Warfarin Sodium

Product NDC: 50436-9946
11-digit product format: 504369946
Labeler code: 50436
Product ID: 50436-9946_fde8e330-e3ac-4053-949d-652edd69c6b1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Warfarin Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Unit Dose Services
Application: ANDA040663
Marketing category: ANDA
Marketing start: 2006-06-19
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: No
Listing certified through: 2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50436-9946		I	Inactivated by FDA		2026-07-31
excluded package	package	50436-9946	50436-9946-2	I	Inactivated by FDA		2026-07-31

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A040663-001	WARFARIN SODIUM	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	2006-05-30
A040663-002	WARFARIN SODIUM	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	2006-05-30
A040663-003	WARFARIN SODIUM	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	2006-05-30
A040663-004	WARFARIN SODIUM	WARFARIN SODIUM	3MG	TABLET / ORAL	AB	2006-05-30
A040663-005	WARFARIN SODIUM	WARFARIN SODIUM	4MG	TABLET / ORAL	AB	2006-05-30
A040663-006	WARFARIN SODIUM	WARFARIN SODIUM	5MG	TABLET / ORAL	AB	2006-05-30
A040663-007	WARFARIN SODIUM	WARFARIN SODIUM	6MG	TABLET / ORAL	AB	2006-05-30
A040663-008	WARFARIN SODIUM	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB	2006-05-30
A040663-009	WARFARIN SODIUM	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	2006-05-30

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A040663-001	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	2006-05-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040663-002	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	2006-05-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040663-003	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	2006-05-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040663-004	WARFARIN SODIUM	3MG	TABLET / ORAL	AB	2006-05-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040663-005	WARFARIN SODIUM	4MG	TABLET / ORAL	AB	2006-05-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040663-006	WARFARIN SODIUM	5MG	TABLET / ORAL	AB	2006-05-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040663-007	WARFARIN SODIUM	6MG	TABLET / ORAL	AB	2006-05-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040663-008	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB	2006-05-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040663-009	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	2006-05-30	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A040663-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040663-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040663-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040663-004	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040663-005	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040663-006	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040663-007	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040663-008	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040663-009	AB	1	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
abcfe2f4-1eca-fdc3-341b-b8134a1aec1f	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50436-9946-2	2020-01-31	C162847	48780-1	9d75b9d0-2b6c-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use warfarin sodium safely and effectively. See full prescribing information for warfarin sodium. Initial U.S. Approval: 1954

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50436-9946-2	Warfarin Sodium	30 in 1 BOTTLE	TABLET	30		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
WARFARIN SODIUM	ACTIVE INGREDIENT	6153CWM0CL	WARFARIN SODIUM TABLET [UNIT DOSE SERVICES]	2
WARFARIN	ACTIVE MOIETY	5Q7ZVV76EI	WARFARIN SODIUM TABLET [UNIT DOSE SERVICES]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	WARFARIN SODIUM TABLET [UNIT DOSE SERVICES]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	WARFARIN SODIUM TABLET [UNIT DOSE SERVICES]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	WARFARIN SODIUM TABLET [UNIT DOSE SERVICES]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	WARFARIN SODIUM TABLET [UNIT DOSE SERVICES]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	WARFARIN SODIUM TABLET [UNIT DOSE SERVICES]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	WARFARIN SODIUM TABLET [UNIT DOSE SERVICES]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-9946	WARFARIN SODIUM TABLET [UNIT DOSE SERVICES]	2	Legacy NDC, 1 package rows	20131218_03845452-4ec4-4593-abdf-5a6cc8d241a9.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6153CWM0CL	WARFARIN SODIUM	129-06-6	WARFARIN SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
855302	warfarin sodium 2 MG Oral Tablet	PSN	03845452-4ec4-4593-abdf-5a6cc8d241a9	2
855302	warfarin sodium 2 MG Oral Tablet	SCD	03845452-4ec4-4593-abdf-5a6cc8d241a9	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
50436-9946-2	50436994602	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Warfarin Sodium - Unit Dose Services	Unit Dose Services	2012-06-25	HUMAN PRESCRIPTION DRUG LABEL	2