Home NDC 43547-387 Fosinopril sodium
Product NDC 43547-387
11-digit product format 435470387
Labeler code 43547
Product ID 43547-387_e39b61db-42b8-4ddf-89d1-549c08d49e71
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fosinopril sodium
Dosage form TABLET
Route ORAL
Labeler Solco Healthcare LLC
Application ANDA205670
Marketing category ANDA
Marketing start 2017-10-01
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 A205670-001 FOSINOPRIL SODIUM FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2016-08-29 A205670-002 FOSINOPRIL SODIUM FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2016-08-29 A205670-003 FOSINOPRIL SODIUM FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2016-08-29
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 A205670-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2016-08-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205670-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2016-08-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205670-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2016-08-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205670-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2016-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205670-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2016-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205670-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2016-08-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205670-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2016-08-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205670-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2016-08-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205670-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2016-08-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205670-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2016-08-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205670-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2016-08-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205670-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2016-08-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205670-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2016-08-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205670-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2016-08-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205670-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2016-08-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205670-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2016-08-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205670-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2016-08-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205670-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2016-08-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205670-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2016-08-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205670-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2016-08-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205670-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2016-08-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205670-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2016-08-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205670-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2016-08-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205670-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2016-08-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205670-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2016-08-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205670-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2016-08-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205670-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2016-08-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205670-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2016-08-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205670-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2016-08-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205670-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2016-08-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205670-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2016-08-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205670-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2016-08-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205670-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2016-08-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205670-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2016-08-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205670-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2016-08-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205670-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2016-08-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205670-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2016-08-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205670-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2016-08-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205670-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2016-08-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205670-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2016-08-29 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43547-387-09 Fosinopril sodium 90 in 1 BOTTLE TABLET 90 3 43547-387-11 Fosinopril sodium 1000 in 1 BOTTLE TABLET 1000 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43547-387 FOSINOPRIL SODIUM (FOSINOPIRL SODIUM) TABLET FOSINOPRIL SODIUM TABLET [SOLCO HEALTHCARE LLC] 2 Current NDC, Legacy NDC, 2 package rows 20200120_0a66f606-5e6f-473d-8a1e-9ef316adb2e2.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Fosinopril sodium FOSINOPIRL SODIUM Bryant Ranch Prepack 3d521d4d-29f8-40d7-971b-0efb68dfbff2 2023-11-27 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 205670 application number: ANDA205670 Fosinopril sodium FOSINOPRIL SODIUM A-S Medication Solutions 46e3e4e8-c611-4d4f-ad57-050b4c01fcd8 2023-09-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 205670 application number: ANDA205670 Fosinopril sodium FOSINOPRIL SODIUM Bryant Ranch Prepack ee78de8e-22f4-4c3b-a721-e9464d704eda 2023-05-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 205670 application number: ANDA205670 Fosinopril sodium FOSINOPIRL SODIUM Solco Healthcare LLC 0a66f606-5e6f-473d-8a1e-9ef316adb2e2 2021-10-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 205670 application number: ANDA205670 ndc (product): 43547-387
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 43547-387-09 43547038709 90 TABLET in 1 BOTTLE (43547-387-09) 90 tablet 2017-10-01 0000-00-00 No No Current 43547-387-11 43547038711 1000 TABLET in 1 BOTTLE (43547-387-11) 1000 tablet 2017-10-01 0000-00-00 No No Current