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FDA Drug information

Warfarin Sodium

Read time: 1 mins
Marketing start date: 27 Apr 2024
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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

65841-056

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

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Disclaimer

The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).

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Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.