Application 040663

Type: ANDA
Sponsor: ZYDUS PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	WARFARIN SODIUM	WARFARIN SODIUM	TABLET;ORAL	1MG	No	No
002	WARFARIN SODIUM	WARFARIN SODIUM	TABLET;ORAL	2MG	No	No
003	WARFARIN SODIUM	WARFARIN SODIUM	TABLET;ORAL	2.5MG	No	No
004	WARFARIN SODIUM	WARFARIN SODIUM	TABLET;ORAL	3MG	No	No
005	WARFARIN SODIUM	WARFARIN SODIUM	TABLET;ORAL	4MG	No	No
006	WARFARIN SODIUM	WARFARIN SODIUM	TABLET;ORAL	5MG	No	No
007	WARFARIN SODIUM	WARFARIN SODIUM	TABLET;ORAL	6MG	No	No
008	WARFARIN SODIUM	WARFARIN SODIUM	TABLET;ORAL	7.5MG	No	No
009	WARFARIN SODIUM	WARFARIN SODIUM	TABLET;ORAL	10MG	No	No

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
A040663-001	WARFARIN SODIUM	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	2006-05-30
A040663-002	WARFARIN SODIUM	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	2006-05-30
A040663-003	WARFARIN SODIUM	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	2006-05-30
A040663-004	WARFARIN SODIUM	WARFARIN SODIUM	3MG	TABLET / ORAL	AB	2006-05-30
A040663-005	WARFARIN SODIUM	WARFARIN SODIUM	4MG	TABLET / ORAL	AB	2006-05-30
A040663-006	WARFARIN SODIUM	WARFARIN SODIUM	5MG	TABLET / ORAL	AB	2006-05-30
A040663-007	WARFARIN SODIUM	WARFARIN SODIUM	6MG	TABLET / ORAL	AB	2006-05-30
A040663-008	WARFARIN SODIUM	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB	2006-05-30
A040663-009	WARFARIN SODIUM	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	2006-05-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040663-001	AB
A040663-002	AB
A040663-003	AB
A040663-004	AB
A040663-005	AB
A040663-006	AB
A040663-007	AB
A040663-008	AB
A040663-009	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	A040663-001	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	2006-05-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040663-002	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	2006-05-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040663-003	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	2006-05-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040663-004	WARFARIN SODIUM	3MG	TABLET / ORAL	AB	2006-05-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040663-005	WARFARIN SODIUM	4MG	TABLET / ORAL	AB	2006-05-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040663-006	WARFARIN SODIUM	5MG	TABLET / ORAL	AB	2006-05-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040663-007	WARFARIN SODIUM	6MG	TABLET / ORAL	AB	2006-05-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040663-008	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB	2006-05-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040663-009	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	2006-05-30	`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	A040663-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040663-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040663-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040663-004	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040663-005	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040663-006	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040663-007	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040663-008	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040663-009	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 4 · 73 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	Name fallback brand name: Warfarin Sodium
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	724b0061-f42a-4008-a078-09c800ee9785	2026-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Warfarin Sodium generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN	REMEDYREPACK INC.	d7fb4290-ed37-4ed3-ae51-c400191961dc	2026-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Warfarin Sodium
Warfarin Sodium	WARFARIN	REMEDYREPACK INC.	51e98fb6-ba76-497e-95d8-fe895ef0b7ed	2026-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Warfarin Sodium
Warfarin Sodium	WARFARIN	REMEDYREPACK INC.	a4cf3107-5646-4b91-8aae-94548e4409ef	2026-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Warfarin Sodium
Warfarin Sodium	WARFARIN	REMEDYREPACK INC.	2fb8b8d5-f643-4069-8e47-5eae31a8fbc8	2026-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Warfarin Sodium
Warfarin Sodium	WARFARIN	REMEDYREPACK INC.	884cdbf6-0a52-4126-8e14-b0d7c9367e33	2026-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Warfarin Sodium
Warfarin Sodium	WARFARIN	REMEDYREPACK INC.	8eddba53-19c4-411b-b0d4-cb2f948ba125	2026-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Warfarin Sodium
Warfarin Sodium	WARFARIN	REMEDYREPACK INC.	2cbcc99d-9107-4d39-a1e9-e19305de8b5d	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Warfarin Sodium
Warfarin Sodium	WARFARIN	REMEDYREPACK INC.	8ee94789-72d2-4c42-9dbd-0501e9767d97	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Warfarin Sodium
Warfarin Sodium	WARFARIN	REMEDYREPACK INC.	545ec40d-2db1-4581-b3ec-ce195e5f5400	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Warfarin Sodium
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	f5fb1a5f-0dda-4f47-8683-ea63ac88a69d	2026-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Warfarin Sodium generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	1244c338-9140-425a-bf2a-9da6b4ac0287	2026-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Warfarin Sodium generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	d6083d68-4360-4d47-a1b2-1eb2763024bb	2026-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Warfarin Sodium generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	4dc2d94e-f856-47da-9d44-24773d97eb87	2026-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Warfarin Sodium generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	ba65ae56-ca3b-4895-9938-1dde2c3d34bf	2026-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Warfarin Sodium generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	A-S Medication Solutions	8cd0e744-b499-4344-b1db-59f85950e169	2026-06-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Warfarin Sodium generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN SODIUM	A-S Medication Solutions	991b1e3e-236e-44cf-ad61-7233f777ce67	2026-06-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Warfarin Sodium generic name: WARFARIN SODIUM
Warfarin Sodium	WARFARIN	Amneal Pharmaceuticals LLC	558b7a0d-5490-4c1b-802e-3ab3f1efe760	2026-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Warfarin Sodium
Warfarin Sodium	WARFARIN	Coupler LLC	52bacf1e-9ba8-7eca-e063-6394a90ab60b	2026-05-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Warfarin Sodium

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 86 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-672	Warfarin Sodium	Warfarin Sodium	Rebel Distributors Corp	ANDA	Current
21695-673	Warfarin Sodium	Warfarin Sodium	Rebel Distributors Corp	ANDA	Current
21695-674	Warfarin Sodium	Warfarin Sodium	Rebel Distributors Corp	ANDA	Current
21695-675	Warfarin Sodium	Warfarin Sodium	Rebel Distributors Corp	ANDA	Current
21695-677	Warfarin Sodium	Warfarin Sodium	Rebel Distributors Corp	ANDA	Current
21695-801	Warfarin Sodium	Warfarin Sodium	Rebel Distributors Corp	ANDA	Current
21695-939	Warfarin Sodium	Warfarin Sodium	Rebel Distributors Corp	ANDA	Current
21695-940	Warfarin Sodium	Warfarin Sodium	Rebel Distributors Corp	ANDA	Current
50436-6357	Warfarin Sodium	Warfarin Sodium	Unit Dose Services	ANDA	Current
50436-6358	Warfarin Sodium	Warfarin Sodium	Unit Dose Services	ANDA	Current
50436-6360	Warfarin Sodium	Warfarin Sodium	Unit Dose Services	ANDA	Current
50436-6363	Warfarin Sodium	Warfarin Sodium	Unit Dose Services	ANDA	Current
50436-9933	Warfarin Sodium	Warfarin Sodium	Unit Dose Services	ANDA	Current
50436-9946	Warfarin Sodium	Warfarin Sodium	Unit Dose Services	ANDA	Current
51655-282	WARFARIN SODIUM	WARFARIN SODIUM	Northwind Pharmaceuticals, LLC	ANDA	Current
51655-283	WARFARIN SODIUM	WARFARIN SODIUM	Northwind Pharmaceuticals, LLC	ANDA	Current
53217-001	Warfarin Sodium	Warfarin Sodium	Aidarex Pharmaceuticals LLC	ANDA	Current
58517-360	warfarin sodium	warfarin sodium	New Horizon Rx Group, LLC	ANDA	Current
63629-3177	Warfarin Sodium	Warfarin Sodium	Bryant Ranch Prepack	ANDA	Current
63629-3177	Warfarin Sodium	Warfarin Sodium	Bryant Ranch Prepack	ANDA	Current
64725-0056	Warfarin Sodium	Warfarin Sodium	TYA Pharmaceuticals	ANDA	Current
65841-052	Warfarin Sodium	Warfarin Sodium	Cadila Healthcare Limited	ANDA	Current
65841-052	Warfarin Sodium	Warfarin Sodium	Cadila Healthcare Limited	ANDA	Current
65841-052	Warfarin Sodium	Warfarin Sodium	Cadila Healthcare Limited	ANDA	Current
65841-052	Warfarin Sodium	Warfarin Sodium	Zydus Lifesciences Limited	ANDA	Current
65841-053	Warfarin Sodium	Warfarin Sodium	Cadila Healthcare Limited	ANDA	Current
65841-053	Warfarin Sodium	Warfarin Sodium	Cadila Healthcare Limited	ANDA	Current
65841-053	Warfarin Sodium	Warfarin Sodium	Cadila Healthcare Limited	ANDA	Current
65841-053	Warfarin Sodium	Warfarin Sodium	Zydus Lifesciences Limited	ANDA	Current
65841-054	Warfarin Sodium	Warfarin Sodium	Cadila Healthcare Limited	ANDA	Current
65841-054	Warfarin Sodium	Warfarin Sodium	Cadila Healthcare Limited	ANDA	Current
65841-054	Warfarin Sodium	Warfarin Sodium	Cadila Healthcare Limited	ANDA	Current
65841-054	Warfarin Sodium	Warfarin Sodium	Zydus Lifesciences Limited	ANDA	Current
65841-055	Warfarin Sodium	Warfarin Sodium	Cadila Healthcare Limited	ANDA	Current
65841-055	Warfarin Sodium	Warfarin Sodium	Cadila Healthcare Limited	ANDA	Current
65841-055	Warfarin Sodium	Warfarin Sodium	Cadila Healthcare Limited	ANDA	Current
65841-055	Warfarin Sodium	Warfarin Sodium	Zydus Lifesciences Limited	ANDA	Current
65841-056	Warfarin Sodium	Warfarin Sodium	Cadila Healthcare Limited	ANDA	Current
65841-056	Warfarin Sodium	Warfarin Sodium	Cadila Healthcare Limited	ANDA	Current
65841-056	Warfarin Sodium	Warfarin Sodium	Cadila Healthcare Limited	ANDA	Current
65841-056	Warfarin Sodium	Warfarin Sodium	Zydus Lifesciences Limited	ANDA	Current
65841-057	Warfarin Sodium	Warfarin Sodium	Cadila Healthcare Limited	ANDA	Current
65841-057	Warfarin Sodium	Warfarin Sodium	Cadila Healthcare Limited	ANDA	Current
65841-057	Warfarin Sodium	Warfarin Sodium	Cadila Healthcare Limited	ANDA	Current
65841-057	Warfarin Sodium	Warfarin Sodium	Zydus Lifesciences Limited	ANDA	Current
65841-058	Warfarin Sodium	Warfarin Sodium	Cadila Healthcare Limited	ANDA	Current
65841-058	Warfarin Sodium	Warfarin Sodium	Cadila Healthcare Limited	ANDA	Current
65841-058	Warfarin Sodium	Warfarin Sodium	Cadila Healthcare Limited	ANDA	Current
65841-058	Warfarin Sodium	Warfarin Sodium	Zydus Lifesciences Limited	ANDA	Current
65841-059	Warfarin Sodium	Warfarin Sodium	Cadila Healthcare Limited	ANDA	Current
65841-059	Warfarin Sodium	Warfarin Sodium	Cadila Healthcare Limited	ANDA	Current
65841-059	Warfarin Sodium	Warfarin Sodium	Cadila Healthcare Limited	ANDA	Current
65841-059	Warfarin Sodium	Warfarin Sodium	Zydus Lifesciences Limited	ANDA	Current
65841-064	Warfarin Sodium	Warfarin Sodium	Cadila Healthcare Limited	ANDA	Current
65841-064	Warfarin Sodium	Warfarin Sodium	Cadila Healthcare Limited	ANDA	Current
65841-064	Warfarin Sodium	Warfarin Sodium	Cadila Healthcare Limited	ANDA	Current
65841-064	Warfarin Sodium	Warfarin Sodium	Zydus Lifesciences Limited	ANDA	Current
66267-285	Warfarin Sodium	Warfarin Sodium	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-285	Warfarin Sodium	Warfarin Sodium	NuCare Pharmaceuticals, Inc.	ANDA	Current
68382-052	Warfarin Sodium	Warfarin Sodium	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-052	Warfarin Sodium	Warfarin Sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-052	Warfarin Sodium	Warfarin Sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-053	Warfarin Sodium	Warfarin Sodium	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-053	Warfarin Sodium	Warfarin Sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-053	Warfarin Sodium	Warfarin Sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-054	Warfarin Sodium	Warfarin Sodium	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-054	Warfarin Sodium	Warfarin Sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-054	Warfarin Sodium	Warfarin Sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-055	Warfarin Sodium	Warfarin Sodium	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-055	Warfarin Sodium	Warfarin Sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-055	Warfarin Sodium	Warfarin Sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-056	Warfarin Sodium	Warfarin Sodium	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-056	Warfarin Sodium	Warfarin Sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-056	Warfarin Sodium	Warfarin Sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-057	Warfarin Sodium	Warfarin Sodium	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-057	Warfarin Sodium	Warfarin Sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-057	Warfarin Sodium	Warfarin Sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-058	Warfarin Sodium	Warfarin Sodium	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-058	Warfarin Sodium	Warfarin Sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-058	Warfarin Sodium	Warfarin Sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current