Home NDC 62135-042 Fosinopril Sodium
Product NDC 62135-042
11-digit product format 621350042
Labeler code 62135
Product ID 62135-042_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 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 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# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 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 62135-042-90 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 62135-042 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 62135-042-90 62135004290 90 TABLET in 1 BOTTLE (62135-042-90) 90 tablet 2023-06-01 No No Current