Home NDC 62135-043 Fosinopril Sodium
Product NDC 62135-043
11-digit product format 621350043
Labeler code 62135
Product ID 62135-043_40d2b698-02dc-4589-e063-6394a90afb52
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fosinopril Sodium
Dosage form TABLET
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA076483
Marketing category ANDA
Marketing start 2004-04-23
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 1 .
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 A076483-001 FOSINOPRIL SODIUM FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2004-04-23 A076483-002 FOSINOPRIL SODIUM FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2004-04-23 A076483-003 FOSINOPRIL SODIUM FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2004-04-23
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 · 123 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 2026-02-19 14:30 UTC 2026-02 A076483-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2004-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076483-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2004-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076483-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2004-04-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076483-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2004-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076483-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2004-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076483-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2004-04-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076483-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2004-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076483-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2004-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076483-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2004-04-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076483-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2004-04-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076483-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2004-04-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076483-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2004-04-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076483-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2004-04-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076483-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2004-04-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076483-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2004-04-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076483-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2004-04-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076483-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2004-04-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076483-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2004-04-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076483-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2004-04-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076483-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2004-04-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076483-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2004-04-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076483-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2004-04-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076483-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2004-04-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076483-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2004-04-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076483-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2004-04-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076483-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2004-04-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076483-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2004-04-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076483-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2004-04-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076483-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2004-04-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076483-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2004-04-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076483-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2004-04-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076483-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2004-04-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076483-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2004-04-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076483-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2004-04-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076483-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2004-04-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076483-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2004-04-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076483-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2004-04-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076483-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2004-04-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076483-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2004-04-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076483-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2004-04-23 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
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.
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 40 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 62135-043-90 Fosinopril Sodium 90 in 1 BOTTLE TABLET 90 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-043 FOSINOPRIL SODIUM TABLET [CHARTWELL RX, LLC] 2 Current NDC, 1 package rows 20241030_ff1323cc-7ad8-488d-94a7-a11555db78a7.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 62135-043-90 62135004390 90 TABLET in 1 BOTTLE (62135-043-90) 90 tablet 2023-06-01 No No Current