FDA.reportPublic FDA data

Warfarin Sodium

Product NDC
51138-061
11-digit product format
511380061
Labeler code
51138
Product ID
51138-061_e2447944-15e9-4074-aff0-2c90a7c04694
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
warfarin sodium
Dosage form
TABLET
Route
ORAL
Labeler
Med-Health Pharma, LLC
Application
ANDA040301
Marketing category
ANDA
Marketing start
2011-02-09
Marketing end
0000-00-00
Substance
WARFARIN SODIUM
Active strength
8 mg/1
Pharmacologic classes
Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
51138-061-302019-11-13C16284748780-197449f38-c58d-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use warfarin sodium safely and effectively. See full prescribing information for warfarin sodium. Warfarin Sodium Tablets USP, for oral use Initial U.S. Approval: 1954

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51138-061-30Warfarin Sodium30 in 1 BOTTLE, PLASTICTABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51138-061-30EA - Each51138-061262813e1-b9d7-40ad-a3be-e7189387abf012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Warfarin SodiumACTIVE INGREDIENT6153CWM0CLWARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]2
WarfarinACTIVE MOIETY5Q7ZVV76EIWARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]2
Aluminum OxideINACTIVE INGREDIENTLMI26O6933WARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]2
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKWARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]2
Barium OxideINACTIVE INGREDIENT77603K202BWARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]2
D&C Red No. 6INACTIVE INGREDIENT481744AI4OWARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]2
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GWARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]2
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDWARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]2
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKWARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]2
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOAWARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]2
magnesium stearateINACTIVE INGREDIENT70097M6I30WARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]2
starch, cornINACTIVE INGREDIENTO8232NY3SJWARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51138-061WARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]2Legacy NDC, 1 package rows20120208_b1b766b1-0327-48cd-ab01-e85038cf365f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855288warfarin sodium 1 MG Oral TabletPSNb1b766b1-0327-48cd-ab01-e85038cf365f2
855296warfarin sodium 10 MG Oral TabletPSNb1b766b1-0327-48cd-ab01-e85038cf365f2
855302warfarin sodium 2 MG Oral TabletPSNb1b766b1-0327-48cd-ab01-e85038cf365f2
855312warfarin sodium 2.5 MG Oral TabletPSNb1b766b1-0327-48cd-ab01-e85038cf365f2
855318warfarin sodium 3 MG Oral TabletPSNb1b766b1-0327-48cd-ab01-e85038cf365f2
855324warfarin sodium 4 MG Oral TabletPSNb1b766b1-0327-48cd-ab01-e85038cf365f2
855332warfarin sodium 5 MG Oral TabletPSNb1b766b1-0327-48cd-ab01-e85038cf365f2
855338warfarin sodium 6 MG Oral TabletPSNb1b766b1-0327-48cd-ab01-e85038cf365f2
855344warfarin sodium 7.5 MG Oral TabletPSNb1b766b1-0327-48cd-ab01-e85038cf365f2
855288warfarin sodium 1 MG Oral TabletSCDb1b766b1-0327-48cd-ab01-e85038cf365f2
855296warfarin sodium 10 MG Oral TabletSCDb1b766b1-0327-48cd-ab01-e85038cf365f2
855302warfarin sodium 2 MG Oral TabletSCDb1b766b1-0327-48cd-ab01-e85038cf365f2
855312warfarin sodium 2.5 MG Oral TabletSCDb1b766b1-0327-48cd-ab01-e85038cf365f2
855318warfarin sodium 3 MG Oral TabletSCDb1b766b1-0327-48cd-ab01-e85038cf365f2
855324warfarin sodium 4 MG Oral TabletSCDb1b766b1-0327-48cd-ab01-e85038cf365f2
855332warfarin sodium 5 MG Oral TabletSCDb1b766b1-0327-48cd-ab01-e85038cf365f2
855338warfarin sodium 6 MG Oral TabletSCDb1b766b1-0327-48cd-ab01-e85038cf365f2
855344warfarin sodium 7.5 MG Oral TabletSCDb1b766b1-0327-48cd-ab01-e85038cf365f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
51138-061-305113800613030 in 1 BOTTLE, PLASTICHistorical