Fosinopril Sodium

Product NDC: 67544-322
11-digit product format: 675440322
Labeler code: 67544
Product ID: 67544-322_1e4cd5c0-6b72-4fae-a4c7-95f8ef34cc87
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fosinopril Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, Inc.
Application: ANDA076483
Marketing category: ANDA
Marketing start: 2004-04-23
Marketing end: 0000-00-00
Substance: FOSINOPRIL SODIUM
Active strength: 20 mg/1
Pharmacologic classes: Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	67544-322		D	Discontinued by firm	2026-10-16
excluded package	package	67544-322	67544-322-30	D	Discontinued by firm	2026-10-16
excluded package	package	67544-322	67544-322-45	D	Discontinued by firm	2026-10-16

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 1 · 36 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	67544-322-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-322-45	`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	67544-322-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-322-45	`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	67544-322-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-322-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-322-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-322-45	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-322-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-322-45	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67544-322-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67544-322-45	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67544-322-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67544-322-45	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67544-322-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67544-322-45	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67544-322-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67544-322-45	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67544-322-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67544-322-45	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67544-322-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67544-322-45	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67544-322-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67544-322-45	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A076483-001	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2004-04-23
A076483-002	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2004-04-23
A076483-003	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2004-04-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A076483-001	AB
A076483-002	AB
A076483-003	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 4 · 132 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
2026-10-15 13:18:30	2026-09	A076483-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2004-04-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076483-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2004-04-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076483-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2004-04-23	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A076483-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2004-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076483-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2004-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076483-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2004-04-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076483-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2004-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076483-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2004-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076483-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2004-04-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076483-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2004-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076483-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2004-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076483-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2004-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076483-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2004-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076483-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2004-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076483-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2004-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076483-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2004-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076483-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2004-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076483-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2004-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076483-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2004-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076483-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2004-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076483-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2004-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076483-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2004-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076483-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2004-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076483-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2004-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076483-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2004-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076483-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2004-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076483-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2004-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076483-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2004-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076483-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2004-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076483-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2004-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076483-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2004-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076483-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2004-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076483-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2004-04-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076483-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2004-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076483-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2004-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076483-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2004-04-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076483-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2004-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076483-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2004-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076483-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2004-04-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076483-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2004-04-23	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A076483-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A076483-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A076483-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076483-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A076483-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A076483-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076483-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076483-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076483-003	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076483-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076483-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076483-003	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67544-322-30	EA - Each	67544-322	b479899b-34e6-42e0-906c-a07912a600ad	1	2013-02-13
67544-322-45	EA - Each	67544-322	9efbb7c0-dab3-4dfe-8654-9888760d677b	1	2013-02-13

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fosinopril Sodium	FOSINOPRIL SODIUM	Chartwell RX, LLC	ff1323cc-7ad8-488d-94a7-a11555db78a7	2025-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076483 application number: ANDA076483