Fosinopril Sodium

Product NDC: 68788-7717
Requested package NDC: 68788-7717-9
11-digit product format: 687887717
Labeler code: 68788
Product ID: 68788-7717_31ebef0f-0c0f-4d17-8da2-16a5fa56b05c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fosinopril
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA077222
Marketing category: ANDA
Marketing start: 2020-06-01
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: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68788-7717	68788-7717-9	D	Discontinued by firm		2026-09-14

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077222-001	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20
A077222-002	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20
A077222-003	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077222-001	AB
A077222-002	AB
A077222-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077222-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077222-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077222-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077222-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077222-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077222-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077222-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077222-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077222-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077222-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077222-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077222-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077222-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077222-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077222-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077222-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077222-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077222-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077222-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077222-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077222-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077222-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077222-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077222-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077222-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077222-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077222-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077222-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077222-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077222-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077222-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077222-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077222-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077222-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077222-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077222-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077222-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077222-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077222-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077222-001	AB	1	`301d65b070ca…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7717-1	EA - Each	68788-7717	012b1d7c-311e-4c62-bf48-1f084a102c3f	1	2020-08-06
68788-7717-3	EA - Each	68788-7717	ffc0ec31-ef02-4beb-9063-0e0cbe21ceec	1	2020-08-06
68788-7717-6	EA - Each	68788-7717	9efaef1d-7f08-436b-95d4-6339e8860dc9	1	2020-08-06
68788-7717-9	EA - Each	68788-7717	649b0db2-bfc9-413a-9fd3-f353326e5eaa	1	2020-08-06

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fosinopril Sodium	FOSINOPRIL	Bryant Ranch Prepack	fc38f1bb-f175-4a81-8ed9-c8701efdea35	2023-11-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077222 application number: ANDA077222
Fosinopril Sodium	FOSINOPRIL	Bryant Ranch Prepack	6562a532-b502-4515-88df-591d71293b56	2023-10-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077222 application number: ANDA077222
Fosinopril sodium	FOSINOPRIL SODIUM	Exelan Pharmaceuticals, Inc.	e2ff3171-a17a-456a-9272-ca1682b01d19	2023-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077222 application number: ANDA077222
Fosinopril Sodium	FOSINOPRIL	A-S Medication Solutions	880e5bf4-ced8-4765-a5c2-2361fd06ed9c	2023-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077222 application number: ANDA077222
Fosinopril Sodium	FOSINOPRIL	Cipla USA Inc.	736fe52f-69fb-48b2-b1c5-f06531878538	2023-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077222 application number: ANDA077222

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NW2RTH6T2N	FOSINOPRIL SODIUM	88889-14-9	FOSINOPRIL SODIUM
R43D2573WO	FOSINOPRIL	98048-97-6	Fosinopril

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7717-9	68788771709	90 TABLET in 1 BOTTLE (68788-7717-9)	90 tablet	2020-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FOSINOPRILSODIUM TABLETS, USP 10mg, 20mg and 40mg Rx Only	Preferred Pharmaceuticals, Inc.	2023-06-15	HUMAN PRESCRIPTION DRUG LABEL	4