Fosinopril Sodium

Product NDC: 65862-471
Requested package NDC: 65862-471-99
11-digit product format: 658620471
Labeler code: 65862
Product ID: 65862-471_8767ee1b-3d50-4a6f-bb59-6c15ccfde78d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fosinopril Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA091163
Marketing category: ANDA
Marketing start: 2011-03-30
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: 2027-12-31
Current FDA listing: Yes

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
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 · 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	A091163-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2011-03-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091163-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2011-03-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091163-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2011-03-30	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A091163-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2011-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091163-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2011-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091163-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2011-03-30	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091163-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091163-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091163-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091163-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091163-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091163-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091163-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091163-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091163-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091163-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091163-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091163-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091163-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091163-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091163-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091163-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091163-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091163-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091163-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091163-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091163-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091163-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091163-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091163-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091163-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091163-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091163-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091163-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091163-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091163-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091163-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091163-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091163-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091163-002	AB	1	`c0c555d07b60…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Fosinopril Sodium
Listing expiration: 2027-12-31

Active Ingredients#

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

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
65862-471-30	Fosinopril Sodium	30 in 1 BOTTLE	TABLET	30	8
65862-471-90	Fosinopril Sodium	90 in 1 BOTTLE	TABLET	90	8
65862-471-99	Fosinopril Sodium	1000 in 1 BOTTLE	TABLET	1000	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-471-90	EA - Each	65862-471	ff5065a8-fbc6-4886-ba95-83e1ab3c8a55	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FOSINOPRIL SODIUM	ACTIVE INGREDIENT	NW2RTH6T2N	FOSINOPRIL SODIUM TABLET [AUROBINDO PHARMA LIMITED]	5
FOSINOPRILAT	ACTIVE MOIETY	S312EY6ZT8	FOSINOPRIL SODIUM TABLET [AUROBINDO PHARMA LIMITED]	5
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	FOSINOPRIL SODIUM TABLET [AUROBINDO PHARMA LIMITED]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FOSINOPRIL SODIUM TABLET [AUROBINDO PHARMA LIMITED]	5
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	FOSINOPRIL SODIUM TABLET [AUROBINDO PHARMA LIMITED]	5
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	FOSINOPRIL SODIUM TABLET [AUROBINDO PHARMA LIMITED]	5
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	FOSINOPRIL SODIUM TABLET [AUROBINDO PHARMA LIMITED]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-471	FOSINOPRIL SODIUM TABLET [AUROBINDO PHARMA LIMITED]	8	Current NDC, Legacy NDC, 3 package rows	20240518_aee04f17-8ee9-42f5-861f-b6ba17220ca4.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
857169	fosinopril sodium 10 MG Oral Tablet	PSN	aee04f17-8ee9-42f5-861f-b6ba17220ca4	8
857183	fosinopril sodium 20 MG Oral Tablet	PSN	aee04f17-8ee9-42f5-861f-b6ba17220ca4	8
857187	fosinopril sodium 40 MG Oral Tablet	PSN	aee04f17-8ee9-42f5-861f-b6ba17220ca4	8
857169	fosinopril sodium 10 MG Oral Tablet	SCD	aee04f17-8ee9-42f5-861f-b6ba17220ca4	8
857183	fosinopril sodium 20 MG Oral Tablet	SCD	aee04f17-8ee9-42f5-861f-b6ba17220ca4	8
857187	fosinopril sodium 40 MG Oral Tablet	SCD	aee04f17-8ee9-42f5-861f-b6ba17220ca4	8
857169	FNP Sodium 10 MG Oral Tablet	SY	aee04f17-8ee9-42f5-861f-b6ba17220ca4	8
857183	FNP Sodium 20 MG Oral Tablet	SY	aee04f17-8ee9-42f5-861f-b6ba17220ca4	8
857187	FNP Sodium 40 MG Oral Tablet	SY	aee04f17-8ee9-42f5-861f-b6ba17220ca4	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-471-99	65862047199	1000 TABLET in 1 BOTTLE (65862-471-99)	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	Aurobindo Pharma Limited	2026-10-12	Human Prescription Drug Label	9