FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
70710-1698
11-digit product format
707101698
Labeler code
70710
Product ID
70710-1698_9d291423-f1d9-4605-af7c-f18537aa8914
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA090174
Marketing category
ANDA
Marketing start
2023-05-18
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Venlafaxine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE37.5 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
70710-1698-0Venlafaxine Hydrochloride1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE10003
70710-1698-2Venlafaxine Hydrochloride10 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE103
70710-1698-3Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE303
70710-1698-4Venlafaxine Hydrochloride10 in 1 CARTONCAPSULE, EXTENDED RELEASE103
70710-1698-5Venlafaxine Hydrochloride500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5003
70710-1698-9Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1698VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]2Current NDC, 6 package rows20230905_9fda0f8d-b24e-4581-9dca-7aaaf86e2413.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN9fda0f8d-b24e-4581-9dca-7aaaf86e24133
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN9fda0f8d-b24e-4581-9dca-7aaaf86e24133
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN9fda0f8d-b24e-4581-9dca-7aaaf86e24133
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD9fda0f8d-b24e-4581-9dca-7aaaf86e24133
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD9fda0f8d-b24e-4581-9dca-7aaaf86e24133
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD9fda0f8d-b24e-4581-9dca-7aaaf86e24133
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY9fda0f8d-b24e-4581-9dca-7aaaf86e24133
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY9fda0f8d-b24e-4581-9dca-7aaaf86e24133
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY9fda0f8d-b24e-4581-9dca-7aaaf86e24133

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70710-1698-0707101698001000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1698-0) 2023-05-18NoNoCurrent
70710-1698-27071016980210 in 1 BLISTER PACKHistorical
70710-1698-37071016980330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1698-3) 2023-05-18NoNoCurrent
70710-1698-47071016980410 BLISTER PACK in 1 CARTON (70710-1698-4) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70710-1698-2) 10 blister pack2023-05-18NoNoCurrent
70710-1698-570710169805500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1698-5) 2023-05-18NoNoCurrent
70710-1698-97071016980990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1698-9) 2023-05-18NoNoCurrent