VENLAFAXINE HYDROCHLORIDE

Product NDC
10135-827
11-digit product format
101350827
Labeler code
10135
Product ID
10135-827_3d59e057-318b-f098-e063-6394a90a25be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VENLAFAXINE HYDROCHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Marlex Pharmaceuticals, Inc.
Application
ANDA201272
Marketing category
ANDA
Marketing start
2025-08-01
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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
7D7RX5A8MOVENLAFAXINE HYDROCHLORIDE99300-78-4VENLAFAXINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
10135-827-10101350827101000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10135-827-10) 2025-08-01NoNoHistorical
10135-827-301013508273030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10135-827-30) 2025-08-01NoNoHistorical
10135-827-751013508277515 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10135-827-75) 2025-08-01NoNoHistorical
10135-827-901013508279090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10135-827-90) 2025-08-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
VENLAFAXINE HYDROCHLORIDEMarlex Pharmaceuticals, Inc.2025-08-01HUMAN PRESCRIPTION DRUG LABEL2