Warfarin Sodium

Product NDC: 70518-2394
11-digit product format: 705182394
Labeler code: 70518
Product ID: 70518-2394_55779286-0836-a465-e063-6394a90afc5b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Warfarin
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA202202
Marketing category: ANDA
Marketing start: 2019-10-28
Substance: WARFARIN SODIUM
Active strength: 6 mg/1
Pharmacologic classes: Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
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	70518-2394	70518-2394-0	D	Discontinued by firm		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 · 27 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-2394-0	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-2394-0	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-2394-0	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-2394-0	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-2394-0	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-2394-0	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-2394-0	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-2394-0	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-2394-0	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-2394-0	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-2394-0	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-2394-0	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`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	Approval date
A202202-001	WARFARIN SODIUM	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	2013-03-04
A202202-002	WARFARIN SODIUM	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	2013-03-04
A202202-003	WARFARIN SODIUM	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	2013-03-04
A202202-004	WARFARIN SODIUM	WARFARIN SODIUM	3MG	TABLET / ORAL	AB	2013-03-04
A202202-005	WARFARIN SODIUM	WARFARIN SODIUM	4MG	TABLET / ORAL	AB	2013-03-04
A202202-006	WARFARIN SODIUM	WARFARIN SODIUM	5MG	TABLET / ORAL	AB	2013-03-04
A202202-007	WARFARIN SODIUM	WARFARIN SODIUM	6MG	TABLET / ORAL	AB	2013-03-04
A202202-008	WARFARIN SODIUM	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB	2013-03-04
A202202-009	WARFARIN SODIUM	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	2013-03-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202202-001	AB
A202202-002	AB
A202202-003	AB
A202202-004	AB
A202202-005	AB
A202202-006	AB
A202202-007	AB
A202202-008	AB
A202202-009	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A202202-001	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	2013-03-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202202-002	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	2013-03-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202202-003	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	2013-03-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202202-004	WARFARIN SODIUM	3MG	TABLET / ORAL	AB	2013-03-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202202-005	WARFARIN SODIUM	4MG	TABLET / ORAL	AB	2013-03-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202202-006	WARFARIN SODIUM	5MG	TABLET / ORAL	AB	2013-03-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202202-007	WARFARIN SODIUM	6MG	TABLET / ORAL	AB	2013-03-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202202-008	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB	2013-03-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202202-009	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	2013-03-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202202-001	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	2013-03-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202202-002	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	2013-03-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202202-003	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	2013-03-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202202-004	WARFARIN SODIUM	3MG	TABLET / ORAL	AB	2013-03-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202202-005	WARFARIN SODIUM	4MG	TABLET / ORAL	AB	2013-03-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202202-006	WARFARIN SODIUM	5MG	TABLET / ORAL	AB	2013-03-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202202-007	WARFARIN SODIUM	6MG	TABLET / ORAL	AB	2013-03-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202202-008	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB	2013-03-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202202-009	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	2013-03-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202202-001	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	2013-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202202-002	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	2013-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202202-003	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	2013-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202202-004	WARFARIN SODIUM	3MG	TABLET / ORAL	AB	2013-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202202-005	WARFARIN SODIUM	4MG	TABLET / ORAL	AB	2013-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202202-006	WARFARIN SODIUM	5MG	TABLET / ORAL	AB	2013-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202202-007	WARFARIN SODIUM	6MG	TABLET / ORAL	AB	2013-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202202-008	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB	2013-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202202-009	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	2013-03-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202202-001	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	2013-03-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202202-002	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	2013-03-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202202-003	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	2013-03-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202202-004	WARFARIN SODIUM	3MG	TABLET / ORAL	AB	2013-03-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202202-005	WARFARIN SODIUM	4MG	TABLET / ORAL	AB	2013-03-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202202-006	WARFARIN SODIUM	5MG	TABLET / ORAL	AB	2013-03-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202202-007	WARFARIN SODIUM	6MG	TABLET / ORAL	AB	2013-03-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202202-008	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB	2013-03-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202202-009	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	2013-03-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202202-001	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	2013-03-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202202-002	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	2013-03-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202202-003	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	2013-03-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202202-004	WARFARIN SODIUM	3MG	TABLET / ORAL	AB	2013-03-04	`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	A202202-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202202-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202202-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202202-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202202-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202202-006	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202202-007	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202202-008	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202202-009	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202202-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202202-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202202-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202202-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202202-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202202-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202202-007	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202202-008	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202202-009	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202202-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202202-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202202-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202202-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202202-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202202-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202202-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202202-008	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202202-009	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202202-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202202-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202202-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202202-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202202-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202202-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202202-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202202-008	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202202-009	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202202-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202202-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202202-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202202-004	AB	1	`6a471c1ec25d…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Warfarin Sodium
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
WARFARIN SODIUM	6 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6153CWM0CL	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
855338	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d7fb4290-ed37-4ed3-ae51-c400191961dc	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-2394-0	2024-01-30	C162847	48780-1	1030e365-4cb7-111a-e063-dadaa90a10e2	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 (crystalline), for oral use Initial U.S. Approval: 1954

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-2394	WARFARIN SODIUM (WARFARIN) TABLET [REMEDYREPACK INC.]	4	Current NDC, Legacy NDC	20220402_d7fb4290-ed37-4ed3-ae51-c400191961dc.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 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Warfarin Sodium	WARFARIN	Coupler LLC	5a5b5e3a-6556-a542-e063-6294a90a6d3f	2026-08-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202202 application number: ANDA202202
Warfarin Sodium	WARFARIN	Coupler LLC	598e5e2e-9264-8371-e063-6394a90aaf18	2026-08-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202202 application number: ANDA202202
Warfarin Sodium	WARFARIN	REMEDYREPACK INC.	d7fb4290-ed37-4ed3-ae51-c400191961dc	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202202 application number: ANDA202202 ndc (product): 70518-2394
Warfarin Sodium	WARFARIN	REMEDYREPACK INC.	51e98fb6-ba76-497e-95d8-fe895ef0b7ed	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202202 application number: ANDA202202
Warfarin Sodium	WARFARIN	REMEDYREPACK INC.	a4cf3107-5646-4b91-8aae-94548e4409ef	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202202 application number: ANDA202202
Warfarin Sodium	WARFARIN	REMEDYREPACK INC.	2fb8b8d5-f643-4069-8e47-5eae31a8fbc8	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202202 application number: ANDA202202
Warfarin Sodium	WARFARIN	REMEDYREPACK INC.	884cdbf6-0a52-4126-8e14-b0d7c9367e33	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202202 application number: ANDA202202
Warfarin Sodium	WARFARIN	REMEDYREPACK INC.	8eddba53-19c4-411b-b0d4-cb2f948ba125	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202202 application number: ANDA202202
Warfarin Sodium	WARFARIN	REMEDYREPACK INC.	2cbcc99d-9107-4d39-a1e9-e19305de8b5d	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202202 application number: ANDA202202
Warfarin Sodium	WARFARIN	REMEDYREPACK INC.	8ee94789-72d2-4c42-9dbd-0501e9767d97	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202202 application number: ANDA202202
Warfarin Sodium	WARFARIN	REMEDYREPACK INC.	545ec40d-2db1-4581-b3ec-ce195e5f5400	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202202 application number: ANDA202202
Warfarin Sodium	WARFARIN	Amneal Pharmaceuticals LLC	558b7a0d-5490-4c1b-802e-3ab3f1efe760	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202202 application number: ANDA202202
Warfarin Sodium	WARFARIN	Coupler LLC	52bacf1e-9ba8-7eca-e063-6394a90ab60b	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202202 application number: ANDA202202
Warfarin Sodium	WARFARIN	Coupler LLC	5256c518-31bf-f73b-e063-6394a90a71da	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202202 application number: ANDA202202
Warfarin Sodium	WARFARIN	Coupler LLC	2f2119e8-f583-ba16-e063-6394a90a13a2	2025-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202202 application number: ANDA202202
Warfarin Sodium	WARFARIN	Coupler LLC	2d58d204-4976-95cf-e063-6394a90a34b7	2025-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202202 application number: ANDA202202
Warfarin Sodium	WARFARIN	Bryant Ranch Prepack	8c876dd3-d659-479e-994c-39454c7028cc	2025-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202202 application number: ANDA202202
WARFARIN SODIUM	WARFARIN SODIUM	Direct_Rx	efded00a-22b9-1da7-e053-2995a90a58ca	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202202 application number: ANDA202202
Warfarin Sodium	WARFARIN	Preferred Pharmaceuticals Inc.	ac117f50-8e67-4203-8d97-e53dd0687c20	2025-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202202 application number: ANDA202202
Warfarin Sodium	WARFARIN	Bryant Ranch Prepack	7fdfd870-e72d-4d88-b6d9-1d711b66d09f	2024-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202202 application number: ANDA202202

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6153CWM0CL	WARFARIN SODIUM	129-06-6	WARFARIN SODIUM
5Q7ZVV76EI	WARFARIN	81-81-2	Warfarin

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2394-0	70518239400	100 POUCH in 1 BOX (70518-2394-0) > 1 TABLET in 1 POUCH (70518-2394-1)	100 pouch	2019-10-28	0000-00-00	No	No	Current
70518-2394-2	70518239402	30 TABLET in 1 BLISTER PACK (70518-2394-2)	30 tablet	2026-06-30		No	No	Current