Fosinopril Sodium

Product NDC
0185-0041
11-digit product format
001850041
Labeler code
0185
Product ID
0185-0041_215dbdaf-a839-4617-ab08-2027369b1791
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fosinopril Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Eon Labs, Inc.
Application
ANDA076483
Marketing category
ANDA
Marketing start
2004-04-23
Marketing end
2020-08-31
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
0000-00-00
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0185-0041DDiscontinued by firm2026-08-17
excluded packagepackage0185-00410185-0041-09DDiscontinued by firm2026-08-17
excluded packagepackage0185-00410185-0041-10DDiscontinued by firm2026-08-17

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0185-0041-09d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0185-0041-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0185-0041-09f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0185-0041-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0185-0041-092ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0185-0041-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0185-0041-09a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0185-0041-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0185-0041-09cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0185-0041-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0185-0041-09cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0185-0041-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0185-0041-09302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0185-0041-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0185-0041-09ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0185-0041-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0185-0041-090efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0185-0041-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0185-0041-09ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0185-0041-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0185-0041-09367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0185-0041-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0185-0041-09557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0185-0041-10557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076483-001FOSINOPRIL SODIUMFOSINOPRIL SODIUM10MGTABLET / ORALAB2004-04-23
A076483-002FOSINOPRIL SODIUMFOSINOPRIL SODIUM20MGTABLET / ORALAB2004-04-23
A076483-003FOSINOPRIL SODIUMFOSINOPRIL SODIUM40MGTABLET / ORALAB2004-04-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076483-001AB
A076483-002AB
A076483-003AB

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076483-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2004-04-23caaa826d4ba7…
2026-08-18 06:07:402026-07A076483-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2004-04-23caaa826d4ba7…
2026-08-18 06:07:402026-07A076483-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2004-04-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076483-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2004-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076483-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2004-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076483-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2004-04-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076483-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2004-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076483-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2004-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076483-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2004-04-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A076483-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2004-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076483-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2004-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076483-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2004-04-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076483-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2004-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076483-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2004-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076483-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2004-04-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076483-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2004-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076483-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2004-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076483-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2004-04-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076483-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2004-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076483-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2004-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076483-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2004-04-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076483-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2004-04-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076483-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2004-04-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076483-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2004-04-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076483-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2004-04-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076483-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2004-04-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076483-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2004-04-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076483-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2004-04-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076483-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2004-04-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076483-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2004-04-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076483-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2004-04-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A076483-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2004-04-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A076483-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2004-04-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076483-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2004-04-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076483-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2004-04-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076483-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2004-04-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076483-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2004-04-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076483-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2004-04-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076483-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2004-04-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076483-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2004-04-231e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076483-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076483-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076483-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076483-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076483-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076483-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076483-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076483-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076483-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076483-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076483-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076483-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076483-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076483-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076483-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076483-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076483-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076483-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076483-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076483-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076483-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076483-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076483-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076483-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076483-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076483-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076483-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076483-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076483-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076483-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076483-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076483-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076483-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076483-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076483-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076483-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076483-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076483-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076483-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076483-001AB11e350fbaab3a…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0185-0041-09EA - Each0185-00413511c913-54f7-4c01-9157-1e3d19a403d112012-07-24
0185-0041-10EA - Each0185-00415243b964-544b-4df9-84a1-aed80cc20fdc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FOSINOPRIL SODIUMACTIVE INGREDIENTNW2RTH6T2NFOSINOPRIL SODIUM TABLET [EON LABS, INC.]15
FOSINOPRILATACTIVE MOIETYS312EY6ZT8FOSINOPRIL SODIUM TABLET [EON LABS, INC.]15
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKFOSINOPRIL SODIUM TABLET [EON LABS, INC.]15
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZFOSINOPRIL SODIUM TABLET [EON LABS, INC.]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFOSINOPRIL SODIUM TABLET [EON LABS, INC.]15
CROSPOVIDONEINACTIVE INGREDIENT68401960MKFOSINOPRIL SODIUM TABLET [EON LABS, INC.]15
ZINC STEARATEINACTIVE INGREDIENTH92E6QA4FVFOSINOPRIL SODIUM TABLET [EON LABS, INC.]15

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fosinopril SodiumFOSINOPRIL SODIUMChartwell RX, LLCff1323cc-7ad8-488d-94a7-a11555db78a72025-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076483
application number: ANDA076483