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Warfarin sodium - Medication Information

Product NDC Code 65841-052
Drug Name

Warfarin sodium

Type Generic
Pharm Class Vitamin K Antagonist [EPC],
Vitamin K Inhibitors [MoA]
Active Ingredients
Warfarin sodium 1 mg/1
Route ORAL
Dosage Form TABLET
RxCUI drug identifier 855288,
855296,
855302,
855312,
855318,
855324,
855332,
855338,
855344
Application Number ANDA040663
Labeler Name Zydus Lifesciences Limited
Packages
Package NDC Code Description
65841-052-01 100 tablet in 1 bottle (65841-052-01)
65841-052-10 1000 tablet in 1 bottle (65841-052-10)
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Spl product data elements

Usually a list of ingredients in a drug product.
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

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
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

Spl medguide

Information about the patient medication guide that accompanies the drug product. Certain drugs must be dispensed with an accompanying medication guide. This field may contain information about when to consult the medication guide and the contents of the medication guide.
SPL MEDGUIDE

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API