FDA.reportPublic FDA data

Warfarin Sodium

Product NDC
43063-176
11-digit product format
430630176
Labeler code
43063
Product ID
43063-176_39fd1172-a49a-5ea2-e063-6394a90a7e16
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Warfarin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA040616
Marketing category
ANDA
Marketing start
2015-04-07
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Warfarin Sodium
Listing expiration
2026-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43063-176-14Warfarin Sodium14 in 1 BOTTLE, PLASTICTABLET1414
43063-176-30Warfarin Sodium30 in 1 BOTTLE, PLASTICTABLET3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-176-14EA - Each43063-1760444aab9-efdb-4bb8-9fe2-731e3e3507bb12016-03-04
43063-176-30EA - Each43063-1763dffd07f-d939-41b8-8dd4-ba4f8e3c3dcb12017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-176WARFARIN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.]12Current NDC, Legacy NDC, 2 package rows20241019_21255cd5-3c2e-4574-9620-9347d14256b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855332warfarin sodium 5 MG Oral TabletPSN21255cd5-3c2e-4574-9620-9347d14256b314
855332warfarin sodium 5 MG Oral TabletSCD21255cd5-3c2e-4574-9620-9347d14256b314

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-176-144306301761414 TABLET in 1 BOTTLE, PLASTIC (43063-176-14) 14 tablet2016-02-030000-00-00NoNoCurrent
43063-176-304306301763030 TABLET in 1 BOTTLE, PLASTIC (43063-176-30) 30 tablet2017-09-050000-00-00NoNoCurrent