FDA.reportPublic FDA data

Warfarin Sodium

Product NDC
70518-2382
11-digit product format
705182382
Labeler code
70518
Product ID
70518-2382_4d5f7647-df9a-fb4f-e063-6294a90a0ee7
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
5 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 SODIUM5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6153CWM0CL
Rxcui855332

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
70518-2382-02023-03-09C16284748780-1f386c64a-2a85-0266-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
70518-2382-02023-03-09C16284748780-1f386c64a-2a85-0266-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
70518-2382-02023-01-30C16284748780-1f386c64a-2a85-0266-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
70518-2382-02023-01-30C16284748780-1f386c64a-2a85-0266-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
70518-2382-0Warfarin Sodium100 in 1 BOXTABLET10012
70518-2382-1Warfarin Sodium1 in 1 POUCHTABLET112
70518-2382-2Warfarin Sodium90 in 1 BOTTLE, PLASTICTABLET9012
70518-2382-3Warfarin Sodium30 in 1 BOTTLE, PLASTICTABLET3012
70518-2382-4Warfarin Sodium30 in 1 BLISTER PACKTABLET3012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2382WARFARIN SODIUM (WARFARIN) TABLET [REMEDYREPACK INC.]8Current NDC, Legacy NDC, 5 package rows20250315_8ee94789-72d2-4c42-9dbd-0501e9767d97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855332warfarin sodium 5 MG Oral TabletPSN8ee94789-72d2-4c42-9dbd-0501e9767d9712
855332warfarin sodium 5 MG Oral TabletSCD8ee94789-72d2-4c42-9dbd-0501e9767d9712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2382-070518238200100 POUCH in 1 BOX (70518-2382-0) / 1 TABLET in 1 POUCH (70518-2382-1) 100 pouch2019-10-230000-00-00NoNoCurrent
70518-2382-1705182382011 in 1 POUCHHistorical
70518-2382-27051823820290 TABLET in 1 BOTTLE, PLASTIC (70518-2382-2) 90 tablet2024-02-13NoNoHistorical
70518-2382-37051823820330 in 1 BOTTLE, PLASTICHistorical
70518-2382-47051823820430 TABLET in 1 BLISTER PACK (70518-2382-4) 30 tablet2025-07-31NoNoHistorical