Warfarin Sodium

Product NDC: 43353-050
11-digit product format: 433530050
Labeler code: 43353
Product ID: 43353-050_b2821ecc-6d75-4ea4-b57c-78ad508fe7e3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Warfarin Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA040301
Marketing category: ANDA
Marketing start: 1999-07-15
Marketing end: 0000-00-00
Substance: WARFARIN SODIUM
Active strength: 5 mg/1
Pharmacologic classes: Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

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 · 20 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43353-050		I	Inactivated by FDA	2026-08-17
excluded package	package	43353-050	43353-050-15	I	Inactivated by FDA	2026-08-17
excluded package	package	43353-050	43353-050-20	I	Inactivated by FDA	2026-08-17
excluded package	package	43353-050	43353-050-25	I	Inactivated by FDA	2026-08-17
excluded package	package	43353-050	43353-050-28	I	Inactivated by FDA	2026-08-17
excluded package	package	43353-050	43353-050-30	I	Inactivated by FDA	2026-08-17
excluded package	package	43353-050	43353-050-35	I	Inactivated by FDA	2026-08-17
excluded package	package	43353-050	43353-050-38	I	Inactivated by FDA	2026-08-17
excluded package	package	43353-050	43353-050-40	I	Inactivated by FDA	2026-08-17
excluded package	package	43353-050	43353-050-45	I	Inactivated by FDA	2026-08-17
excluded package	package	43353-050	43353-050-50	I	Inactivated by FDA	2026-08-17
excluded package	package	43353-050	43353-050-53	I	Inactivated by FDA	2026-08-17
excluded package	package	43353-050	43353-050-55	I	Inactivated by FDA	2026-08-17
excluded package	package	43353-050	43353-050-57	I	Inactivated by FDA	2026-08-17
excluded package	package	43353-050	43353-050-60	I	Inactivated by FDA	2026-08-17
excluded package	package	43353-050	43353-050-61	I	Inactivated by FDA	2026-08-17
excluded package	package	43353-050	43353-050-65	I	Inactivated by FDA	2026-08-17
excluded package	package	43353-050	43353-050-68	I	Inactivated by FDA	2026-08-17
excluded package	package	43353-050	43353-050-70	I	Inactivated by FDA	2026-08-17
excluded package	package	43353-050	43353-050-78	I	Inactivated by FDA	2026-08-17

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 7 · 420 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-050-61	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-050-53	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-050-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-050-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-050-65	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-050-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-050-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-050-68	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-050-70	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-050-78	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-050-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-050-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-050-35	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-050-38	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-050-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-050-57	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-050-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-050-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-050-55	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-050-61	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-050-53	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-050-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-050-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-050-65	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-050-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-050-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-050-68	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-050-70	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-050-78	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-050-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-050-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-050-35	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-050-38	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-050-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-050-57	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-050-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-050-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-050-55	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-050-61	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-050-53	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-050-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-050-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-050-65	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-050-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-050-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-050-68	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-050-70	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-050-78	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-050-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-050-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-050-35	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-050-38	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-050-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-050-57	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-050-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-050-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-050-55	`2ef7874e63bc…`	`57b86245f4fa…`

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
A040301-001	WARFARIN SODIUM	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	1999-07-15
A040301-002	WARFARIN SODIUM	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	1999-07-15
A040301-003	WARFARIN SODIUM	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	1999-07-15
A040301-004	WARFARIN SODIUM	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	1999-07-15
A040301-005	WARFARIN SODIUM	WARFARIN SODIUM	3MG	TABLET / ORAL	AB	1999-07-15
A040301-006	WARFARIN SODIUM	WARFARIN SODIUM	4MG	TABLET / ORAL	AB	1999-07-15
A040301-007	WARFARIN SODIUM	WARFARIN SODIUM	5MG	TABLET / ORAL	AB	1999-07-15
A040301-008	WARFARIN SODIUM	WARFARIN SODIUM	6MG	TABLET / ORAL	AB	1999-07-15
A040301-009	WARFARIN SODIUM	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB	1999-07-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040301-001	AB
A040301-002	AB
A040301-003	AB
A040301-004	AB
A040301-005	AB
A040301-006	AB
A040301-007	AB
A040301-008	AB
A040301-009	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	A040301-001	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	1999-07-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040301-002	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	1999-07-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040301-003	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	1999-07-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040301-004	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	1999-07-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040301-005	WARFARIN SODIUM	3MG	TABLET / ORAL	AB	1999-07-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040301-006	WARFARIN SODIUM	4MG	TABLET / ORAL	AB	1999-07-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040301-007	WARFARIN SODIUM	5MG	TABLET / ORAL	AB	1999-07-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040301-008	WARFARIN SODIUM	6MG	TABLET / ORAL	AB	1999-07-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040301-009	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB	1999-07-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040301-001	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	1999-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040301-002	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	1999-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040301-003	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	1999-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040301-004	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	1999-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040301-005	WARFARIN SODIUM	3MG	TABLET / ORAL	AB	1999-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040301-006	WARFARIN SODIUM	4MG	TABLET / ORAL	AB	1999-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040301-007	WARFARIN SODIUM	5MG	TABLET / ORAL	AB	1999-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040301-008	WARFARIN SODIUM	6MG	TABLET / ORAL	AB	1999-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040301-009	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB	1999-07-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040301-001	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	1999-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040301-002	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	1999-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040301-003	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	1999-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040301-004	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	1999-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040301-005	WARFARIN SODIUM	3MG	TABLET / ORAL	AB	1999-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040301-006	WARFARIN SODIUM	4MG	TABLET / ORAL	AB	1999-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040301-007	WARFARIN SODIUM	5MG	TABLET / ORAL	AB	1999-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040301-008	WARFARIN SODIUM	6MG	TABLET / ORAL	AB	1999-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040301-009	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB	1999-07-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040301-001	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	1999-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040301-002	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	1999-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040301-003	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	1999-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040301-004	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	1999-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040301-005	WARFARIN SODIUM	3MG	TABLET / ORAL	AB	1999-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040301-006	WARFARIN SODIUM	4MG	TABLET / ORAL	AB	1999-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040301-007	WARFARIN SODIUM	5MG	TABLET / ORAL	AB	1999-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040301-008	WARFARIN SODIUM	6MG	TABLET / ORAL	AB	1999-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040301-009	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB	1999-07-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040301-001	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	1999-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040301-002	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	1999-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040301-003	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	1999-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040301-004	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	1999-07-15	`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	A040301-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040301-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040301-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040301-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040301-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040301-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040301-007	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040301-008	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040301-009	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040301-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040301-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040301-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040301-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040301-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040301-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040301-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040301-008	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040301-009	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040301-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040301-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040301-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040301-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040301-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040301-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040301-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040301-008	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040301-009	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040301-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040301-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040301-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040301-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040301-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040301-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040301-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040301-008	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040301-009	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040301-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040301-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040301-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040301-004	AB	1	`fd3edfee7708…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
abcfe2f4-1eca-fdc3-341b-b8134a1aec1f	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
43353-050-15	Warfarin Sodium Tablets, USP Crystalline
43353-050-20	Warfarin Sodium Tablets, USP Crystalline
43353-050-25	Warfarin Sodium Tablets, USP Crystalline
43353-050-28	Warfarin Sodium Tablets, USP Crystalline
43353-050-30	Warfarin Sodium Tablets, USP Crystalline
43353-050-35	Warfarin Sodium Tablets, USP Crystalline
43353-050-38	Warfarin Sodium Tablets, USP Crystalline
43353-050-40	Warfarin Sodium Tablets, USP Crystalline
43353-050-45	Warfarin Sodium Tablets, USP Crystalline
43353-050-50	Warfarin Sodium Tablets, USP Crystalline
43353-050-53	Warfarin Sodium Tablets, USP Crystalline
43353-050-55	Warfarin Sodium Tablets, USP Crystalline
43353-050-57	Warfarin Sodium Tablets, USP Crystalline
43353-050-60	Warfarin Sodium Tablets, USP Crystalline
43353-050-61	Warfarin Sodium Tablets, USP Crystalline
43353-050-65	Warfarin Sodium Tablets, USP Crystalline
43353-050-68	Warfarin Sodium Tablets, USP Crystalline
43353-050-70	Warfarin Sodium Tablets, USP Crystalline
43353-050-78	Warfarin Sodium Tablets, USP Crystalline

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43353-050-15	Warfarin Sodium	15 in 1 BOTTLE, PLASTIC	TABLET	15	2
43353-050-20	Warfarin Sodium	20 in 1 BOTTLE, PLASTIC	TABLET	20	2
43353-050-25	Warfarin Sodium	25 in 1 BOTTLE, PLASTIC	TABLET	25	2
43353-050-28	Warfarin Sodium	28 in 1 BOTTLE, PLASTIC	TABLET	28	2
43353-050-30	Warfarin Sodium	30 in 1 BOTTLE, PLASTIC	TABLET	30	2
43353-050-35	Warfarin Sodium	35 in 1 BOTTLE, PLASTIC	TABLET	35	2
43353-050-38	Warfarin Sodium	55 in 1 BOTTLE, PLASTIC	TABLET	55	2
43353-050-40	Warfarin Sodium	40 in 1 BOTTLE, PLASTIC	TABLET	40	2
43353-050-45	Warfarin Sodium	45 in 1 BOTTLE, PLASTIC	TABLET	45	2
43353-050-50	Warfarin Sodium	50 in 1 BOTTLE, PLASTIC	TABLET	50	2
43353-050-53	Warfarin Sodium	60 in 1 BOTTLE, PLASTIC	TABLET	60	2
43353-050-55	Warfarin Sodium	75 in 1 BOTTLE, PLASTIC	TABLET	75	2
43353-050-57	Warfarin Sodium	80 in 1 BOTTLE, PLASTIC	TABLET	80	2
43353-050-60	Warfarin Sodium	90 in 1 BOTTLE, PLASTIC	TABLET	90	2
43353-050-61	Warfarin Sodium	70 in 1 BOTTLE, PLASTIC	TABLET	70	2
43353-050-65	Warfarin Sodium	100 in 1 BOTTLE, PLASTIC	TABLET	100	2
43353-050-68	Warfarin Sodium	26 in 1 BOTTLE, PLASTIC	TABLET	26	2
43353-050-70	Warfarin Sodium	120 in 1 BOTTLE, PLASTIC	TABLET	120	2
43353-050-78	Warfarin Sodium	34 in 1 BOTTLE, PLASTIC	TABLET	34	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-050-15	EA - Each	43353-050	238b4a89-9f4e-48d4-82ea-cc37fb579739	1	2013-02-13
43353-050-20	EA - Each	43353-050	c411da8e-eb3e-4afd-a80a-e5809d245a44	1	2013-02-13
43353-050-25	EA - Each	43353-050	49e5c798-6704-4cf5-bef0-d4b132b3d007	1	2013-02-13
43353-050-28	EA - Each	43353-050	b3895594-94ed-4cb3-b018-6459d5c72304	1	2013-02-13
43353-050-30	EA - Each	43353-050	73c6d98c-207d-4b8b-9699-f4fd4cf9c423	1	2013-02-13
43353-050-35	EA - Each	43353-050	e041847f-39d0-404b-9438-e6aac84ffcdc	1	2013-02-13
43353-050-38	EA - Each	43353-050	6d9de161-da6c-45b9-b7cd-f465468a3731	1	2013-02-13
43353-050-40	EA - Each	43353-050	e4dc43e8-b25c-490d-8f8a-9eadde4893e7	1	2013-02-13
43353-050-45	EA - Each	43353-050	8192640f-be34-468f-926d-a3aaae6561f1	1	2013-02-13
43353-050-50	EA - Each	43353-050	234de505-1e1a-4088-aed5-5d9bf6e5a6b4	1	2013-02-13
43353-050-53	EA - Each	43353-050	185208d1-4014-46c9-ae74-7d743658ed6e	1	2013-02-13
43353-050-55	EA - Each	43353-050	b4eb4a11-f4c4-4a1d-8b5e-48366eabca58	1	2013-02-13
43353-050-57	EA - Each	43353-050	69a9d5f8-2e34-432a-99b5-ff4dda562e8a	1	2013-02-13
43353-050-60	EA - Each	43353-050	0ac895bf-4463-4494-bec2-8622acd6db17	1	2013-02-13
43353-050-61	EA - Each	43353-050	b97c9ffb-fc53-4169-ae97-6bbdbf1c193f	1	2013-02-13
43353-050-65	EA - Each	43353-050	eeb48361-fb72-41ac-a509-00a7e1bcf422	1	2013-02-13
43353-050-68	EA - Each	43353-050	f85872d7-8929-4eda-964a-7e0e699736c3	1	2013-02-13
43353-050-70	EA - Each	43353-050	d1138db6-929c-4fa2-adf7-981a8ea9b8fe	1	2013-02-13
43353-050-78	EA - Each	43353-050	940302a1-3888-4e90-834c-8d3db1803a4c	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
WARFARIN SODIUM	ACTIVE INGREDIENT	6153CWM0CL	WARFARIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
WARFARIN	ACTIVE MOIETY	5Q7ZVV76EI	WARFARIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
Anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	WARFARIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
D&C RED NO. 6	INACTIVE INGREDIENT	481744AI4O	WARFARIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	WARFARIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	WARFARIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	WARFARIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	WARFARIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	WARFARIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	WARFARIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-050	WARFARIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Legacy NDC, 19 package rows	20140507_c437507c-d308-4aac-aa5e-a54972c7fa95.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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	bd6ea120-5d1c-4815-94f2-81e28dc6b7a9	2026-08-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040301 application number: ANDA040301
Warfarin Sodium	WARFARIN SODIUM	A-S Medication Solutions	8cd0e744-b499-4344-b1db-59f85950e169	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040301 application number: ANDA040301
Warfarin Sodium	WARFARIN SODIUM	A-S Medication Solutions	991b1e3e-236e-44cf-ad61-7233f777ce67	2026-06-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040301 application number: ANDA040301
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	6b227c9e-02e9-4ec9-8b11-3ab6fe5093e5	2026-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040301 application number: ANDA040301
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	72d3ea20-27e4-4368-a666-a9b76530dbb9	2026-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040301 application number: ANDA040301
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	61ab23a7-bc67-4777-854a-bf43c788a69a	2026-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040301 application number: ANDA040301
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	7b3b6f89-1feb-4939-a95b-7ad0707f4d76	2026-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040301 application number: ANDA040301
Warfarin Sodium	WARFARIN SODIUM	REMEDYREPACK INC.	73b8e5ab-86f8-44f8-b290-346acb81c9ae	2026-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040301 application number: ANDA040301
Warfarin Sodium	WARFARIN SODIUM	Cardinal Health 107, LLC	cdbbc317-35d3-42ba-94f0-c83891358529	2025-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040301 application number: ANDA040301
Warfarin Sodium	WARFARIN SODIUM	Bryant Ranch Prepack	694e258d-86bd-440c-870b-a7d27fb1c467	2025-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040301 application number: ANDA040301
Warfarin Sodium	WARFARIN SODIUM	Golden State Medical Supply, Inc.	ba8b4ead-d080-91e7-e053-2995a90a82fe	2025-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040301 application number: ANDA040301
Warfarin Sodium	WARFARIN SODIUM	Sun Pharmaceutical Industries, Inc.	8ad881e0-ca41-42ad-9d7d-eb85b3a30af0	2025-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040301 application number: ANDA040301
Warfarin Sodium	WARFARIN SODIUM	Cardinal Health 107, LLC	7c4deb97-9966-4c8e-9ba6-bb260b71e130	2025-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040301 application number: ANDA040301
Warfarin Sodium	WARFARIN SODIUM	American Health Packaging	ab047628-67d0-4a64-8d77-36b054969b44	2024-10-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040301 application number: ANDA040301
Warfarin Sodium	WARFARIN SODIUM	American Health Packaging	feaa5f6f-9753-4f37-ab81-04c9c6b45e6a	2024-10-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040301 application number: ANDA040301
Warfarin Sodium	WARFARIN SODIUM	Aphena Pharma Solutions - Tennessee, LLC	e73d37f8-8a28-4d93-9529-fd1e2c84228a	2021-08-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040301 application number: ANDA040301
Warfarin Sodium	WARFARIN SODIUM	Aphena Pharma Solutions - Tennessee, LLC	2c8f47c6-a180-4ad8-b962-04069d2270cb	2021-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040301 application number: ANDA040301

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6153CWM0CL	WARFARIN SODIUM	129-06-6	WARFARIN SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
855288	warfarin sodium 1 MG Oral Tablet	PSN	c437507c-d308-4aac-aa5e-a54972c7fa95	2
855296	warfarin sodium 10 MG Oral Tablet	PSN	c437507c-d308-4aac-aa5e-a54972c7fa95	2
855312	warfarin sodium 2.5 MG Oral Tablet	PSN	c437507c-d308-4aac-aa5e-a54972c7fa95	2
855318	warfarin sodium 3 MG Oral Tablet	PSN	c437507c-d308-4aac-aa5e-a54972c7fa95	2
855324	warfarin sodium 4 MG Oral Tablet	PSN	c437507c-d308-4aac-aa5e-a54972c7fa95	2
855332	warfarin sodium 5 MG Oral Tablet	PSN	c437507c-d308-4aac-aa5e-a54972c7fa95	2
855338	warfarin sodium 6 MG Oral Tablet	PSN	c437507c-d308-4aac-aa5e-a54972c7fa95	2
855344	warfarin sodium 7.5 MG Oral Tablet	PSN	c437507c-d308-4aac-aa5e-a54972c7fa95	2
855288	warfarin sodium 1 MG Oral Tablet	SCD	c437507c-d308-4aac-aa5e-a54972c7fa95	2
855296	warfarin sodium 10 MG Oral Tablet	SCD	c437507c-d308-4aac-aa5e-a54972c7fa95	2
855312	warfarin sodium 2.5 MG Oral Tablet	SCD	c437507c-d308-4aac-aa5e-a54972c7fa95	2
855318	warfarin sodium 3 MG Oral Tablet	SCD	c437507c-d308-4aac-aa5e-a54972c7fa95	2
855324	warfarin sodium 4 MG Oral Tablet	SCD	c437507c-d308-4aac-aa5e-a54972c7fa95	2
855332	warfarin sodium 5 MG Oral Tablet	SCD	c437507c-d308-4aac-aa5e-a54972c7fa95	2
855338	warfarin sodium 6 MG Oral Tablet	SCD	c437507c-d308-4aac-aa5e-a54972c7fa95	2
855344	warfarin sodium 7.5 MG Oral Tablet	SCD	c437507c-d308-4aac-aa5e-a54972c7fa95	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
43353-050-15	43353005015	15 in 1 BOTTLE, PLASTIC	Historical
43353-050-20	43353005020	20 in 1 BOTTLE, PLASTIC	Historical
43353-050-25	43353005025	25 in 1 BOTTLE, PLASTIC	Historical
43353-050-28	43353005028	28 in 1 BOTTLE, PLASTIC	Historical
43353-050-30	43353005030	30 in 1 BOTTLE, PLASTIC	Historical
43353-050-35	43353005035	35 in 1 BOTTLE, PLASTIC	Historical
43353-050-38	43353005038	55 in 1 BOTTLE, PLASTIC	Historical
43353-050-40	43353005040	40 in 1 BOTTLE, PLASTIC	Historical
43353-050-45	43353005045	45 in 1 BOTTLE, PLASTIC	Historical
43353-050-50	43353005050	50 in 1 BOTTLE, PLASTIC	Historical
43353-050-53	43353005053	60 in 1 BOTTLE, PLASTIC	Historical
43353-050-55	43353005055	75 in 1 BOTTLE, PLASTIC	Historical
43353-050-57	43353005057	80 in 1 BOTTLE, PLASTIC	Historical
43353-050-60	43353005060	90 in 1 BOTTLE, PLASTIC	Historical
43353-050-61	43353005061	70 in 1 BOTTLE, PLASTIC	Historical
43353-050-65	43353005065	100 in 1 BOTTLE, PLASTIC	Historical
43353-050-68	43353005068	26 in 1 BOTTLE, PLASTIC	Historical
43353-050-70	43353005070	120 in 1 BOTTLE, PLASTIC	Historical
43353-050-78	43353005078	34 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Warfarin Sodium Tablets, USP Crystalline	Aphena Pharma Solutions - Tennessee, LLC	2014-05-06	HUMAN PRESCRIPTION DRUG LABEL	2