Warfarin Sodium

Product NDC: 65841-055
Requested package NDC: 65841-055-01
11-digit product format: 658410055
Labeler code: 65841
Product ID: 65841-055_d574b623-3aee-4c1f-b85b-e9e51d388286
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Warfarin Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Zydus Lifesciences Limited
Application: ANDA040663
Marketing category: ANDA
Marketing start: 2006-06-19
Marketing end: 0000-00-00
Substance: WARFARIN SODIUM
Active strength: 4 mg/1
Pharmacologic classes: Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	65841-055	65841-055-01	D	Discontinued by firm		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 Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
WARFARIN SODIUM	ACTIVE INGREDIENT	6153CWM0CL	WARFARIN SODIUM TABLET [CADILA HEALTHCARE LIMITED]	3
WARFARIN	ACTIVE MOIETY	5Q7ZVV76EI	WARFARIN SODIUM TABLET [CADILA HEALTHCARE LIMITED]	3
D&C RED NO. 6	INACTIVE INGREDIENT	481744AI4O	WARFARIN SODIUM TABLET [CADILA HEALTHCARE LIMITED]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	WARFARIN SODIUM TABLET [CADILA HEALTHCARE LIMITED]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	WARFARIN SODIUM TABLET [CADILA HEALTHCARE LIMITED]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	WARFARIN SODIUM TABLET [CADILA HEALTHCARE LIMITED]	3
FD&C RED NO. 4	INACTIVE INGREDIENT	X3W0AM1JLX	WARFARIN SODIUM TABLET [CADILA HEALTHCARE LIMITED]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	WARFARIN SODIUM TABLET [CADILA HEALTHCARE LIMITED]	3
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	WARFARIN SODIUM TABLET [CADILA HEALTHCARE LIMITED]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	WARFARIN SODIUM TABLET [CADILA HEALTHCARE LIMITED]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	WARFARIN SODIUM TABLET [CADILA HEALTHCARE LIMITED]	3
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	WARFARIN SODIUM TABLET [CADILA HEALTHCARE LIMITED]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65841-055	WARFARIN SODIUM TABLET [ZYDUS LIFESCIENCES LIMITED]	8	Legacy NDC	20231005_3fb2aa58-3a40-4255-a261-e2db5b9a5dde.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65841-055-01	65841005501	100 TABLET in 1 BOTTLE (65841-055-01)	100 tablet	2006-06-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
WARFARIN SODIUM TABLETS, USP	Zydus Lifesciences Limited	2023-10-03	HUMAN PRESCRIPTION DRUG LABEL	8