Home NDC 0185-0042 Fosinopril Sodium
Product NDC 0185-0042
11-digit product format 001850042
Labeler code 0185
Product ID 0185-0042_215dbdaf-a839-4617-ab08-2027369b1791
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fosinopril Sodium
Dosage form TABLET
Route ORAL
Labeler Eon Labs, Inc.
Application ANDA076483
Marketing category ANDA
Marketing start 2004-04-23
Marketing end 2020-09-30
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 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 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 · 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 A076483-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2004-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076483-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2004-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076483-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2004-04-23 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FOSINOPRIL SODIUM ACTIVE INGREDIENT NW2RTH6T2N FOSINOPRIL SODIUM TABLET [EON LABS, INC.] 15 FOSINOPRILAT ACTIVE MOIETY S312EY6ZT8 FOSINOPRIL SODIUM TABLET [EON LABS, INC.] 15 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK FOSINOPRIL SODIUM TABLET [EON LABS, INC.] 15 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ FOSINOPRIL SODIUM TABLET [EON LABS, INC.] 15 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FOSINOPRIL SODIUM TABLET [EON LABS, INC.] 15 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK FOSINOPRIL SODIUM TABLET [EON LABS, INC.] 15 ZINC STEARATE INACTIVE INGREDIENT H92E6QA4FV FOSINOPRIL SODIUM TABLET [EON LABS, INC.] 15 FOSINOPRIL SODIUM ACTIVE INGREDIENT NW2RTH6T2N FOSINOPRIL SODIUM TABLET [DISPENSING SOLUTIONS, INC.] 5 FOSINOPRILAT ACTIVE MOIETY S312EY6ZT8 FOSINOPRIL SODIUM TABLET [DISPENSING SOLUTIONS, INC.] 5 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK FOSINOPRIL SODIUM TABLET [DISPENSING SOLUTIONS, INC.] 5 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ FOSINOPRIL SODIUM TABLET [DISPENSING SOLUTIONS, INC.] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FOSINOPRIL SODIUM TABLET [DISPENSING SOLUTIONS, INC.] 5 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK FOSINOPRIL SODIUM TABLET [DISPENSING SOLUTIONS, INC.] 5 ZINC STEARATE INACTIVE INGREDIENT H92E6QA4FV FOSINOPRIL SODIUM TABLET [DISPENSING SOLUTIONS, INC.] 5
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.
DailyMed RxNorm Mappings#