Warfarin Sodium

Product NDC: 65162-768
11-digit product format: 651620768
Labeler code: 65162
Product ID: 65162-768_55689f10-365b-449e-b224-52363f835529
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Warfarin
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA202202
Marketing category: ANDA
Marketing start: 2010-08-16
Substance: WARFARIN SODIUM
Active strength: 7.5 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

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
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 · 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	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…`
2025-08-23 18:47 UTC	2025-08	A202202-005	WARFARIN SODIUM	4MG	TABLET / ORAL	AB	2013-03-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202202-006	WARFARIN SODIUM	5MG	TABLET / ORAL	AB	2013-03-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202202-007	WARFARIN SODIUM	6MG	TABLET / ORAL	AB	2013-03-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202202-008	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB	2013-03-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202202-009	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	2013-03-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202202-001	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	2013-03-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202202-002	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	2013-03-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202202-003	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	2013-03-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202202-004	WARFARIN SODIUM	3MG	TABLET / ORAL	AB	2013-03-04	`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	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…`
2025-08-23 18:47 UTC	2025-08	A202202-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202202-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202202-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202202-008	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202202-009	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202202-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202202-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202202-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202202-004	AB	1	`fd3edfee7708…`

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	7.5 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 · 9 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
855288	Internal RxNorm lookup
855296	Internal RxNorm lookup
855302	Internal RxNorm lookup
855312	Internal RxNorm lookup
855318	Internal RxNorm lookup
855324	Internal RxNorm lookup
855332	Internal RxNorm lookup
855338	Internal RxNorm lookup
855344	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
558b7a0d-5490-4c1b-802e-3ab3f1efe760	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
65162-768-10	Warfarin Sodium	100 in 1 BOTTLE	TABLET	100	19
65162-768-11	Warfarin Sodium	1000 in 1 BOTTLE	TABLET	1000	19
65162-768-50	Warfarin Sodium	500 in 1 BOTTLE	TABLET	500	19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65162-768-10	EA - Each	65162-768	877694d2-3e47-46ed-b2d6-422643601fb4	1	2013-06-04
65162-768-11	EA - Each	65162-768	23069fb7-80fb-4206-b375-987bde60cce5	1	2013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
WARFARIN SODIUM	ACTIVE INGREDIENT	6153CWM0CL	WARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS, LLC]	7
WARFARIN	ACTIVE MOIETY	5Q7ZVV76EI	WARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS, LLC]	7
D&C RED NO. 6	INACTIVE INGREDIENT	481744AI4O	WARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS, LLC]	7
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	WARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS, LLC]	7
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	WARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS, LLC]	7
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	WARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS, LLC]	7
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	WARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS, LLC]	7
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	WARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS, LLC]	7
HYDROXYPROPYL CELLULOSE (TYPE E)	INACTIVE INGREDIENT	66O7AQV0RT	WARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS, LLC]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	WARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS, LLC]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	WARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS, LLC]	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	WARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS, LLC]	7
WARFARIN SODIUM	ACTIVE INGREDIENT	6153CWM0CL	WARFARIN SODIUM (WARFARIN) TABLET [AIDAREX PHARMACEUTICALS LLC]	1
WARFARIN	ACTIVE MOIETY	5Q7ZVV76EI	WARFARIN SODIUM (WARFARIN) TABLET [AIDAREX PHARMACEUTICALS LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	WARFARIN SODIUM (WARFARIN) TABLET [AIDAREX PHARMACEUTICALS LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	WARFARIN SODIUM (WARFARIN) TABLET [AIDAREX PHARMACEUTICALS LLC]	1
HYDROXYPROPYL CELLULOSE (TYPE E)	INACTIVE INGREDIENT	66O7AQV0RT	WARFARIN SODIUM (WARFARIN) TABLET [AIDAREX PHARMACEUTICALS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	WARFARIN SODIUM (WARFARIN) TABLET [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	WARFARIN SODIUM (WARFARIN) TABLET [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	WARFARIN SODIUM (WARFARIN) TABLET [AIDAREX PHARMACEUTICALS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-768	WARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS LLC]	19	Current NDC, Legacy NDC, 3 package rows	20241031_558b7a0d-5490-4c1b-802e-3ab3f1efe760.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 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Warfarin Sodium	WARFARIN	A-S Medication Solutions	541c9a70-adaf-4ef3-94ba-ad4e70dfa057	2026-07-23	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
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 ndc (product): 65162-768
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
Warfarin Sodium	WARFARIN	Bryant Ranch Prepack	3dd9f8ce-75e0-426a-9d22-6af7742a0ca7	2023-12-14	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
855288	warfarin sodium 1 MG Oral Tablet	PSN	541c9a70-adaf-4ef3-94ba-ad4e70dfa057	51
855296	warfarin sodium 10 MG Oral Tablet	PSN	541c9a70-adaf-4ef3-94ba-ad4e70dfa057	51
855302	warfarin sodium 2 MG Oral Tablet	PSN	541c9a70-adaf-4ef3-94ba-ad4e70dfa057	51
855312	warfarin sodium 2.5 MG Oral Tablet	PSN	541c9a70-adaf-4ef3-94ba-ad4e70dfa057	51
855318	warfarin sodium 3 MG Oral Tablet	PSN	541c9a70-adaf-4ef3-94ba-ad4e70dfa057	51
855324	warfarin sodium 4 MG Oral Tablet	PSN	541c9a70-adaf-4ef3-94ba-ad4e70dfa057	51
855332	warfarin sodium 5 MG Oral Tablet	PSN	541c9a70-adaf-4ef3-94ba-ad4e70dfa057	51
855338	warfarin sodium 6 MG Oral Tablet	PSN	541c9a70-adaf-4ef3-94ba-ad4e70dfa057	51
855344	warfarin sodium 7.5 MG Oral Tablet	PSN	541c9a70-adaf-4ef3-94ba-ad4e70dfa057	51
855288	warfarin sodium 1 MG Oral Tablet	SCD	541c9a70-adaf-4ef3-94ba-ad4e70dfa057	51
855296	warfarin sodium 10 MG Oral Tablet	SCD	541c9a70-adaf-4ef3-94ba-ad4e70dfa057	51
855302	warfarin sodium 2 MG Oral Tablet	SCD	541c9a70-adaf-4ef3-94ba-ad4e70dfa057	51
855312	warfarin sodium 2.5 MG Oral Tablet	SCD	541c9a70-adaf-4ef3-94ba-ad4e70dfa057	51
855318	warfarin sodium 3 MG Oral Tablet	SCD	541c9a70-adaf-4ef3-94ba-ad4e70dfa057	51
855324	warfarin sodium 4 MG Oral Tablet	SCD	541c9a70-adaf-4ef3-94ba-ad4e70dfa057	51
855332	warfarin sodium 5 MG Oral Tablet	SCD	541c9a70-adaf-4ef3-94ba-ad4e70dfa057	51
855338	warfarin sodium 6 MG Oral Tablet	SCD	541c9a70-adaf-4ef3-94ba-ad4e70dfa057	51
855344	warfarin sodium 7.5 MG Oral Tablet	SCD	541c9a70-adaf-4ef3-94ba-ad4e70dfa057	51
855344	warfarin sodium 7.5 MG Oral Tablet	PSN	e11e4522-4b34-4170-af51-7b602924c746	1
855344	warfarin sodium 7.5 MG Oral Tablet	PSN	2f2119e8-f583-ba16-e063-6394a90a13a2	1
855344	warfarin sodium 7.5 MG Oral Tablet	SCD	e11e4522-4b34-4170-af51-7b602924c746	1
855344	warfarin sodium 7.5 MG Oral Tablet	SCD	2f2119e8-f583-ba16-e063-6394a90a13a2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-768-10	65162076810	100 TABLET in 1 BOTTLE (65162-768-10)	100 tablet	2010-08-16	0000-00-00	No	No	Current
65162-768-11	65162076811	1000 TABLET in 1 BOTTLE (65162-768-11)	1000 tablet	2010-08-16	0000-00-00	No	No	Current
65162-768-50	65162076850	500 TABLET in 1 BOTTLE (65162-768-50)	500 tablet	2010-08-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Warfarin Sodium	A-S Medication Solutions	2026-07-23	HUMAN PRESCRIPTION DRUG LABEL	54
Warfarin Sodium	REMEDYREPACK INC.	2026-06-29	HUMAN PRESCRIPTION DRUG LABEL	6
Warfarin Sodium	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals Private Limited	2026-05-29	HUMAN PRESCRIPTION DRUG LABEL	20
Warfarin Sodium	Coupler LLC	2025-02-27	HUMAN PRESCRIPTION DRUG LABEL	1
Warfarin Sodium	Bryant Ranch Prepack	2021-12-28	HUMAN PRESCRIPTION DRUG LABEL	2
Warfarin Sodium	Aidarex Pharmaceuticals LLC	2013-10-04	HUMAN PRESCRIPTION DRUG LABEL	1