FDA.reportPublic FDA data

Warfarin Sodium

Product NDC
71610-448
11-digit product format
716100448
Labeler code
71610
Product ID
71610-448_c6ed46d9-0050-4c67-9a18-378ab6bf3ab3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Warfarin
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA090935
Marketing category
ANDA
Marketing start
2011-05-25
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
71610-448-11Warfarin Sodium48 in 1 BOTTLETABLET481
71610-448-15Warfarin Sodium15 in 1 BOTTLETABLET151
71610-448-20Warfarin Sodium20 in 1 BOTTLETABLET201
71610-448-21Warfarin Sodium32 in 1 BOTTLETABLET321
71610-448-25Warfarin Sodium25 in 1 BOTTLETABLET251
71610-448-28Warfarin Sodium28 in 1 BOTTLETABLET281
71610-448-30Warfarin Sodium30 in 1 BOTTLETABLET301
71610-448-35Warfarin Sodium35 in 1 BOTTLETABLET351
71610-448-38Warfarin Sodium55 in 1 BOTTLETABLET551
71610-448-40Warfarin Sodium40 in 1 BOTTLETABLET401
71610-448-44Warfarin Sodium36 in 1 BOTTLETABLET361
71610-448-45Warfarin Sodium45 in 1 BOTTLETABLET451
71610-448-46Warfarin Sodium56 in 1 BOTTLETABLET561
71610-448-47Warfarin Sodium24 in 1 BOTTLETABLET241
71610-448-50Warfarin Sodium50 in 1 BOTTLETABLET501
71610-448-53Warfarin Sodium60 in 1 BOTTLETABLET601
71610-448-55Warfarin Sodium75 in 1 BOTTLETABLET751
71610-448-59Warfarin Sodium22 in 1 BOTTLETABLET221
71610-448-60Warfarin Sodium90 in 1 BOTTLETABLET901
71610-448-61Warfarin Sodium70 in 1 BOTTLETABLET701
71610-448-68Warfarin Sodium26 in 1 BOTTLETABLET261
71610-448-78Warfarin Sodium34 in 1 BOTTLETABLET341

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-448-11EA - Each71610-448f09f5d75-7100-4c7e-8fdd-8761e42f9def12020-09-14
71610-448-15EA - Each71610-448f5357e36-75dc-4cb1-a37f-9ff75995166812020-09-14
71610-448-20EA - Each71610-448671dae9e-2414-465a-9032-ec26b76a8bef12020-09-14
71610-448-21EA - Each71610-4484856d4e1-6b54-42ca-8f83-88ab501a455012020-09-14
71610-448-25EA - Each71610-448e00c4765-758b-43aa-aef3-ed82a236482412020-09-14
71610-448-28EA - Each71610-4485ed2076d-3c3f-4f7b-9108-ec0e1ec8943c12020-09-14
71610-448-30EA - Each71610-44821edc74f-13d6-4fff-9b5d-15391933461212020-09-14
71610-448-38EA - Each71610-448f664eaf6-7273-4e4d-921f-b979c28230e012020-09-14
71610-448-40EA - Each71610-448801c38c5-73a2-4683-abfe-70f44ce8980712020-09-14
71610-448-44EA - Each71610-448ec1b037c-b14e-4852-99a2-850937ee3df512020-09-14
71610-448-45EA - Each71610-4481c98efe3-e7d8-42d7-9cd1-b56cff7ea90012020-09-14
71610-448-46EA - Each71610-448591d5fae-65c7-42d3-ae6b-f889d407516712020-09-14
71610-448-47EA - Each71610-448e8c992a2-79d8-4917-afd8-095e94697ab912020-09-14
71610-448-50EA - Each71610-4489671de02-d6b2-4a1d-98dd-8241a35d4cc012020-09-14
71610-448-53EA - Each71610-448c358ce62-3fef-4eb6-85de-47b648e63e3912020-09-14
71610-448-55EA - Each71610-4486e510403-9778-43b8-b740-b4afc2863ba012020-09-14
71610-448-59EA - Each71610-448c4f7749d-83fb-4b85-aaaf-c3dac36872df12020-09-14
71610-448-60EA - Each71610-448d4db2c83-5dc9-4605-91bb-a5aa61a724cc12020-09-14
71610-448-61EA - Each71610-448e861d528-0e23-49c9-9b66-a66fc2c3fa4412020-09-14
71610-448-68EA - Each71610-448e87b6655-e2b7-45dd-820d-4883bb1e8f9c12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-448WARFARIN SODIUM (WARFARIN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 22 package rows20200806_91f24482-d4cb-4a09-a97e-64f6e49071ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855332warfarin sodium 5 MG Oral TabletPSN91f24482-d4cb-4a09-a97e-64f6e49071ee1
855332warfarin sodium 5 MG Oral TabletSCD91f24482-d4cb-4a09-a97e-64f6e49071ee1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-448-117161004481148 TABLET in 1 BOTTLE (71610-448-11) 48 tablet2020-07-300000-00-00NoNoCurrent
71610-448-157161004481515 TABLET in 1 BOTTLE (71610-448-15) 15 tablet2020-07-300000-00-00NoNoCurrent
71610-448-207161004482020 TABLET in 1 BOTTLE (71610-448-20) 20 tablet2020-07-300000-00-00NoNoCurrent
71610-448-217161004482132 TABLET in 1 BOTTLE (71610-448-21) 32 tablet2020-07-300000-00-00NoNoCurrent
71610-448-257161004482525 TABLET in 1 BOTTLE (71610-448-25) 25 tablet2020-07-300000-00-00NoNoCurrent
71610-448-287161004482828 TABLET in 1 BOTTLE (71610-448-28) 28 tablet2020-07-300000-00-00NoNoCurrent
71610-448-307161004483030 TABLET in 1 BOTTLE (71610-448-30) 30 tablet2020-07-300000-00-00NoNoCurrent
71610-448-357161004483535 TABLET in 1 BOTTLE (71610-448-35) 35 tablet2020-07-300000-00-00NoNoCurrent
71610-448-387161004483855 TABLET in 1 BOTTLE (71610-448-38) 55 tablet2020-07-300000-00-00NoNoCurrent
71610-448-407161004484040 TABLET in 1 BOTTLE (71610-448-40) 40 tablet2020-07-300000-00-00NoNoCurrent
71610-448-447161004484436 TABLET in 1 BOTTLE (71610-448-44) 36 tablet2020-07-300000-00-00NoNoCurrent
71610-448-457161004484545 TABLET in 1 BOTTLE (71610-448-45) 45 tablet2020-07-300000-00-00NoNoCurrent
71610-448-467161004484656 TABLET in 1 BOTTLE (71610-448-46) 56 tablet2020-07-300000-00-00NoNoCurrent
71610-448-477161004484724 TABLET in 1 BOTTLE (71610-448-47) 24 tablet2020-07-300000-00-00NoNoCurrent
71610-448-507161004485050 TABLET in 1 BOTTLE (71610-448-50) 50 tablet2020-07-300000-00-00NoNoCurrent
71610-448-537161004485360 TABLET in 1 BOTTLE (71610-448-53) 60 tablet2020-07-300000-00-00NoNoCurrent
71610-448-557161004485575 TABLET in 1 BOTTLE (71610-448-55) 75 tablet2020-07-300000-00-00NoNoCurrent
71610-448-597161004485922 TABLET in 1 BOTTLE (71610-448-59) 22 tablet2020-07-300000-00-00NoNoCurrent
71610-448-607161004486090 TABLET in 1 BOTTLE (71610-448-60) 90 tablet2020-07-300000-00-00NoNoCurrent
71610-448-617161004486170 TABLET in 1 BOTTLE (71610-448-61) 70 tablet2020-07-300000-00-00NoNoCurrent
71610-448-687161004486826 TABLET in 1 BOTTLE (71610-448-68) 26 tablet2020-07-300000-00-00NoNoCurrent
71610-448-787161004487834 TABLET in 1 BOTTLE (71610-448-78) 34 tablet2020-07-300000-00-00NoNoCurrent