Warfarin Sodium

Product NDC: 71610-462
11-digit product format: 716100462
Labeler code: 71610
Product ID: 71610-462_7499368e-bc27-4934-833c-66da6ebf845c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Warfarin
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA090935
Marketing category: ANDA
Marketing start: 2011-05-25
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: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Warfarin Sodium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
WARFARIN SODIUM	2 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
855302	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
52b3c2f6-b5ca-44ae-bdcc-552d5191034f	Available on FDA.report

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
71610-462-30	Warfarin Sodium	30 in 1 BOTTLE	TABLET	30	2
71610-462-35	Warfarin Sodium	35 in 1 BOTTLE	TABLET	35	2
71610-462-40	Warfarin Sodium	40 in 1 BOTTLE	TABLET	40	2
71610-462-45	Warfarin Sodium	45 in 1 BOTTLE	TABLET	45	2
71610-462-53	Warfarin Sodium	60 in 1 BOTTLE	TABLET	60	2
71610-462-60	Warfarin Sodium	90 in 1 BOTTLE	TABLET	90	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-462-35	EA - Each	71610-462	e9c94a28-1d23-47d1-a4f9-19e9694865a4	1	2021-03-02
71610-462-40	EA - Each	71610-462	624535a3-fb06-4a47-9bed-29e713d99148	1	2021-03-02
71610-462-45	EA - Each	71610-462	5ea1c0df-f720-4aab-b30b-7aff933b49d2	1	2021-03-02
71610-462-53	EA - Each	71610-462	b796dba5-e932-4870-b6b4-4d9871ae090f	1	2021-03-02
71610-462-60	EA - Each	71610-462	44af2d7e-9575-427d-a617-a819abb8840f	1	2021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-462	WARFARIN SODIUM (WARFARIN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Current NDC, Legacy NDC, 6 package rows	20210129_52b3c2f6-b5ca-44ae-bdcc-552d5191034f.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 ndc (product): 71610-462
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
5Q7ZVV76EI	WARFARIN	81-81-2	Warfarin

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
855302	warfarin sodium 2 MG Oral Tablet	PSN	52b3c2f6-b5ca-44ae-bdcc-552d5191034f	2
855302	warfarin sodium 2 MG Oral Tablet	SCD	52b3c2f6-b5ca-44ae-bdcc-552d5191034f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-462-30	71610046230	30 TABLET in 1 BOTTLE (71610-462-30)	30 tablet	2020-09-09	0000-00-00	No	No	Current
71610-462-35	71610046235	35 TABLET in 1 BOTTLE (71610-462-35)	35 tablet	2020-12-21	0000-00-00	No	No	Current
71610-462-40	71610046240	40 TABLET in 1 BOTTLE (71610-462-40)	40 tablet	2020-12-21	0000-00-00	No	No	Current
71610-462-45	71610046245	45 TABLET in 1 BOTTLE (71610-462-45)	45 tablet	2020-12-21	0000-00-00	No	No	Current
71610-462-53	71610046253	60 TABLET in 1 BOTTLE (71610-462-53)	60 tablet	2020-12-21	0000-00-00	No	No	Current
71610-462-60	71610046260	90 TABLET in 1 BOTTLE (71610-462-60)	90 tablet	2020-12-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Warfarin Sodium	Aphena Pharma Solutions - Tennessee, LLC	2021-01-28	HUMAN PRESCRIPTION DRUG LABEL	2