FDA.reportPublic FDA data

Warfarin Sodium

Product NDC
43353-050
11-digit product format
433530050
Labeler code
43353
Product ID
43353-050_b2821ecc-6d75-4ea4-b57c-78ad508fe7e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Warfarin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA040301
Marketing category
ANDA
Marketing start
1999-07-15
Marketing end
0000-00-00
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
2019-12-31
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
43353-050-152020-01-31C16284748780-19d75b9d1-2b11-f424-e053-dadaa90a57ceWarfarin Sodium Tablets, USP Crystalline
43353-050-202020-01-31C16284748780-19d75b9d1-2b11-f424-e053-dadaa90a57ceWarfarin Sodium Tablets, USP Crystalline
43353-050-252020-01-31C16284748780-19d75b9d1-2b11-f424-e053-dadaa90a57ceWarfarin Sodium Tablets, USP Crystalline
43353-050-282020-01-31C16284748780-19d75b9d1-2b11-f424-e053-dadaa90a57ceWarfarin Sodium Tablets, USP Crystalline
43353-050-302020-01-31C16284748780-19d75b9d1-2b11-f424-e053-dadaa90a57ceWarfarin Sodium Tablets, USP Crystalline
43353-050-352020-01-31C16284748780-19d75b9d1-2b11-f424-e053-dadaa90a57ceWarfarin Sodium Tablets, USP Crystalline
43353-050-382020-01-31C16284748780-19d75b9d1-2b11-f424-e053-dadaa90a57ceWarfarin Sodium Tablets, USP Crystalline
43353-050-402020-01-31C16284748780-19d75b9d1-2b11-f424-e053-dadaa90a57ceWarfarin Sodium Tablets, USP Crystalline
43353-050-452020-01-31C16284748780-19d75b9d1-2b11-f424-e053-dadaa90a57ceWarfarin Sodium Tablets, USP Crystalline
43353-050-502020-01-31C16284748780-19d75b9d1-2b11-f424-e053-dadaa90a57ceWarfarin Sodium Tablets, USP Crystalline
43353-050-532020-01-31C16284748780-19d75b9d1-2b11-f424-e053-dadaa90a57ceWarfarin Sodium Tablets, USP Crystalline
43353-050-552020-01-31C16284748780-19d75b9d1-2b11-f424-e053-dadaa90a57ceWarfarin Sodium Tablets, USP Crystalline
43353-050-572020-01-31C16284748780-19d75b9d1-2b11-f424-e053-dadaa90a57ceWarfarin Sodium Tablets, USP Crystalline
43353-050-602020-01-31C16284748780-19d75b9d1-2b11-f424-e053-dadaa90a57ceWarfarin Sodium Tablets, USP Crystalline
43353-050-612020-01-31C16284748780-19d75b9d1-2b11-f424-e053-dadaa90a57ceWarfarin Sodium Tablets, USP Crystalline
43353-050-652020-01-31C16284748780-19d75b9d1-2b11-f424-e053-dadaa90a57ceWarfarin Sodium Tablets, USP Crystalline
43353-050-682020-01-31C16284748780-19d75b9d1-2b11-f424-e053-dadaa90a57ceWarfarin Sodium Tablets, USP Crystalline
43353-050-702020-01-31C16284748780-19d75b9d1-2b11-f424-e053-dadaa90a57ceWarfarin Sodium Tablets, USP Crystalline
43353-050-782020-01-31C16284748780-19d75b9d1-2b11-f424-e053-dadaa90a57ceWarfarin Sodium Tablets, USP Crystalline

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-050-15Warfarin Sodium15 in 1 BOTTLE, PLASTICTABLET152
43353-050-20Warfarin Sodium20 in 1 BOTTLE, PLASTICTABLET202
43353-050-25Warfarin Sodium25 in 1 BOTTLE, PLASTICTABLET252
43353-050-28Warfarin Sodium28 in 1 BOTTLE, PLASTICTABLET282
43353-050-30Warfarin Sodium30 in 1 BOTTLE, PLASTICTABLET302
43353-050-35Warfarin Sodium35 in 1 BOTTLE, PLASTICTABLET352
43353-050-38Warfarin Sodium55 in 1 BOTTLE, PLASTICTABLET552
43353-050-40Warfarin Sodium40 in 1 BOTTLE, PLASTICTABLET402
43353-050-45Warfarin Sodium45 in 1 BOTTLE, PLASTICTABLET452
43353-050-50Warfarin Sodium50 in 1 BOTTLE, PLASTICTABLET502
43353-050-53Warfarin Sodium60 in 1 BOTTLE, PLASTICTABLET602
43353-050-55Warfarin Sodium75 in 1 BOTTLE, PLASTICTABLET752
43353-050-57Warfarin Sodium80 in 1 BOTTLE, PLASTICTABLET802
43353-050-60Warfarin Sodium90 in 1 BOTTLE, PLASTICTABLET902
43353-050-61Warfarin Sodium70 in 1 BOTTLE, PLASTICTABLET702
43353-050-65Warfarin Sodium100 in 1 BOTTLE, PLASTICTABLET1002
43353-050-68Warfarin Sodium26 in 1 BOTTLE, PLASTICTABLET262
43353-050-70Warfarin Sodium120 in 1 BOTTLE, PLASTICTABLET1202
43353-050-78Warfarin Sodium34 in 1 BOTTLE, PLASTICTABLET342

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-050-15EA - Each43353-050238b4a89-9f4e-48d4-82ea-cc37fb57973912013-02-13
43353-050-20EA - Each43353-050c411da8e-eb3e-4afd-a80a-e5809d245a4412013-02-13
43353-050-25EA - Each43353-05049e5c798-6704-4cf5-bef0-d4b132b3d00712013-02-13
43353-050-28EA - Each43353-050b3895594-94ed-4cb3-b018-6459d5c7230412013-02-13
43353-050-30EA - Each43353-05073c6d98c-207d-4b8b-9699-f4fd4cf9c42312013-02-13
43353-050-35EA - Each43353-050e041847f-39d0-404b-9438-e6aac84ffcdc12013-02-13
43353-050-38EA - Each43353-0506d9de161-da6c-45b9-b7cd-f465468a373112013-02-13
43353-050-40EA - Each43353-050e4dc43e8-b25c-490d-8f8a-9eadde4893e712013-02-13
43353-050-45EA - Each43353-0508192640f-be34-468f-926d-a3aaae6561f112013-02-13
43353-050-50EA - Each43353-050234de505-1e1a-4088-aed5-5d9bf6e5a6b412013-02-13
43353-050-53EA - Each43353-050185208d1-4014-46c9-ae74-7d743658ed6e12013-02-13
43353-050-55EA - Each43353-050b4eb4a11-f4c4-4a1d-8b5e-48366eabca5812013-02-13
43353-050-57EA - Each43353-05069a9d5f8-2e34-432a-99b5-ff4dda562e8a12013-02-13
43353-050-60EA - Each43353-0500ac895bf-4463-4494-bec2-8622acd6db1712013-02-13
43353-050-61EA - Each43353-050b97c9ffb-fc53-4169-ae97-6bbdbf1c193f12013-02-13
43353-050-65EA - Each43353-050eeb48361-fb72-41ac-a509-00a7e1bcf42212013-02-13
43353-050-68EA - Each43353-050f85872d7-8929-4eda-964a-7e0e699736c312013-02-13
43353-050-70EA - Each43353-050d1138db6-929c-4fa2-adf7-981a8ea9b8fe12013-02-13
43353-050-78EA - Each43353-050940302a1-3888-4e90-834c-8d3db1803a4c12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
WARFARIN SODIUMACTIVE INGREDIENT6153CWM0CLWARFARIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
WARFARINACTIVE MOIETY5Q7ZVV76EIWARFARIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
Anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKWARFARIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
D&C RED NO. 6INACTIVE INGREDIENT481744AI4OWARFARIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GWARFARIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDWARFARIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKWARFARIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAWARFARIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
magnesium stearateINACTIVE INGREDIENT70097M6I30WARFARIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJWARFARIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-050WARFARIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 19 package rows20140507_c437507c-d308-4aac-aa5e-a54972c7fa95.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855288warfarin sodium 1 MG Oral TabletPSNc437507c-d308-4aac-aa5e-a54972c7fa952
855296warfarin sodium 10 MG Oral TabletPSNc437507c-d308-4aac-aa5e-a54972c7fa952
855312warfarin sodium 2.5 MG Oral TabletPSNc437507c-d308-4aac-aa5e-a54972c7fa952
855318warfarin sodium 3 MG Oral TabletPSNc437507c-d308-4aac-aa5e-a54972c7fa952
855324warfarin sodium 4 MG Oral TabletPSNc437507c-d308-4aac-aa5e-a54972c7fa952
855332warfarin sodium 5 MG Oral TabletPSNc437507c-d308-4aac-aa5e-a54972c7fa952
855338warfarin sodium 6 MG Oral TabletPSNc437507c-d308-4aac-aa5e-a54972c7fa952
855344warfarin sodium 7.5 MG Oral TabletPSNc437507c-d308-4aac-aa5e-a54972c7fa952
855288warfarin sodium 1 MG Oral TabletSCDc437507c-d308-4aac-aa5e-a54972c7fa952
855296warfarin sodium 10 MG Oral TabletSCDc437507c-d308-4aac-aa5e-a54972c7fa952
855312warfarin sodium 2.5 MG Oral TabletSCDc437507c-d308-4aac-aa5e-a54972c7fa952
855318warfarin sodium 3 MG Oral TabletSCDc437507c-d308-4aac-aa5e-a54972c7fa952
855324warfarin sodium 4 MG Oral TabletSCDc437507c-d308-4aac-aa5e-a54972c7fa952
855332warfarin sodium 5 MG Oral TabletSCDc437507c-d308-4aac-aa5e-a54972c7fa952
855338warfarin sodium 6 MG Oral TabletSCDc437507c-d308-4aac-aa5e-a54972c7fa952
855344warfarin sodium 7.5 MG Oral TabletSCDc437507c-d308-4aac-aa5e-a54972c7fa952

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-050-154335300501515 in 1 BOTTLE, PLASTICHistorical
43353-050-204335300502020 in 1 BOTTLE, PLASTICHistorical
43353-050-254335300502525 in 1 BOTTLE, PLASTICHistorical
43353-050-284335300502828 in 1 BOTTLE, PLASTICHistorical
43353-050-304335300503030 in 1 BOTTLE, PLASTICHistorical
43353-050-354335300503535 in 1 BOTTLE, PLASTICHistorical
43353-050-384335300503855 in 1 BOTTLE, PLASTICHistorical
43353-050-404335300504040 in 1 BOTTLE, PLASTICHistorical
43353-050-454335300504545 in 1 BOTTLE, PLASTICHistorical
43353-050-504335300505050 in 1 BOTTLE, PLASTICHistorical
43353-050-534335300505360 in 1 BOTTLE, PLASTICHistorical
43353-050-554335300505575 in 1 BOTTLE, PLASTICHistorical
43353-050-574335300505780 in 1 BOTTLE, PLASTICHistorical
43353-050-604335300506090 in 1 BOTTLE, PLASTICHistorical
43353-050-614335300506170 in 1 BOTTLE, PLASTICHistorical
43353-050-6543353005065100 in 1 BOTTLE, PLASTICHistorical
43353-050-684335300506826 in 1 BOTTLE, PLASTICHistorical
43353-050-7043353005070120 in 1 BOTTLE, PLASTICHistorical
43353-050-784335300507834 in 1 BOTTLE, PLASTICHistorical