Venlafaxine Hydrochloride

Product NDC
0904-7488
11-digit product format
009047488
Labeler code
0904
Product ID
0904-7488_d962f5af-7642-4c6e-b7be-3e089fe48873
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA200834
Marketing category
ANDA
Marketing start
2025-10-08
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
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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7488-6100904748861100 BLISTER PACK in 1 CARTON (0904-7488-61) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK100 blister pack2025-10-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Venlafaxine HydrochlorideCardinal Health 107, LLC2026-03-23HUMAN PRESCRIPTION DRUG LABEL1
Venlafaxine HydrochlorideMajor Pharmaceuticals2025-10-08HUMAN PRESCRIPTION DRUG LABEL1