Fosinopril Sodium

Product NDC: 71335-0381
Requested package NDC: 71335-0381-3
11-digit product format: 713350381
Labeler code: 71335
Product ID: 71335-0381_45aabe20-10c6-4b99-989a-2b64bd266114
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fosinopril
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA077222
Marketing category: ANDA
Marketing start: 2016-06-16
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: 2026-12-31
Current FDA listing: Yes

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	71335-0381	71335-0381-3	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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Fosinopril Sodium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FOSINOPRIL SODIUM	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
NW2RTH6T2N	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
857169	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
fc38f1bb-f175-4a81-8ed9-c8701efdea35	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
90aa3f6a-97f0-be7e-d25b-b26d56ae287e	Product name	3	20201015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-0381-1	Fosinopril Sodium	30 in 1 BOTTLE	TABLET	30	102
71335-0381-2	Fosinopril Sodium	90 in 1 BOTTLE	TABLET	90	102
71335-0381-3	Fosinopril Sodium	60 in 1 BOTTLE	TABLET	60	102
71335-0381-4	Fosinopril Sodium	28 in 1 BOTTLE	TABLET	28	102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-0381-1	EA - Each	71335-0381	301d595d-b23f-4d34-b5ae-4ae820ee03cb	1	2018-03-08
71335-0381-2	EA - Each	71335-0381	1a533fee-bf81-46ff-9776-72a3a41fe560	1	2018-03-08
71335-0381-3	EA - Each	71335-0381	38611baa-8eec-4b8f-a29e-cedd867519b0	1	2018-03-08
71335-0381-4	EA - Each	71335-0381	d474dd70-da39-4b4a-aad5-49a77119642e	1	2018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-0381	FOSINOPRIL SODIUM (FOSINOPRIL) TABLET [BRYANT RANCH PREPACK]	102	Current NDC, Legacy NDC, 4 package rows	20231128_fc38f1bb-f175-4a81-8ed9-c8701efdea35.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 · 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 ndc (package): 71335-0381-3 ndc (product): 71335-0381 ndc11 (package): 71335038103
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
857169	fosinopril sodium 10 MG Oral Tablet	PSN	fc38f1bb-f175-4a81-8ed9-c8701efdea35	102
857169	fosinopril sodium 10 MG Oral Tablet	SCD	fc38f1bb-f175-4a81-8ed9-c8701efdea35	102
857169	FNP Sodium 10 MG Oral Tablet	SY	fc38f1bb-f175-4a81-8ed9-c8701efdea35	102

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0381-3	71335038103	60 TABLET in 1 BOTTLE (71335-0381-3)	60 tablet	2022-02-09	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	Bryant Ranch Prepack	2023-11-27	HUMAN PRESCRIPTION DRUG LABEL	102