Fosinopril sodium

Product NDC
76282-202
11-digit product format
762820202
Labeler code
76282
Product ID
76282-202_ed121c1b-359c-471e-913c-4afdf9102c34
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fosinopril sodium
Dosage form
TABLET
Route
ORAL
Labeler
Exelan Pharmaceuticals, Inc.
Application
ANDA077222
Marketing category
ANDA
Marketing start
2005-06-21
Substance
FOSINOPRIL SODIUM
Active strength
40 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

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
A077222-001FOSINOPRIL SODIUMFOSINOPRIL SODIUM10MGTABLET / ORALAB2005-04-20
A077222-002FOSINOPRIL SODIUMFOSINOPRIL SODIUM20MGTABLET / ORALAB2005-04-20
A077222-003FOSINOPRIL SODIUMFOSINOPRIL SODIUM40MGTABLET / ORALAB2005-04-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077222-001AB
A077222-002AB
A077222-003AB

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 06:07:402026-07A077222-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2005-04-20caaa826d4ba7…
2026-08-18 06:07:402026-07A077222-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2005-04-20caaa826d4ba7…
2026-08-18 06:07:402026-07A077222-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2005-04-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077222-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2005-04-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077222-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2005-04-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077222-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2005-04-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077222-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2005-04-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077222-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2005-04-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077222-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2005-04-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A077222-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2005-04-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077222-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2005-04-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077222-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2005-04-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077222-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2005-04-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077222-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2005-04-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077222-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2005-04-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077222-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2005-04-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077222-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2005-04-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077222-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2005-04-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077222-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2005-04-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077222-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2005-04-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077222-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2005-04-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077222-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2005-04-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077222-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2005-04-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077222-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2005-04-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077222-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2005-04-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077222-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2005-04-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077222-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2005-04-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077222-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2005-04-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077222-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2005-04-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077222-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2005-04-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077222-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2005-04-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A077222-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2005-04-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A077222-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2005-04-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077222-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2005-04-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077222-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2005-04-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077222-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2005-04-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077222-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2005-04-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077222-002FOSINOPRIL SODIUM20MGTABLET / ORALAB2005-04-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077222-003FOSINOPRIL SODIUM40MGTABLET / ORALAB2005-04-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077222-001FOSINOPRIL SODIUM10MGTABLET / ORALAB2005-04-201e350fbaab3a…

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 06:07:402026-07A077222-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077222-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077222-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077222-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077222-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077222-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077222-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077222-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077222-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077222-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077222-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077222-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077222-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077222-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077222-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077222-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077222-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077222-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077222-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077222-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077222-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077222-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077222-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077222-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077222-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077222-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077222-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077222-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077222-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077222-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077222-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077222-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077222-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077222-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077222-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077222-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077222-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077222-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077222-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077222-001AB11e350fbaab3a…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FOSINOPRIL SODIUM40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
NW2RTH6T2NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
857169Internal RxNorm lookup
857183Internal RxNorm lookup
857187Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e2ff3171-a17a-456a-9272-ca1682b01d19Available on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
76282-202-102023-03-23Rx only
76282-202-902023-03-23Rx only
76282-202-102023-01-30Rx only
76282-202-902023-01-30Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76282-202-10Fosinopril sodium1000 in 1 BOTTLETABLET10008
76282-202-90Fosinopril sodium90 in 1 BOTTLETABLET908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-202-10EA - Each76282-202d5e927a0-a721-40bc-a1d4-2e66604150a312012-07-24
76282-202-90EA - Each76282-202d9644026-853c-4fea-a4a8-caf26adbf3c312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FOSINOPRIL SODIUMACTIVE INGREDIENTNW2RTH6T2NFOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FOSINOPRIL SODIUMACTIVE INGREDIENTNW2RTH6T2NFOSINOPRIL SODIUM TABLET [EXELAN PHARMACEUTICALS, INC.]2
FOSINOPRILATACTIVE MOIETYS312EY6ZT8FOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FOSINOPRILATACTIVE MOIETYS312EY6ZT8FOSINOPRIL SODIUM TABLET [EXELAN PHARMACEUTICALS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFOSINOPRIL SODIUM TABLET [EXELAN PHARMACEUTICALS, INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKFOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKFOSINOPRIL SODIUM TABLET [EXELAN PHARMACEUTICALS, INC.]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GFOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GFOSINOPRIL SODIUM TABLET [EXELAN PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FOSINOPRIL SODIUM TABLET [EXELAN PHARMACEUTICALS, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EFOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EFOSINOPRIL SODIUM TABLET [EXELAN PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-202FOSINOPRIL SODIUM TABLET [EXELAN PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 2 package rows20230324_e2ff3171-a17a-456a-9272-ca1682b01d19.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fosinopril SodiumFOSINOPRILBryant Ranch Prepackfc38f1bb-f175-4a81-8ed9-c8701efdea352023-11-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077222
application number: ANDA077222
Fosinopril SodiumFOSINOPRILBryant Ranch Prepack6562a532-b502-4515-88df-591d71293b562023-10-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077222
application number: ANDA077222
Fosinopril sodiumFOSINOPRIL SODIUMExelan Pharmaceuticals, Inc.e2ff3171-a17a-456a-9272-ca1682b01d192023-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077222
application number: ANDA077222
ndc (product): 76282-202
Fosinopril SodiumFOSINOPRILA-S Medication Solutions880e5bf4-ced8-4765-a5c2-2361fd06ed9c2023-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077222
application number: ANDA077222
Fosinopril SodiumFOSINOPRILCipla USA Inc.736fe52f-69fb-48b2-b1c5-f065318785382023-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077222
application number: ANDA077222

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857169fosinopril sodium 10 MG Oral TabletPSNe2ff3171-a17a-456a-9272-ca1682b01d198
857183fosinopril sodium 20 MG Oral TabletPSNe2ff3171-a17a-456a-9272-ca1682b01d198
857187fosinopril sodium 40 MG Oral TabletPSNe2ff3171-a17a-456a-9272-ca1682b01d198
857169fosinopril sodium 10 MG Oral TabletSCDe2ff3171-a17a-456a-9272-ca1682b01d198
857183fosinopril sodium 20 MG Oral TabletSCDe2ff3171-a17a-456a-9272-ca1682b01d198
857187fosinopril sodium 40 MG Oral TabletSCDe2ff3171-a17a-456a-9272-ca1682b01d198
857169FNP Sodium 10 MG Oral TabletSYe2ff3171-a17a-456a-9272-ca1682b01d198
857183FNP Sodium 20 MG Oral TabletSYe2ff3171-a17a-456a-9272-ca1682b01d198
857187FNP Sodium 40 MG Oral TabletSYe2ff3171-a17a-456a-9272-ca1682b01d198
857187fosinopril sodium 40 MG Oral TabletPSN41d4f5a7-8477-4f31-834a-29457b33ee412
857187fosinopril sodium 40 MG Oral TabletSCD41d4f5a7-8477-4f31-834a-29457b33ee412
857187FNP Sodium 40 MG Oral TabletSY41d4f5a7-8477-4f31-834a-29457b33ee412
857169fosinopril sodium 10 MG Oral TabletPSN0cef0cd4-e952-40c8-b715-bce4d2f02c511
857187fosinopril sodium 40 MG Oral TabletPSN0cef0cd4-e952-40c8-b715-bce4d2f02c511
857169fosinopril sodium 10 MG Oral TabletSCD0cef0cd4-e952-40c8-b715-bce4d2f02c511
857187fosinopril sodium 40 MG Oral TabletSCD0cef0cd4-e952-40c8-b715-bce4d2f02c511
857169FNP Sodium 10 MG Oral TabletSY0cef0cd4-e952-40c8-b715-bce4d2f02c511
857187FNP Sodium 40 MG Oral TabletSY0cef0cd4-e952-40c8-b715-bce4d2f02c511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76282-202-10762820202101000 TABLET in 1 BOTTLE (76282-202-10) 1000 tablet2005-06-210000-00-00NoNoCurrent
76282-202-907628202029090 TABLET in 1 BOTTLE (76282-202-90) 90 tablet2005-06-210000-00-00NoNoCurrent