Warfarin Sodium

Product NDC: 68788-7357
Requested package NDC: 68788-7357-9
11-digit product format: 687887357
Labeler code: 68788
Product ID: 68788-7357_119944bd-6e8b-4f98-bb7d-9aba0b9cd92e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: warfarin sodium
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA090935
Marketing category: ANDA
Marketing start: 2011-11-11
Substance: WARFARIN SODIUM
Active strength: 2.5 mg/1
Pharmacologic classes: Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	68788-7357	68788-7357-9	E	Excluded after deficient or non-compliant submission was not corrected		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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68788-7357-1	Warfarin Sodium	100 in 1 BOTTLE	TABLET	100	7
68788-7357-3	Warfarin Sodium	30 in 1 BOTTLE	TABLET	30	7
68788-7357-6	Warfarin Sodium	60 in 1 BOTTLE	TABLET	60	7
68788-7357-9	Warfarin Sodium	90 in 1 BOTTLE	TABLET	90	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-7357	WARFARIN SODIUM TABLET [PREFERRED PHARMACEUTICALS, INC.]	6	Current NDC, Legacy NDC, 4 package rows	20240906_b0e742c8-0768-4704-8871-708c27daa65b.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
855312	warfarin sodium 2.5 MG Oral Tablet	PSN	b0e742c8-0768-4704-8871-708c27daa65b	7
855312	warfarin sodium 2.5 MG Oral Tablet	SCD	b0e742c8-0768-4704-8871-708c27daa65b	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7357-9	68788735709	90 TABLET in 1 BOTTLE (68788-7357-9)	90 tablet	2019-09-27	0000-00-00	No	No	Current