FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
63187-481
11-digit product format
631870481
Labeler code
63187
Product ID
63187-481_e9619c8b-343a-468e-9eb1-9f6a0be2b1f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076565
Marketing category
ANDA
Marketing start
2010-07-01
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
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 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-481-30Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE308
63187-481-60Venlafaxine Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE608
63187-481-90Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-481-30EA - Each63187-481c121c039-4196-4712-a840-2bc41d298f2312019-08-06
63187-481-60EA - Each63187-481b099e36f-e187-4391-97ef-36fbae9155dd12021-03-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
DIBUTYL SEBACATEINACTIVE INGREDIENT4W5IH7FLNYVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
ETHYLCELLULOSE (7 MPA.S)INACTIVE INGREDIENTH3UP11403CVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
GELATININACTIVE INGREDIENT2G86QN327LVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
SHELLACINACTIVE INGREDIENT46N107B71OVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
SUCROSEINACTIVE INGREDIENTC151H8M554VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-481VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]8Current NDC, Legacy NDC, 3 package rows20241031_adeba7dd-bd15-4d8f-b703-24c3a208e740.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSNadeba7dd-bd15-4d8f-b703-24c3a208e7408
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCDadeba7dd-bd15-4d8f-b703-24c3a208e7408
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSYadeba7dd-bd15-4d8f-b703-24c3a208e7408

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-481-306318704813030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63187-481-30) 2015-05-010000-00-00NoNoCurrent
63187-481-606318704816060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63187-481-60) 2015-05-010000-00-00NoNoCurrent
63187-481-906318704819090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63187-481-90) 2015-05-010000-00-00NoNoCurrent