Warfarin Sodium

Product NDC: 57237-122
Requested package NDC: 57237-122-01
11-digit product format: 572370122
Labeler code: 57237
Product ID: 57237-122_bab28da8-ce52-4caf-a5ef-8fa777aca739
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: warfarin sodium
Dosage form: TABLET
Route: ORAL
Labeler: Rising Health, LLC
Application: ANDA090935
Marketing category: ANDA
Marketing start: 2011-11-11
Marketing end: 0000-00-00
Substance: WARFARIN SODIUM
Active strength: 3 mg/1
Pharmacologic classes: Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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	57237-122	57237-122-01	D	Discontinued by firm		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A090935-001	WARFARIN SODIUM	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	2011-05-25
A090935-002	WARFARIN SODIUM	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	2011-05-25
A090935-003	WARFARIN SODIUM	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	2011-05-25
A090935-004	WARFARIN SODIUM	WARFARIN SODIUM	3MG	TABLET / ORAL	AB	2011-05-25
A090935-005	WARFARIN SODIUM	WARFARIN SODIUM	4MG	TABLET / ORAL	AB	2011-05-25
A090935-006	WARFARIN SODIUM	WARFARIN SODIUM	5MG	TABLET / ORAL	AB	2011-05-25
A090935-007	WARFARIN SODIUM	WARFARIN SODIUM	6MG	TABLET / ORAL	AB	2011-05-25
A090935-008	WARFARIN SODIUM	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB	2011-05-25
A090935-009	WARFARIN SODIUM	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	2011-05-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090935-001	AB
A090935-002	AB
A090935-003	AB
A090935-004	AB
A090935-005	AB
A090935-006	AB
A090935-007	AB
A090935-008	AB
A090935-009	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.

Product history page 1 of 10 · 378 observed 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
2026-08-18 06:07:40	2026-07	A090935-001	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	2011-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090935-002	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	2011-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090935-003	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	2011-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090935-004	WARFARIN SODIUM	3MG	TABLET / ORAL	AB	2011-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090935-005	WARFARIN SODIUM	4MG	TABLET / ORAL	AB	2011-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090935-006	WARFARIN SODIUM	5MG	TABLET / ORAL	AB	2011-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090935-007	WARFARIN SODIUM	6MG	TABLET / ORAL	AB	2011-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090935-008	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB	2011-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090935-009	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	2011-05-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090935-001	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	2011-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090935-002	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	2011-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090935-003	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	2011-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090935-004	WARFARIN SODIUM	3MG	TABLET / ORAL	AB	2011-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090935-005	WARFARIN SODIUM	4MG	TABLET / ORAL	AB	2011-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090935-006	WARFARIN SODIUM	5MG	TABLET / ORAL	AB	2011-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090935-007	WARFARIN SODIUM	6MG	TABLET / ORAL	AB	2011-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090935-008	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB	2011-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090935-009	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	2011-05-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090935-001	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	2011-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090935-002	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	2011-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090935-003	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	2011-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090935-004	WARFARIN SODIUM	3MG	TABLET / ORAL	AB	2011-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090935-005	WARFARIN SODIUM	4MG	TABLET / ORAL	AB	2011-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090935-006	WARFARIN SODIUM	5MG	TABLET / ORAL	AB	2011-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090935-007	WARFARIN SODIUM	6MG	TABLET / ORAL	AB	2011-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090935-008	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB	2011-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090935-009	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	2011-05-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090935-001	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	2011-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090935-002	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	2011-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090935-003	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	2011-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090935-004	WARFARIN SODIUM	3MG	TABLET / ORAL	AB	2011-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090935-005	WARFARIN SODIUM	4MG	TABLET / ORAL	AB	2011-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090935-006	WARFARIN SODIUM	5MG	TABLET / ORAL	AB	2011-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090935-007	WARFARIN SODIUM	6MG	TABLET / ORAL	AB	2011-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090935-008	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB	2011-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090935-009	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	2011-05-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090935-001	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	2011-05-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090935-002	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	2011-05-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090935-003	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	2011-05-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090935-004	WARFARIN SODIUM	3MG	TABLET / ORAL	AB	2011-05-25	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 10 · 378 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090935-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090935-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090935-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090935-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090935-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090935-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090935-007	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090935-008	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090935-009	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090935-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090935-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090935-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090935-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090935-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090935-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090935-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090935-008	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090935-009	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090935-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090935-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090935-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090935-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090935-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090935-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090935-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090935-008	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090935-009	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090935-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090935-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090935-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090935-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090935-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090935-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090935-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090935-008	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090935-009	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090935-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090935-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090935-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090935-004	AB	1	`fd3edfee7708…`

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57237-122-01	EA - Each	57237-122	ed53c6a1-d87d-4432-a002-7526bea1b97e	1	2015-05-05
57237-122-99	EA - Each	57237-122	288d97a5-232c-45cf-8be8-30d6e5a5e267	1	2015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
WARFARIN SODIUM	ACTIVE INGREDIENT	6153CWM0CL	WARFARIN SODIUM TABLET [CITRON PHARMA LLC]	2
WARFARIN	ACTIVE MOIETY	5Q7ZVV76EI	WARFARIN SODIUM TABLET [CITRON PHARMA LLC]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	WARFARIN SODIUM TABLET [CITRON PHARMA LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	WARFARIN SODIUM TABLET [CITRON PHARMA LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	WARFARIN SODIUM TABLET [CITRON PHARMA LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	WARFARIN SODIUM TABLET [CITRON PHARMA LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57237-122	WARFARIN SODIUM TABLET [RISING HEALTH, LLC]	7	Legacy NDC	20180926_8373fced-93fe-44c6-93d9-8f21c6599f65.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Warfarin Sodium	WARFARIN	Aphena Pharma Solutions - Tennessee, LLC	4f276251-49b7-438f-9c47-f1cdfc47e519	2026-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090935 application number: ANDA090935
Warfarin Sodium	WARFARIN	Golden State Medical Supply, Inc.	a2f6c9f7-87dc-7428-e053-2995a90a1de6	2025-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090935 application number: ANDA090935
WARFARIN SODIUM	WARFARIN SODIUM	DIRECT RX	c186d1ff-64dd-bfcb-e053-2a95a90af800	2025-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090935 application number: ANDA090935
Warfarin Sodium	WARFARIN	Aphena Pharma Solutions - Tennessee, LLC	52b3c2f6-b5ca-44ae-bdcc-552d5191034f	2021-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090935 application number: ANDA090935
Warfarin Sodium	WARFARIN	Aphena Pharma Solutions - Tennessee, LLC	a98916a5-cdb2-4251-bdea-0245c763b2f1	2020-12-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090935 application number: ANDA090935
Warfarin Sodium	WARFARIN	Exelan Pharmaceuticals Inc.	c0cc4511-e656-4b6d-96cd-e02e76173b9d	2020-09-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090935 application number: ANDA090935
Warfarin Sodium	WARFARIN	Aphena Pharma Solutions - Tennessee, LLC	91f24482-d4cb-4a09-a97e-64f6e49071ee	2020-08-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090935 application number: ANDA090935

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
855318	warfarin sodium 3 MG Oral Tablet	PSN	1d47272d-979e-46fe-814f-7b835a0f23d4	101
855318	warfarin sodium 3 MG Oral Tablet	SCD	1d47272d-979e-46fe-814f-7b835a0f23d4	101

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57237-122-01	57237012201	100 TABLET in 1 BOTTLE (57237-122-01)	100 tablet	2011-11-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Warfarin Sodium	Bryant Ranch Prepack	2024-05-24	HUMAN PRESCRIPTION DRUG LABEL	102
Warfarin Sodium	Bryant Ranch Prepack	2024-01-26	HUMAN PRESCRIPTION DRUG LABEL	100
Warfarin Sodium	A-S Medication Solutions	2023-04-27	Human Prescription Drug Label	18
Warfarin Sodium	Proficient Rx LP	2022-10-01	HUMAN PRESCRIPTION DRUG LABEL	1
Warfarin Sodium	NuCare Pharmaceuticals,Inc.	2022-01-17	HUMAN PRESCRIPTION DRUG LABEL	4
Warfarin Sodium	Bryant Ranch Prepack	2021-12-16	HUMAN PRESCRIPTION DRUG LABEL	101
Warfarin Sodium	NuCare Pharmaceuticals,Inc.	2021-02-19	HUMAN PRESCRIPTION DRUG LABEL	2
Warfarin Sodium	Rising Health, LLC \| InvaGen Pharmaceuticals, Inc	2018-07-26	Human Prescription Drug Label	7