Warfarin Sodium

Product NDC
70518-2380
11-digit product format
705182380
Labeler code
70518
Product ID
70518-2380_50ad0d9b-c45b-ed1b-e063-6394a90aab59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Warfarin
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202202
Marketing category
ANDA
Marketing start
2019-10-23
Substance
WARFARIN SODIUM
Active strength
3 mg/1
Pharmacologic classes
Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Warfarin Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WARFARIN SODIUM3 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6153CWM0CL
Rxcui855318

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
abcfe2f4-1eca-fdc3-341b-b8134a1aec1fProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2380-02023-03-09C16284748780-1f386c64a-1a8b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets (crystalline), for oral use Initial U.S. Approval: 1954
70518-2380-02023-03-09C16284748780-1f386c64a-1a8b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets (crystalline), for oral use Initial U.S. Approval: 1954
70518-2380-02023-03-09C16284748780-1f386c64a-1a8b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets (crystalline), for oral use Initial U.S. Approval: 1954
70518-2380-02023-01-30C16284748780-1f386c64a-1a8b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets (crystalline), for oral use Initial U.S. Approval: 1954
70518-2380-02023-01-30C16284748780-1f386c64a-1a8b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets (crystalline), for oral use Initial U.S. Approval: 1954
70518-2380-02023-01-30C16284748780-1f386c64a-1a8b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets (crystalline), for oral use Initial U.S. Approval: 1954

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2380-0Warfarin Sodium100 in 1 BOXTABLET1007
70518-2380-1Warfarin Sodium1 in 1 POUCHTABLET17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855318warfarin sodium 3 MG Oral TabletPSN884cdbf6-0a52-4126-8e14-b0d7c9367e337
855318warfarin sodium 3 MG Oral TabletSCD884cdbf6-0a52-4126-8e14-b0d7c9367e337

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2380-070518238000100 POUCH in 1 BOX (70518-2380-0) / 1 TABLET in 1 POUCH (70518-2380-1) 100 pouch2019-10-230000-00-00NoNoCurrent
70518-2380-1705182380011 in 1 POUCHHistorical