FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
63187-177
11-digit product format
631870177
Labeler code
63187
Product ID
63187-177_264c4e5f-62fa-4c63-b79b-796b5a7f1a7d
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-177-30Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE307
63187-177-60Venlafaxine Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE607
63187-177-90Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-177-30EA - Each63187-177efa44812-3b93-4c63-8a21-3f8c7e008bd012018-10-11
63187-177-60EA - Each63187-177f4ac8674-dafa-44fa-8fec-c9e21b3f11a512023-08-08
63187-177-90EA - Each63187-177b693f4c1-add9-4a33-92ff-c91dfa27feb612019-04-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]2
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]2
DIBUTYL SEBACATEINACTIVE INGREDIENT4W5IH7FLNYVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]2
ETHYLCELLULOSE (7 MPA.S)INACTIVE INGREDIENTH3UP11403CVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]2
GELATININACTIVE INGREDIENT2G86QN327LVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]2
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]2
SHELLACINACTIVE INGREDIENT46N107B71OVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]2
SUCROSEINACTIVE INGREDIENTC151H8M554VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]2
TALCINACTIVE INGREDIENT7SEV7J4R1UVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-177VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]7Current NDC, Legacy NDC, 3 package rows20241024_9f697c00-f5ec-454a-a66c-503aef5fc609.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN9f697c00-f5ec-454a-a66c-503aef5fc6097
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD9f697c00-f5ec-454a-a66c-503aef5fc6097
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY9f697c00-f5ec-454a-a66c-503aef5fc6097

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-177-306318701773030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63187-177-30) 2014-09-010000-00-00NoNoCurrent
63187-177-606318701776060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63187-177-60) 2014-09-010000-00-00NoNoCurrent
63187-177-906318701779090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63187-177-90) 2014-09-010000-00-00NoNoCurrent