Fosinopril sodium

Product NDC
71335-1115
Requested package NDC
71335-1115-1
11-digit product format
713351115
Labeler code
71335
Product ID
71335-1115_fc84aca8-11a0-47d6-9069-70ff69377e4b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fosinopril sodium
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205670
Marketing category
ANDA
Marketing start
2017-10-01
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71335-111571335-1115-1DDiscontinued by firm2026-10-05
excluded packagepackage71335-111571335-1115-1IInactivated by FDA2026-10-05

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 · 27 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205670-001FOSINOPRIL SODIUMFOSINOPRIL SODIUM10MGTABLET / ORALAB2016-08-29
A205670-002FOSINOPRIL SODIUMFOSINOPRIL SODIUM20MGTABLET / ORALAB2016-08-29
A205670-003FOSINOPRIL SODIUMFOSINOPRIL SODIUM40MGTABLET / ORALAB2016-08-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205670-001AB
A205670-002AB
A205670-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A205670-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2016-08-2984e616aacf4f…
2026-09-14 22:38:342026-08A205670-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2016-08-2984e616aacf4f…
2026-09-14 22:38:342026-08A205670-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2016-08-2984e616aacf4f…
2026-08-18 06:07:402026-07A205670-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2016-08-29caaa826d4ba7…
2026-08-18 06:07:402026-07A205670-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2016-08-29caaa826d4ba7…
2026-08-18 06:07:402026-07A205670-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2016-08-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205670-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2016-08-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205670-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2016-08-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205670-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2016-08-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205670-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2016-08-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205670-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2016-08-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205670-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2016-08-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A205670-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2016-08-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205670-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2016-08-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205670-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2016-08-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205670-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2016-08-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205670-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2016-08-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205670-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2016-08-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205670-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2016-08-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205670-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2016-08-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205670-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2016-08-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205670-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2016-08-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205670-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2016-08-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205670-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2016-08-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205670-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2016-08-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205670-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2016-08-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205670-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2016-08-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205670-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2016-08-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205670-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2016-08-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205670-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2016-08-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205670-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2016-08-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205670-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2016-08-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205670-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2016-08-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205670-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2016-08-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A205670-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2016-08-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A205670-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2016-08-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205670-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2016-08-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205670-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2016-08-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205670-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2016-08-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205670-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2016-08-29301d65b070ca…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A205670-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A205670-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A205670-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A205670-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A205670-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A205670-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205670-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205670-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205670-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205670-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205670-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205670-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205670-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205670-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205670-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205670-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205670-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205670-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205670-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205670-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205670-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205670-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205670-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205670-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205670-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205670-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205670-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205670-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205670-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205670-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205670-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205670-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205670-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205670-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205670-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205670-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205670-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205670-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205670-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205670-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
90aa3f6a-97f0-be7e-d25b-b26d56ae287eProduct name320201015

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1115-1Fosinopril sodium30 in 1 BOTTLETABLET30100
71335-1115-2Fosinopril sodium28 in 1 BOTTLETABLET28100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1115FOSINOPRIL SODIUM TABLET [BRYANT RANCH PREPACK]100Legacy NDC, 2 package rows20220322_d3632783-58b1-4d73-9c35-e13fbb909ff9.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fosinopril sodiumFOSINOPIRL SODIUMBryant Ranch Prepack3d521d4d-29f8-40d7-971b-0efb68dfbff22023-11-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205670
application number: ANDA205670
Fosinopril sodiumFOSINOPRIL SODIUMA-S Medication Solutions46e3e4e8-c611-4d4f-ad57-050b4c01fcd82023-09-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205670
application number: ANDA205670
Fosinopril sodiumFOSINOPRIL SODIUMBryant Ranch Prepackee78de8e-22f4-4c3b-a721-e9464d704eda2023-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205670
application number: ANDA205670
Fosinopril sodiumFOSINOPIRL SODIUMSolco Healthcare LLC0a66f606-5e6f-473d-8a1e-9ef316adb2e22021-10-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205670
application number: ANDA205670

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857183fosinopril sodium 20 MG Oral TabletPSNd3632783-58b1-4d73-9c35-e13fbb909ff9100
857183fosinopril sodium 20 MG Oral TabletSCDd3632783-58b1-4d73-9c35-e13fbb909ff9100
857183FNP Sodium 20 MG Oral TabletSYd3632783-58b1-4d73-9c35-e13fbb909ff9100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1115-17133511150130 TABLET in 1 BOTTLE (71335-1115-1) 30 tablet2022-03-160000-00-00NoNoCurrent