FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
70518-2532
11-digit product format
705182532
Labeler code
70518
Product ID
70518-2532_4a65d321-8f96-e5b9-e063-6294a90a6316
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
2020-01-08
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
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
70518-2532-0Venlafaxine Hydrochloride30 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE3015
70518-2532-1Venlafaxine Hydrochloride30 in 1 BOXCAPSULE, EXTENDED RELEASE3015
70518-2532-2Venlafaxine Hydrochloride1 in 1 POUCHCAPSULE, EXTENDED RELEASE115
70518-2532-3Venlafaxine Hydrochloride30 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE3015
70518-2532-4Venlafaxine Hydrochloride30 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE3015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2532VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REMEDYREPACK INC.]13Current NDC, Legacy NDC, 5 package rows20250321_4e3053b9-cdec-4f4d-85ae-2e55cf1cc185.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN4e3053b9-cdec-4f4d-85ae-2e55cf1cc18515
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD4e3053b9-cdec-4f4d-85ae-2e55cf1cc18515
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY4e3053b9-cdec-4f4d-85ae-2e55cf1cc18515

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2532-07051825320030 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70518-2532-0) 2020-01-080000-00-00NoNoCurrent
70518-2532-17051825320130 POUCH in 1 BOX (70518-2532-1) / 1 CAPSULE, EXTENDED RELEASE in 1 POUCH (70518-2532-2) 30 pouch2023-08-26NoNoHistorical
70518-2532-2705182532021 in 1 POUCHHistorical
70518-2532-37051825320330 in 1 BLISTER PACKHistorical
70518-2532-47051825320430 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70518-2532-4) 2023-12-07NoNoHistorical