Fosinopril Sodium

Product NDC: 16571-770
11-digit product format: 165710770
Labeler code: 16571
Product ID: 16571-770_b472fd01-b492-4399-967d-ddfd4bb98faa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fosinopril Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA091163
Marketing category: ANDA
Marketing start: 2011-03-30
Marketing end: 0000-00-00
Substance: FOSINOPRIL SODIUM
Active strength: 10 mg/1
Pharmacologic classes: Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	16571-770		D	Discontinued by firm	2026-08-17
excluded package	package	16571-770	16571-770-09	D	Discontinued by firm	2026-08-17
excluded package	package	16571-770	16571-770-10	D	Discontinued by firm	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 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	16571-770-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	16571-770-09	`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	16571-770-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	16571-770-09	`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	16571-770-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	16571-770-09	`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	16571-770-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	16571-770-09	`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	16571-770-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	16571-770-09	`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	16571-770-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	16571-770-09	`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	16571-770-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	16571-770-09	`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	16571-770-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	16571-770-09	`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	16571-770-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	16571-770-09	`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	16571-770-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	16571-770-09	`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	16571-770-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	16571-770-09	`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	16571-770-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	16571-770-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A091163-001	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2011-03-30
A091163-002	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2011-03-30
A091163-003	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2011-03-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091163-001	AB
A091163-002	AB
A091163-003	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 · 126 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	A091163-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2011-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091163-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2011-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091163-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2011-03-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091163-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2011-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091163-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2011-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091163-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2011-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091163-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2011-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091163-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2011-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091163-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2011-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091163-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2011-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091163-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2011-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091163-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2011-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091163-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2011-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091163-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2011-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091163-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2011-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091163-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2011-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091163-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2011-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091163-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2011-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091163-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2011-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091163-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2011-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091163-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2011-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091163-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2011-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091163-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2011-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091163-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2011-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091163-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2011-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091163-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2011-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091163-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2011-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091163-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2011-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091163-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2011-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091163-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2011-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091163-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2011-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091163-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2011-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091163-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2011-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091163-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2011-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091163-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2011-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091163-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2011-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091163-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2011-03-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091163-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2011-03-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091163-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2011-03-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091163-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2011-03-30	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A091163-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091163-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091163-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091163-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091163-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091163-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091163-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091163-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091163-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091163-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091163-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091163-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091163-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091163-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091163-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091163-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091163-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091163-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091163-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091163-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091163-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091163-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091163-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091163-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091163-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091163-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091163-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091163-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091163-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091163-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091163-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091163-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091163-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091163-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091163-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091163-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091163-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091163-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091163-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091163-001	AB	1	`1e350fbaab3a…`

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	Aurobindo Pharma Limited	aee04f17-8ee9-42f5-861f-b6ba17220ca4	2024-05-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091163 application number: ANDA091163

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NW2RTH6T2N	FOSINOPRIL SODIUM	88889-14-9	FOSINOPRIL SODIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16571-770-09	16571077009	90 TABLET in 1 BOTTLE (16571-770-09)	90 tablet	2011-03-30	0000-00-00	No	No	Current
16571-770-10	16571077010	1000 TABLET in 1 BOTTLE (16571-770-10)	1000 tablet	2011-03-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fosinopril Sodium Tablets, USP Rx only	Rising Pharma Holdings, Inc. \| Aurobindo Pharma Limited	2021-04-05	Human Prescription Drug Label	1