Home NDC 76282-201 Fosinopril sodium
Product NDC 76282-201
11-digit product format 762820201
Labeler code 76282
Product ID 76282-201_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 20 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS 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.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 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…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077222-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2005-04-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077222-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2005-04-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077222-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2005-04-20 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
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 20 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 857169 Internal RxNorm lookup 857183 Internal RxNorm lookup 857187 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76282-201-10 Fosinopril sodium 1000 in 1 BOTTLE TABLET 1000 8 76282-201-90 Fosinopril sodium 90 in 1 BOTTLE TABLET 90 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FOSINOPRIL SODIUM ACTIVE INGREDIENT NW2RTH6T2N FOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 FOSINOPRIL SODIUM ACTIVE INGREDIENT NW2RTH6T2N FOSINOPRIL SODIUM TABLET [EXELAN PHARMACEUTICALS, INC.] 2 FOSINOPRILAT ACTIVE MOIETY S312EY6ZT8 FOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 FOSINOPRILAT ACTIVE MOIETY S312EY6ZT8 FOSINOPRIL SODIUM TABLET [EXELAN PHARMACEUTICALS, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FOSINOPRIL SODIUM TABLET [EXELAN PHARMACEUTICALS, INC.] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK FOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK FOSINOPRIL SODIUM TABLET [EXELAN PHARMACEUTICALS, INC.] 2 LACTOSE INACTIVE INGREDIENT J2B2A4N98G FOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 LACTOSE INACTIVE INGREDIENT J2B2A4N98G FOSINOPRIL SODIUM TABLET [EXELAN PHARMACEUTICALS, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FOSINOPRIL SODIUM TABLET [EXELAN PHARMACEUTICALS, INC.] 2 POVIDONE INACTIVE INGREDIENT FZ989GH94E FOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 POVIDONE INACTIVE INGREDIENT FZ989GH94E FOSINOPRIL SODIUM TABLET [EXELAN PHARMACEUTICALS, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76282-201 FOSINOPRIL SODIUM TABLET [EXELAN PHARMACEUTICALS, INC.] 8 Current NDC, Legacy NDC, 2 package rows 20230324_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 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 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 ndc (product): 76282-201 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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 76282-201-10 76282020110 1000 TABLET in 1 BOTTLE (76282-201-10) 1000 tablet 2005-06-21 0000-00-00 No No Current 76282-201-90 76282020190 90 TABLET in 1 BOTTLE (76282-201-90) 90 tablet 2005-06-21 0000-00-00 No No Current