Warfarin Sodium

Product NDC: 53217-001
11-digit product format: 532170001
Labeler code: 53217
Product ID: 53217-001_69b4a3d6-0e03-4e4b-9377-0926bae0faef
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Warfarin Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA040663
Marketing category: ANDA
Marketing start: 2006-06-19
Marketing end: 0000-00-00
Substance: WARFARIN SODIUM
Active strength: 10 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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53217-001		I	Inactivated by FDA	2026-07-31
excluded package	package	53217-001	53217-001-07	I	Inactivated by FDA	2026-07-31
excluded package	package	53217-001	53217-001-14	I	Inactivated by FDA	2026-07-31
excluded package	package	53217-001	53217-001-30	I	Inactivated by FDA	2026-07-31
excluded package	package	53217-001	53217-001-60	I	Inactivated by FDA	2026-07-31
excluded package	package	53217-001	53217-001-90	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
53217-001-07	2020-01-31	C162847	48780-1	9d75b9d0-a2ca-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
53217-001-14	2020-01-31	C162847	48780-1	9d75b9d0-a2ca-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
53217-001-30	2020-01-31	C162847	48780-1	9d75b9d0-a2ca-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
53217-001-60	2020-01-31	C162847	48780-1	9d75b9d0-a2ca-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
53217-001-90	2020-01-31	C162847	48780-1	9d75b9d0-a2ca-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	SPL version
53217-001-07	Warfarin Sodium	7 in 1 BOTTLE, PLASTIC	TABLET	7	1
53217-001-14	Warfarin Sodium	14 in 1 BOTTLE, PLASTIC	TABLET	14	1
53217-001-30	Warfarin Sodium	30 in 1 BOTTLE, PLASTIC	TABLET	30	1
53217-001-60	Warfarin Sodium	60 in 1 BOTTLE, PLASTIC	TABLET	60	1
53217-001-90	Warfarin Sodium	90 in 1 BOTTLE, PLASTIC	TABLET	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53217-001-30	EA - Each	53217-001	a8c498d6-fc4e-48f1-9be9-f81dbe09dac3	1	2015-10-02
53217-001-60	EA - Each	53217-001	44f073ea-f438-41cb-bd44-a88237e623c7	1	2015-10-02
53217-001-90	EA - Each	53217-001	0f4b10aa-a411-47e9-9506-9d7764c91733	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
WARFARIN SODIUM	ACTIVE INGREDIENT	6153CWM0CL	WARFARIN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]	1
WARFARIN	ACTIVE MOIETY	5Q7ZVV76EI	WARFARIN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	WARFARIN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	WARFARIN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	WARFARIN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	WARFARIN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53217-001	WARFARIN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 5 package rows	20140214_25146c2b-91dc-452a-8628-23eacd5a9f79.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
855296	warfarin sodium 10 MG Oral Tablet	PSN	25146c2b-91dc-452a-8628-23eacd5a9f79	1
855296	warfarin sodium 10 MG Oral Tablet	SCD	25146c2b-91dc-452a-8628-23eacd5a9f79	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53217-001-07	53217000107	7 in 1 BOTTLE, PLASTIC	Historical
53217-001-14	53217000114	14 in 1 BOTTLE, PLASTIC	Historical
53217-001-30	53217000130	30 in 1 BOTTLE, PLASTIC	Historical
53217-001-60	53217000160	60 in 1 BOTTLE, PLASTIC	Historical
53217-001-90	53217000190	90 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Warfarin Sodium - Aidarex Pharmaceuticals LLC	Aidarex Pharmaceuticals LLC	2013-10-04	HUMAN PRESCRIPTION DRUG LABEL	1