FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
70518-2259
11-digit product format
705182259
Labeler code
70518
Product ID
70518-2259_49ef8066-9ca5-1d82-e063-6394a90a74a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA200834
Marketing category
ANDA
Marketing start
2019-08-09
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
150 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 HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui313581

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
70518-2259-0Venlafaxine Hydrochloride90 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE9015
70518-2259-1Venlafaxine Hydrochloride90 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE9015
70518-2259-2Venlafaxine Hydrochloride30 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE3015
70518-2259-3Venlafaxine Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE3015
70518-2259-4Venlafaxine Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE3015
70518-2259-5Venlafaxine Hydrochloride30 in 1 BOXCAPSULE, EXTENDED RELEASE3015
70518-2259-6Venlafaxine Hydrochloride1 in 1 POUCHCAPSULE, EXTENDED RELEASE115
70518-2259-7Venlafaxine Hydrochloride60 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE6015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2259VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REMEDYREPACK INC.]12Current NDC, Legacy NDC, 8 package rows20250309_50d3b487-9f65-4e2f-b6eb-9533964f8972.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN50d3b487-9f65-4e2f-b6eb-9533964f897215
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD50d3b487-9f65-4e2f-b6eb-9533964f897215
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY50d3b487-9f65-4e2f-b6eb-9533964f897215

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2259-07051822590090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-2259-0) 2019-08-090000-00-00NoNoCurrent
70518-2259-17051822590190 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-2259-1) 2020-08-190000-00-00NoNoCurrent
70518-2259-27051822590230 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70518-2259-2) 2020-11-020000-00-00NoNoCurrent
70518-2259-37051822590330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-2259-3) 2020-12-230000-00-00NoNoCurrent
70518-2259-47051822590430 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-2259-4) 2021-11-010000-00-00NoNoCurrent
70518-2259-57051822590530 POUCH in 1 BOX (70518-2259-5) / 1 CAPSULE, EXTENDED RELEASE in 1 POUCH (70518-2259-6) 30 pouch2023-08-28NoNoHistorical
70518-2259-6705182259061 in 1 POUCHHistorical
70518-2259-77051822590760 in 1 BOTTLE, PLASTICHistorical