Warfarin Sodium
Summary of product characteristics
Effective Time
20231003
Version
8
Spl Product Data Elements
Warfarin Sodium Warfarin Sodium WARFARIN SODIUM WARFARIN D&C RED NO. 6 BARIUM LAKE HYDROXYPROPYL CELLULOSE (1600000 WAMW) LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, CORN PINK OVAL WAR;1 Warfarin Sodium Warfarin Sodium WARFARIN SODIUM WARFARIN FD&C BLUE NO. 2--ALUMINUM LAKE HYDROXYPROPYL CELLULOSE (1600000 WAMW) LACTOSE MONOHYDRATE MAGNESIUM STEARATE FD&C RED NO. 40 STARCH, CORN ALUMINUM OXIDE LAVENDER OVAL WAR;2 Warfarin Sodium Warfarin Sodium WARFARIN SODIUM WARFARIN ALUMINUM OXIDE D&C YELLOW NO. 10 FD&C BLUE NO. 1--ALUMINUM LAKE HYDROXYPROPYL CELLULOSE (1600000 WAMW) LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, CORN GREEN OVAL WAR;2;1;2 Warfarin Sodium Warfarin Sodium WARFARIN SODIUM WARFARIN ALUMINUM OXIDE FD&C BLUE NO. 2--ALUMINUM LAKE FD&C RED NO. 40 FD&C YELLOW NO. 6 HYDROXYPROPYL CELLULOSE (1600000 WAMW) LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, CORN TAN OVAL WAR;3 Warfarin Sodium Warfarin Sodium WARFARIN SODIUM WARFARIN FD&C BLUE NO. 1--ALUMINUM LAKE HYDROXYPROPYL CELLULOSE (1600000 WAMW) LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, CORN BLUE OVAL WAR;4 Warfarin Sodium Warfarin Sodium WARFARIN SODIUM WARFARIN ALUMINUM OXIDE FD&C YELLOW NO. 6 HYDROXYPROPYL CELLULOSE (1600000 WAMW) LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, CORN PEACH OVAL WAR;5 Warfarin Sodium Warfarin Sodium WARFARIN SODIUM WARFARIN FD&C BLUE NO. 1--ALUMINUM LAKE FD&C YELLOW NO. 6 HYDROXYPROPYL CELLULOSE (1600000 WAMW) LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, CORN ALUMINUM OXIDE TEAL OVAL WAR;6 Warfarin Sodium Warfarin Sodium WARFARIN SODIUM WARFARIN ALUMINUM OXIDE D&C YELLOW NO. 10 FD&C YELLOW NO. 6 HYDROXYPROPYL CELLULOSE (1600000 WAMW) LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, CORN YELLOW OVAL WAR;7;1;2 Warfarin Sodium Warfarin Sodium WARFARIN SODIUM WARFARIN HYDROXYPROPYL CELLULOSE (1600000 WAMW) LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, CORN WHITE TO OFF-WHITE OVAL WAR;10
Application Number
ANDA040663
Brand Name
Warfarin Sodium
Generic Name
Warfarin Sodium
Product Ndc
65841-055
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Package Label Principal Display Panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-052-01 in bottle of 100 tablets Warfarin Sodium Tablets USP, 1 mg R x only 100 tablets NDC 65841-053-01 in bottle of 100 tablets Warfarin Sodium Tablets USP, 2 mg R x only 100 tablets NDC 65841-064-01 in bottle of 100 tablets Warfarin Sodium Tablets USP, 2.5 mg R x only 100 tablets NDC 65841-054-01 in bottle of 100 tablets Warfarin Sodium Tablets USP, 3 mg R x only 100 tablets NDC 65841-055-01 in bottle of 100 tablets Warfarin Sodium Tablets USP, 4 mg R x only 100 tablets NDC 65841-056-01 in bottle of 100 tablets Warfarin Sodium Tablets USP, 5 mg R x only 100 tablets NDC 65841-057-01 in bottle of 100 tablets Warfarin Sodium Tablets USP, 6 mg R x only 100 tablets NDC 65841-058-01 in bottle of 100 tablets Warfarin Sodium Tablets USP, 7.5 mg R x only 100 tablets NDC 65841-059-01 in bottle of 100 tablets Warfarin Sodium Tablets USP, 10 mg R x only 100 tablets Warfarin sodium tablets Warfarin Sodium tablet Warfarin Sodium tablets Warfarin Sodium tablets warfarin sodium tablet warfarin sodium tablet warfarin sodium tablet warfarin sodium tablet warfarin sodium tablet
150 mins
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