FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
68084-709
11-digit product format
680840709
Labeler code
68084
Product ID
68084-709_38559313-5695-06b2-e063-6394a90a92f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA200834
Marketing category
ANDA
Marketing start
2014-06-03
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
Rxcui313581, 313583, 313585

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
68084-709-01Venlafaxine Hydrochloride100 in 1 BOX, UNIT-DOSECAPSULE, EXTENDED RELEASE10012
68084-709-11Venlafaxine Hydrochloride1 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-709-01EA - Each68084-709969f4abe-81f8-4a12-9dda-d541f758e11912014-06-03
68084-709-11EA - Each68084-70987d020f2-32ee-45dc-a68a-3850447548a212014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
ETHYLCELLULOSE (20 MPA.S)INACTIVE INGREDIENTBJG0S321QYVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
GELATININACTIVE INGREDIENT2G86QN327LVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
SHELLACINACTIVE INGREDIENT46N107B71OVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
SUCROSEINACTIVE INGREDIENTC151H8M554VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
TALCINACTIVE INGREDIENT7SEV7J4R1UVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-709VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]11Current NDC, Legacy NDC, 2 package rows20241129_e05bdeb4-07a9-441e-901b-f2aea550db2b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNe05bdeb4-07a9-441e-901b-f2aea550db2b12
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSNe05bdeb4-07a9-441e-901b-f2aea550db2b12
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNe05bdeb4-07a9-441e-901b-f2aea550db2b12
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDe05bdeb4-07a9-441e-901b-f2aea550db2b12
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCDe05bdeb4-07a9-441e-901b-f2aea550db2b12
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDe05bdeb4-07a9-441e-901b-f2aea550db2b12
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYe05bdeb4-07a9-441e-901b-f2aea550db2b12
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSYe05bdeb4-07a9-441e-901b-f2aea550db2b12
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYe05bdeb4-07a9-441e-901b-f2aea550db2b12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-709-0168084070901100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-709-01) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68084-709-11) 100 blister pack2014-06-030000-00-00NoNoCurrent
68084-709-11680840709111 in 1 BLISTER PACKHistorical