT LIMITED]3
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [WOCKHARDT LIMITED]3
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [WOCKHARDT LIMITED]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [WOCKHARDT LIMITED]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [WOCKHARDT LIMITED]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [WOCKHARDT LIMITED]3
GELATININACTIVE INGREDIENT2G86QN327LVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [WOCKHARDT LIMITED]3
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [WOCKHARDT LIMITED]3
POVIDONE K30INACTIVE INGREDIENTU725QWY32XVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [WOCKHARDT LIMITED]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [WOCKHARDT LIMITED]3
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [WOCKHARDT LIMITED]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [WOCKHARDT LIMITED]3
TALCINACTIVE INGREDIENT7SEV7J4R1UVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [WOCKHARDT LIMITED]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [WOCKHARDT LIMITED]3
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [WOCKHARDT LIMITED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-717VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [WOCKHARDT LIMITED]3Legacy NDC, 6 package rows20140221_c32ccd4d-77b4-4451-8c03-ffc6484bc1f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNc32ccd4d-77b4-4451-8c03-ffc6484bc1f33
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSNc32ccd4d-77b4-4451-8c03-ffc6484bc1f33
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNc32ccd4d-77b4-4451-8c03-ffc6484bc1f33
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDc32ccd4d-77b4-4451-8c03-ffc6484bc1f33
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCDc32ccd4d-77b4-4451-8c03-ffc6484bc1f33
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDc32ccd4d-77b4-4451-8c03-ffc6484bc1f33
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYc32ccd4d-77b4-4451-8c03-ffc6484bc1f33
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSYc32ccd4d-77b4-4451-8c03-ffc6484bc1f33
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYc32ccd4d-77b4-4451-8c03-ffc6484bc1f33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-717-015564807170130 in 1 BOTTLEHistorical
55648-717-02556480717021000 in 1 BOTTLEHistorical
55648-717-03556480717038 in 1 BLISTER PACKHistorical
55648-717-045564807170490 in 1 BOTTLEHistorical
55648-717-0555648071705500 in 1 BOTTLEHistorical