FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
70518-2107
11-digit product format
705182107
Labeler code
70518
Product ID
70518-2107_499ef330-088a-7248-e063-6394a90af248
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
2019-05-23
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
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 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
70518-2107-0Venlafaxine Hydrochloride30 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE3017
70518-2107-1Venlafaxine Hydrochloride30 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE3017
70518-2107-2Venlafaxine Hydrochloride90 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE9017
70518-2107-3Venlafaxine Hydrochloride30 in 1 BOXCAPSULE, EXTENDED RELEASE3017
70518-2107-4Venlafaxine Hydrochloride1 in 1 POUCHCAPSULE, EXTENDED RELEASE117
70518-2107-5Venlafaxine Hydrochloride30 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE3017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2107VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REMEDYREPACK INC.]14Current NDC, Legacy NDC, 6 package rows20250306_ac9b972d-8b8a-4727-90c2-b208f91272fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNac9b972d-8b8a-4727-90c2-b208f91272fd17
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDac9b972d-8b8a-4727-90c2-b208f91272fd17
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYac9b972d-8b8a-4727-90c2-b208f91272fd17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2107-07051821070030 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70518-2107-0) 2019-05-230000-00-00NoNoCurrent
70518-2107-17051821070130 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70518-2107-1) 2020-08-310000-00-00NoNoCurrent
70518-2107-27051821070290 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-2107-2) 2022-02-170000-00-00NoNoCurrent
70518-2107-37051821070330 POUCH in 1 BOX (70518-2107-3) / 1 CAPSULE, EXTENDED RELEASE in 1 POUCH (70518-2107-4) 30 pouch2023-08-26NoNoHistorical
70518-2107-4705182107041 in 1 POUCHHistorical
70518-2107-57051821070530 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70518-2107-5) 2025-07-31NoNoHistorical