VENLAFAXINE HYDROCHLORIDE

Product NDC
64679-716
11-digit product format
646790716
Labeler code
64679
Product ID
64679-716_b774f3ed-bdf1-c825-e053-2995a90a6e10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VENLAFAXINE HYDROCHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Wockhardt USA LLC.
Application
ANDA078865
Marketing category
ANDA
Marketing start
2011-04-14
Marketing end
0000-00-00
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
38 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64679-716-01EA - Each64679-716d552e60b-df83-44b3-9ac1-032c05c1974e12012-07-24
64679-716-04EA - Each64679-716af01202c-5772-40a3-92fe-a914f9e2d58412012-07-24
64679-716-05EA - Each64679-716d0efe15a-0943-484b-ba27-08bdc11153ce12012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64679-716VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [WOCKHARDT USA LLC.]7Legacy NDC20201228_e0990ade-320e-4259-8c0e-6d5ef23bc673.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64679-716-016467907160130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64679-716-01) 2011-04-140000-00-00NoNoCurrent
64679-716-02646790716021000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64679-716-02) 2011-04-140000-00-00NoNoCurrent
64679-716-036467907160316 BLISTER PACK in 1 CARTON (64679-716-03) > 8 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK16 blister pack2011-04-140000-00-00NoNoCurrent
64679-716-046467907160490 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64679-716-04) 2011-04-140000-00-00NoNoCurrent
64679-716-0564679071605500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64679-716-05) 2011-04-140000-00-00NoNoCurrent