Home Applications 074477 Application 074477
Type ANDA
Sponsor PRINSTON INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CAPTOPRIL CAPTOPRIL TABLET;ORAL 12.5MG No No 002 CAPTOPRIL CAPTOPRIL TABLET;ORAL 25MG No No 003 CAPTOPRIL CAPTOPRIL TABLET;ORAL 50MG No No 004 CAPTOPRIL CAPTOPRIL TABLET;ORAL 100MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074477-001 CAPTOPRIL CAPTOPRIL 12.5MG TABLET / ORAL AB 1996-02-13 A074477-002 CAPTOPRIL CAPTOPRIL 25MG TABLET / ORAL AB 1996-02-13 A074477-003 CAPTOPRIL CAPTOPRIL 50MG TABLET / ORAL AB 1996-02-13 A074477-004 CAPTOPRIL CAPTOPRIL 100MG TABLET / ORAL AB 1996-02-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 5 · 164 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 A074477-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 1996-02-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074477-002 CAPTOPRIL 25MG TABLET / ORAL AB 1996-02-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074477-003 CAPTOPRIL 50MG TABLET / ORAL AB 1996-02-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074477-004 CAPTOPRIL 100MG TABLET / ORAL AB 1996-02-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074477-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 1996-02-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074477-002 CAPTOPRIL 25MG TABLET / ORAL AB 1996-02-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074477-003 CAPTOPRIL 50MG TABLET / ORAL AB 1996-02-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074477-004 CAPTOPRIL 100MG TABLET / ORAL AB 1996-02-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074477-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 1996-02-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074477-002 CAPTOPRIL 25MG TABLET / ORAL AB 1996-02-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074477-003 CAPTOPRIL 50MG TABLET / ORAL AB 1996-02-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074477-004 CAPTOPRIL 100MG TABLET / ORAL AB 1996-02-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074477-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 1996-02-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074477-002 CAPTOPRIL 25MG TABLET / ORAL AB 1996-02-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074477-003 CAPTOPRIL 50MG TABLET / ORAL AB 1996-02-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074477-004 CAPTOPRIL 100MG TABLET / ORAL AB 1996-02-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074477-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 1996-02-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074477-002 CAPTOPRIL 25MG TABLET / ORAL AB 1996-02-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074477-003 CAPTOPRIL 50MG TABLET / ORAL AB 1996-02-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074477-004 CAPTOPRIL 100MG TABLET / ORAL AB 1996-02-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074477-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 1996-02-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074477-002 CAPTOPRIL 25MG TABLET / ORAL AB 1996-02-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074477-003 CAPTOPRIL 50MG TABLET / ORAL AB 1996-02-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074477-004 CAPTOPRIL 100MG TABLET / ORAL AB 1996-02-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074477-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 1996-02-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074477-002 CAPTOPRIL 25MG TABLET / ORAL AB 1996-02-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074477-003 CAPTOPRIL 50MG TABLET / ORAL AB 1996-02-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074477-004 CAPTOPRIL 100MG TABLET / ORAL AB 1996-02-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074477-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 1996-02-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074477-002 CAPTOPRIL 25MG TABLET / ORAL AB 1996-02-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074477-003 CAPTOPRIL 50MG TABLET / ORAL AB 1996-02-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074477-004 CAPTOPRIL 100MG TABLET / ORAL AB 1996-02-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074477-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 1996-02-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074477-002 CAPTOPRIL 25MG TABLET / ORAL AB 1996-02-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074477-003 CAPTOPRIL 50MG TABLET / ORAL AB 1996-02-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074477-004 CAPTOPRIL 100MG TABLET / ORAL AB 1996-02-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074477-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 1996-02-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074477-002 CAPTOPRIL 25MG TABLET / ORAL AB 1996-02-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074477-003 CAPTOPRIL 50MG TABLET / ORAL AB 1996-02-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074477-004 CAPTOPRIL 100MG TABLET / ORAL AB 1996-02-13 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Captopril CAPTOPRIL Solco Healthcare US, LLC 2d3779b0-83d9-4b6f-a043-f7768cd7fce6 2025-12-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074477 application number: ANDA074477
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 21 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0781-8052 Captopril Captopril SANDOZ INC. ANDA Current 0781-8052 Captopril Captopril SANDOZ INC. ANDA Current 0781-8061 Captopril Captopril SANDOZ INC. ANDA Current 0781-8061 Captopril Captopril SANDOZ INC. ANDA Current 0781-8075 Captopril Captopril SANDOZ INC. ANDA Current 0781-8075 Captopril Captopril SANDOZ INC. ANDA Current 0781-8080 Captopril Captopril SANDOZ INC. ANDA Current 0781-8080 Captopril Captopril SANDOZ INC. ANDA Current 50090-4296 Captopril Captopril A-S Medication Solutions ANDA Current 50090-4296 Captopril Captopril A-S Medication Solutions ANDA Current 63629-8727 Captopril Captopril Bryant Ranch Prepack ANDA Current 63629-8727 Captopril Captopril Bryant Ranch Prepack ANDA Current 63629-8728 Captopril Captopril Bryant Ranch Prepack ANDA Current 63629-8728 Captopril Captopril Bryant Ranch Prepack ANDA Current 63629-8729 Captopril Captopril Bryant Ranch Prepack ANDA Current 63629-8729 Captopril Captopril Bryant Ranch Prepack ANDA Current 63629-8730 Captopril Captopril Bryant Ranch Prepack ANDA Current 63629-8730 Captopril Captopril Bryant Ranch Prepack ANDA Current 71335-0826 Captopril Captopril Bryant Ranch Prepack ANDA Current 71335-0826 Captopril Captopril Bryant Ranch Prepack ANDA Current 71335-0826 Captopril Captopril Bryant Ranch Prepack ANDA Current