Warfarin Sodium

Product NDC: 70518-2383
Requested package NDC: 70518-2383-3
11-digit product format: 705182383
Labeler code: 70518
Product ID: 70518-2383_4a152b72-65fd-e48b-e063-6394a90a1b84
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Warfarin
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA202202
Marketing category: ANDA
Marketing start: 2019-10-24
Substance: WARFARIN SODIUM
Active strength: 1 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A202202-001	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	2013-03-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202202-002	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	2013-03-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202202-003	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	2013-03-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202202-004	WARFARIN SODIUM	3MG	TABLET / ORAL	AB	2013-03-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202202-005	WARFARIN SODIUM	4MG	TABLET / ORAL	AB	2013-03-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202202-006	WARFARIN SODIUM	5MG	TABLET / ORAL	AB	2013-03-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202202-007	WARFARIN SODIUM	6MG	TABLET / ORAL	AB	2013-03-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202202-008	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB	2013-03-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202202-009	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	2013-03-04	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A202202-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202202-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202202-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202202-004	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202202-005	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202202-006	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202202-007	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202202-008	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202202-009	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 ndc (package): 70518-2383-3 ndc (product): 70518-2383 ndc11 (package): 70518238303
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
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

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	1 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
855288	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
a4cf3107-5646-4b91-8aae-94548e4409ef	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
70518-2383-0	Warfarin Sodium	100 in 1 BOX	TABLET	100	10
70518-2383-1	Warfarin Sodium	1 in 1 POUCH	TABLET	1	10
70518-2383-2	Warfarin Sodium	30 in 1 BOTTLE, PLASTIC	TABLET	30	10
70518-2383-3	Warfarin Sodium	30 in 1 BLISTER PACK	TABLET	30	10

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	a4cf3107-5646-4b91-8aae-94548e4409ef	10
855288	warfarin sodium 1 MG Oral Tablet	SCD	a4cf3107-5646-4b91-8aae-94548e4409ef	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-2383-3	70518238303	30 TABLET in 1 BLISTER PACK (70518-2383-3)	30 tablet	2025-06-06	No	No	Current