Warfarin Sodium

Product NDC: 71610-480
Requested package NDC: 71610-480-45
11-digit product format: 716100480
Labeler code: 71610
Product ID: 71610-480_ab113219-990d-4f99-ae1e-64de78d66730
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Warfarin Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA040616
Marketing category: ANDA
Marketing start: 2015-05-05
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: 2021-12-31
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	71610-480	71610-480-45	I	Inactivated by FDA		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	RLD / RS	Approval date
A040616-001	WARFARIN SODIUM	WARFARIN SODIUM	2MG	TABLET / ORAL	AB		2006-07-05
A040616-002	WARFARIN SODIUM	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB		2006-07-05
A040616-003	WARFARIN SODIUM	WARFARIN SODIUM	3MG	TABLET / ORAL	AB		2006-07-05
A040616-004	WARFARIN SODIUM	WARFARIN SODIUM	4MG	TABLET / ORAL	AB		2006-07-05
A040616-005	WARFARIN SODIUM	WARFARIN SODIUM	5MG	TABLET / ORAL	AB		2006-07-05
A040616-006	WARFARIN SODIUM	WARFARIN SODIUM	6MG	TABLET / ORAL	AB		2006-07-05
A040616-007	WARFARIN SODIUM	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB		2006-07-05
A040616-008	WARFARIN SODIUM	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	RS	2006-07-05
A040616-009	WARFARIN SODIUM	WARFARIN SODIUM	1MG	TABLET / ORAL	AB		2006-07-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040616-001	AB
A040616-002	AB
A040616-003	AB
A040616-004	AB
A040616-005	AB
A040616-006	AB
A040616-007	AB
A040616-008	AB
A040616-009	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 · 387 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040616-001	WARFARIN SODIUM	2MG	TABLET / ORAL	AB		2006-07-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040616-002	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB		2006-07-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040616-003	WARFARIN SODIUM	3MG	TABLET / ORAL	AB		2006-07-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040616-004	WARFARIN SODIUM	4MG	TABLET / ORAL	AB		2006-07-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040616-005	WARFARIN SODIUM	5MG	TABLET / ORAL	AB		2006-07-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040616-006	WARFARIN SODIUM	6MG	TABLET / ORAL	AB		2006-07-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040616-007	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB		2006-07-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040616-008	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	RS	2006-07-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040616-009	WARFARIN SODIUM	1MG	TABLET / ORAL	AB		2006-07-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040616-001	WARFARIN SODIUM	2MG	TABLET / ORAL	AB		2006-07-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040616-002	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB		2006-07-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040616-003	WARFARIN SODIUM	3MG	TABLET / ORAL	AB		2006-07-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040616-004	WARFARIN SODIUM	4MG	TABLET / ORAL	AB		2006-07-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040616-005	WARFARIN SODIUM	5MG	TABLET / ORAL	AB		2006-07-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040616-006	WARFARIN SODIUM	6MG	TABLET / ORAL	AB		2006-07-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040616-007	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB		2006-07-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040616-008	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	RS	2006-07-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040616-009	WARFARIN SODIUM	1MG	TABLET / ORAL	AB		2006-07-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040616-001	WARFARIN SODIUM	2MG	TABLET / ORAL	AB		2006-07-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040616-002	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB		2006-07-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040616-003	WARFARIN SODIUM	3MG	TABLET / ORAL	AB		2006-07-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040616-004	WARFARIN SODIUM	4MG	TABLET / ORAL	AB		2006-07-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040616-005	WARFARIN SODIUM	5MG	TABLET / ORAL	AB		2006-07-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040616-006	WARFARIN SODIUM	6MG	TABLET / ORAL	AB		2006-07-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040616-007	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB		2006-07-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040616-008	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	RS	2006-07-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040616-009	WARFARIN SODIUM	1MG	TABLET / ORAL	AB		2006-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040616-001	WARFARIN SODIUM	2MG	TABLET / ORAL	AB		2006-07-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040616-002	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB		2006-07-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040616-003	WARFARIN SODIUM	3MG	TABLET / ORAL	AB		2006-07-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040616-004	WARFARIN SODIUM	4MG	TABLET / ORAL	AB		2006-07-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040616-005	WARFARIN SODIUM	5MG	TABLET / ORAL	AB		2006-07-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040616-006	WARFARIN SODIUM	6MG	TABLET / ORAL	AB		2006-07-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040616-007	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB		2006-07-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040616-008	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	RS	2006-07-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040616-009	WARFARIN SODIUM	1MG	TABLET / ORAL	AB		2006-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040616-001	WARFARIN SODIUM	2MG	TABLET / ORAL	AB		2006-07-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040616-002	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB		2006-07-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040616-003	WARFARIN SODIUM	3MG	TABLET / ORAL	AB		2006-07-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040616-004	WARFARIN SODIUM	4MG	TABLET / ORAL	AB		2006-07-05	`6a471c1ec25d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 10 · 387 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A040616-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040616-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040616-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040616-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040616-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040616-006	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040616-007	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040616-008	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040616-009	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040616-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040616-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040616-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040616-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040616-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040616-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040616-007	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040616-008	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040616-009	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040616-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040616-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040616-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040616-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040616-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040616-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040616-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040616-008	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040616-009	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040616-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040616-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040616-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040616-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040616-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040616-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040616-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040616-008	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040616-009	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040616-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040616-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040616-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040616-004	AB	1	`6a471c1ec25d…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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, Related label table
NDC	Related label
71610-480-30	These highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets, for oral use Initial U.S. Approval: 1954
71610-480-35	These highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets, for oral use Initial U.S. Approval: 1954
71610-480-40	These highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets, for oral use Initial U.S. Approval: 1954
71610-480-45	These highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets, for oral use Initial U.S. Approval: 1954
71610-480-53	These highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets, for oral use Initial U.S. Approval: 1954
71610-480-60	These highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets, for oral use Initial U.S. Approval: 1954

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71610-480-30	Warfarin Sodium	30 in 1 BOTTLE	TABLET	30	1
71610-480-35	Warfarin Sodium	35 in 1 BOTTLE	TABLET	35	1
71610-480-40	Warfarin Sodium	40 in 1 BOTTLE	TABLET	40	1
71610-480-45	Warfarin Sodium	45 in 1 BOTTLE	TABLET	45	1
71610-480-53	Warfarin Sodium	60 in 1 BOTTLE	TABLET	60	1
71610-480-60	Warfarin Sodium	90 in 1 BOTTLE	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
71610-480-30	EA - Each	71610-480	366dd867-29a4-463d-bc0a-5be7b6885a65	1	2021-02-05
71610-480-35	EA - Each	71610-480	c0493f11-3dfe-4634-a4a1-8c137ab8d83a	1	2021-02-05
71610-480-40	EA - Each	71610-480	7a5ede19-92b0-4685-b1ca-dbc463595fa0	1	2021-02-05
71610-480-45	EA - Each	71610-480	6356c51d-ac5b-456c-943d-db2e77bfda3e	1	2021-02-05
71610-480-53	EA - Each	71610-480	d536efb5-5757-4f83-8ec6-c1b099a17f69	1	2021-02-05
71610-480-60	EA - Each	71610-480	8ba2bba9-c460-4149-9487-8f08d73cf492	1	2021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-480	WARFARIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC, 6 package rows	20201202_2384f45e-ad8e-4367-b99d-a2c670f99d02.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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	724b0061-f42a-4008-a078-09c800ee9785	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	f5fb1a5f-0dda-4f47-8683-ea63ac88a69d	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	1244c338-9140-425a-bf2a-9da6b4ac0287	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	d6083d68-4360-4d47-a1b2-1eb2763024bb	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	4dc2d94e-f856-47da-9d44-24773d97eb87	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	ba65ae56-ca3b-4895-9938-1dde2c3d34bf	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	3f1c3083-91d1-488c-ad07-b198fda21da6	2026-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	748ebea5-c65b-4b5a-b237-f4eb880865fa	2026-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	b1bd0d02-eccb-4449-82b9-9b552835029e	2026-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	Northwind Health Company, LLC	f32d3578-0c90-567c-e053-2a95a90a23b8	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	Northwind Health Company, LLC	f32dd451-3f7a-815b-e053-2995a90a528f	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	Northwind Health Company, LLC	f86fe457-a1b6-e54d-e053-6294a90a9bc7	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	Bryant Ranch Prepack	3aeb6bb1-bc43-4fe7-83f2-36cd0bf46102	2025-08-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	Bryant Ranch Prepack	8eae6b6c-1851-4342-b320-7e1896894658	2025-08-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	Bryant Ranch Prepack	a1860448-d4ef-40f2-b096-056429ca3aea	2025-08-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	Bryant Ranch Prepack	d166f83b-7052-4dc7-b7d4-47faae7dcaed	2025-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	Bryant Ranch Prepack	e7f78a33-71eb-4aac-ba9d-70f75136fab0	2025-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	PD-Rx Pharmaceuticals, Inc.	21255cd5-3c2e-4574-9620-9347d14256b3	2025-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	Bryant Ranch Prepack	4f8afe14-897c-458b-b76f-9bae6fa6110e	2025-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616
Warfarin Sodium	WARFARIN SODIUM	Bryant Ranch Prepack	44077bb7-6007-4c15-bbcd-a7a02ac081ce	2025-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040616 application number: ANDA040616

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	2384f45e-ad8e-4367-b99d-a2c670f99d02	1
855332	warfarin sodium 5 MG Oral Tablet	PSN	2384f45e-ad8e-4367-b99d-a2c670f99d02	1
855302	warfarin sodium 2 MG Oral Tablet	SCD	2384f45e-ad8e-4367-b99d-a2c670f99d02	1
855332	warfarin sodium 5 MG Oral Tablet	SCD	2384f45e-ad8e-4367-b99d-a2c670f99d02	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-480-45	71610048045	45 TABLET in 1 BOTTLE (71610-480-45)	45 tablet	2020-11-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Warfarin Sodium	Aphena Pharma Solutions - Tennessee, LLC	2020-11-30	HUMAN PRESCRIPTION DRUG LABEL	1