FDA.reportPublic FDA data

Warfarin Sodium

Product NDC
21695-673
11-digit product format
216950673
Labeler code
21695
Product ID
21695-673_e463ea06-12a7-463c-90eb-082d0035b55f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Warfarin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA040663
Marketing category
ANDA
Marketing start
2006-05-30
Marketing end
0000-00-00
Substance
WARFARIN SODIUM
Active strength
2 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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21695-673IInactivated by FDA2026-07-31
excluded packagepackage21695-67321695-673-30IInactivated by FDA2026-07-31
excluded packagepackage21695-67321695-673-60IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 9 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040663-001WARFARIN SODIUMWARFARIN SODIUM1MGTABLET / ORALAB2006-05-30
A040663-002WARFARIN SODIUMWARFARIN SODIUM2MGTABLET / ORALAB2006-05-30
A040663-003WARFARIN SODIUMWARFARIN SODIUM2.5MGTABLET / ORALAB2006-05-30
A040663-004WARFARIN SODIUMWARFARIN SODIUM3MGTABLET / ORALAB2006-05-30
A040663-005WARFARIN SODIUMWARFARIN SODIUM4MGTABLET / ORALAB2006-05-30
A040663-006WARFARIN SODIUMWARFARIN SODIUM5MGTABLET / ORALAB2006-05-30
A040663-007WARFARIN SODIUMWARFARIN SODIUM6MGTABLET / ORALAB2006-05-30
A040663-008WARFARIN SODIUMWARFARIN SODIUM7.5MGTABLET / ORALAB2006-05-30
A040663-009WARFARIN SODIUMWARFARIN SODIUM10MGTABLET / ORALAB2006-05-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 9 matching rows.

Application-product, TE code table
Application-productTE code
A040663-001AB
A040663-002AB
A040663-003AB
A040663-004AB
A040663-005AB
A040663-006AB
A040663-007AB
A040663-008AB
A040663-009AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A040663-001WARFARIN SODIUM1MGTABLET / ORALAB2006-05-30a50c72e98297…
2026-08-01 22:54:322026-06A040663-002WARFARIN SODIUM2MGTABLET / ORALAB2006-05-30a50c72e98297…
2026-08-01 22:54:322026-06A040663-003WARFARIN SODIUM2.5MGTABLET / ORALAB2006-05-30a50c72e98297…
2026-08-01 22:54:322026-06A040663-004WARFARIN SODIUM3MGTABLET / ORALAB2006-05-30a50c72e98297…
2026-08-01 22:54:322026-06A040663-005WARFARIN SODIUM4MGTABLET / ORALAB2006-05-30a50c72e98297…
2026-08-01 22:54:322026-06A040663-006WARFARIN SODIUM5MGTABLET / ORALAB2006-05-30a50c72e98297…
2026-08-01 22:54:322026-06A040663-007WARFARIN SODIUM6MGTABLET / ORALAB2006-05-30a50c72e98297…
2026-08-01 22:54:322026-06A040663-008WARFARIN SODIUM7.5MGTABLET / ORALAB2006-05-30a50c72e98297…
2026-08-01 22:54:322026-06A040663-009WARFARIN SODIUM10MGTABLET / ORALAB2006-05-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A040663-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A040663-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A040663-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A040663-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A040663-005AB1a50c72e98297…
2026-08-01 22:54:322026-06A040663-006AB1a50c72e98297…
2026-08-01 22:54:322026-06A040663-007AB1a50c72e98297…
2026-08-01 22:54:322026-06A040663-008AB1a50c72e98297…
2026-08-01 22:54:322026-06A040663-009AB1a50c72e98297…

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
21695-673-302019-09-24C16284748780-1934fe258-4cf5-48b1-e053-8cdaa90a720aWarfarin Sodium Tablets, USP
21695-673-602019-09-24C16284748780-1934fe258-4cf5-48b1-e053-8cdaa90a720aWarfarin Sodium Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-673-30Warfarin Sodium30 in 1 BOTTLETABLET302
21695-673-60Warfarin Sodium60 in 1 BOTTLETABLET602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-673-30EA - Each21695-673c1d0941c-ee2c-43e4-871a-2233947cd4fc12012-07-24
21695-673-60EA - Each21695-6738c3546c7-1974-484b-9c2e-34cb2169fec112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
WARFARIN SODIUMACTIVE INGREDIENT6153CWM0CLWARFARIN SODIUM TABLET [REBEL DISTRIBUTORS CORP]2
WARFARINACTIVE MOIETY5Q7ZVV76EIWARFARIN SODIUM TABLET [REBEL DISTRIBUTORS CORP]2
D&C RED NO. 6INACTIVE INGREDIENT481744AI4OWARFARIN SODIUM TABLET [REBEL DISTRIBUTORS CORP]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GWARFARIN SODIUM TABLET [REBEL DISTRIBUTORS CORP]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDWARFARIN SODIUM TABLET [REBEL DISTRIBUTORS CORP]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKWARFARIN SODIUM TABLET [REBEL DISTRIBUTORS CORP]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAWARFARIN SODIUM TABLET [REBEL DISTRIBUTORS CORP]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8WARFARIN SODIUM TABLET [REBEL DISTRIBUTORS CORP]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PWARFARIN SODIUM TABLET [REBEL DISTRIBUTORS CORP]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XWARFARIN SODIUM TABLET [REBEL DISTRIBUTORS CORP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30WARFARIN SODIUM TABLET [REBEL DISTRIBUTORS CORP]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJWARFARIN SODIUM TABLET [REBEL DISTRIBUTORS CORP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-673WARFARIN SODIUM TABLET [REBEL DISTRIBUTORS CORP]2Legacy NDC, 2 package rows20110517_36a919ce-7a21-40c0-9af5-2299bf2b1f97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855288warfarin sodium 1 MG Oral TabletPSN36a919ce-7a21-40c0-9af5-2299bf2b1f972
855296warfarin sodium 10 MG Oral TabletPSN36a919ce-7a21-40c0-9af5-2299bf2b1f972
855302warfarin sodium 2 MG Oral TabletPSN36a919ce-7a21-40c0-9af5-2299bf2b1f972
855312warfarin sodium 2.5 MG Oral TabletPSN36a919ce-7a21-40c0-9af5-2299bf2b1f972
855318warfarin sodium 3 MG Oral TabletPSN36a919ce-7a21-40c0-9af5-2299bf2b1f972
855332warfarin sodium 5 MG Oral TabletPSN36a919ce-7a21-40c0-9af5-2299bf2b1f972
855288warfarin sodium 1 MG Oral TabletSCD36a919ce-7a21-40c0-9af5-2299bf2b1f972
855296warfarin sodium 10 MG Oral TabletSCD36a919ce-7a21-40c0-9af5-2299bf2b1f972
855302warfarin sodium 2 MG Oral TabletSCD36a919ce-7a21-40c0-9af5-2299bf2b1f972
855312warfarin sodium 2.5 MG Oral TabletSCD36a919ce-7a21-40c0-9af5-2299bf2b1f972
855318warfarin sodium 3 MG Oral TabletSCD36a919ce-7a21-40c0-9af5-2299bf2b1f972
855332warfarin sodium 5 MG Oral TabletSCD36a919ce-7a21-40c0-9af5-2299bf2b1f972

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-673-302169506733030 in 1 BOTTLEHistorical
21695-673-602169506736060 in 1 BOTTLEHistorical