Home NDC 58657-935 captopril
Product NDC 58657-935
11-digit product format 586570935
Labeler code 58657
Product ID 58657-935_457502be-feb2-5e2f-e063-6394a90aec0b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name captopril
Dosage form TABLET
Route ORAL
Labeler Method Pharmaceuticals LLC
Application ANDA074677
Marketing category ANDA
Marketing start 2025-12-01
Substance CAPTOPRIL
Active strength 12.5 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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074677-001 CAPTOPRIL CAPTOPRIL 50MG TABLET / ORAL AB 1997-05-30 A074677-002 CAPTOPRIL CAPTOPRIL 25MG TABLET / ORAL AB 1997-05-30 A074677-003 CAPTOPRIL CAPTOPRIL 100MG TABLET / ORAL AB 1997-05-30 A074677-004 CAPTOPRIL CAPTOPRIL 12.5MG TABLET / ORAL AB 1997-05-30
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 A074677-001 CAPTOPRIL 50MG TABLET / ORAL AB 1997-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074677-002 CAPTOPRIL 25MG TABLET / ORAL AB 1997-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074677-003 CAPTOPRIL 100MG TABLET / ORAL AB 1997-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074677-004 CAPTOPRIL 12.5MG TABLET / ORAL AB 1997-05-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074677-001 CAPTOPRIL 50MG TABLET / ORAL AB 1997-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074677-002 CAPTOPRIL 25MG TABLET / ORAL AB 1997-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074677-003 CAPTOPRIL 100MG TABLET / ORAL AB 1997-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074677-004 CAPTOPRIL 12.5MG TABLET / ORAL AB 1997-05-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074677-001 CAPTOPRIL 50MG TABLET / ORAL AB 1997-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074677-002 CAPTOPRIL 25MG TABLET / ORAL AB 1997-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074677-003 CAPTOPRIL 100MG TABLET / ORAL AB 1997-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074677-004 CAPTOPRIL 12.5MG TABLET / ORAL AB 1997-05-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074677-001 CAPTOPRIL 50MG TABLET / ORAL AB 1997-05-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074677-002 CAPTOPRIL 25MG TABLET / ORAL AB 1997-05-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074677-003 CAPTOPRIL 100MG TABLET / ORAL AB 1997-05-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074677-004 CAPTOPRIL 12.5MG TABLET / ORAL AB 1997-05-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074677-001 CAPTOPRIL 50MG TABLET / ORAL AB 1997-05-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074677-002 CAPTOPRIL 25MG TABLET / ORAL AB 1997-05-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074677-003 CAPTOPRIL 100MG TABLET / ORAL AB 1997-05-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074677-004 CAPTOPRIL 12.5MG TABLET / ORAL AB 1997-05-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074677-001 CAPTOPRIL 50MG TABLET / ORAL AB 1997-05-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074677-002 CAPTOPRIL 25MG TABLET / ORAL AB 1997-05-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074677-003 CAPTOPRIL 100MG TABLET / ORAL AB 1997-05-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074677-004 CAPTOPRIL 12.5MG TABLET / ORAL AB 1997-05-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074677-001 CAPTOPRIL 50MG TABLET / ORAL AB 1997-05-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074677-002 CAPTOPRIL 25MG TABLET / ORAL AB 1997-05-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074677-003 CAPTOPRIL 100MG TABLET / ORAL AB 1997-05-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074677-004 CAPTOPRIL 12.5MG TABLET / ORAL AB 1997-05-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074677-001 CAPTOPRIL 50MG TABLET / ORAL AB 1997-05-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074677-002 CAPTOPRIL 25MG TABLET / ORAL AB 1997-05-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074677-003 CAPTOPRIL 100MG TABLET / ORAL AB 1997-05-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074677-004 CAPTOPRIL 12.5MG TABLET / ORAL AB 1997-05-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074677-001 CAPTOPRIL 50MG TABLET / ORAL AB 1997-05-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074677-002 CAPTOPRIL 25MG TABLET / ORAL AB 1997-05-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074677-003 CAPTOPRIL 100MG TABLET / ORAL AB 1997-05-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074677-004 CAPTOPRIL 12.5MG TABLET / ORAL AB 1997-05-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074677-001 CAPTOPRIL 50MG TABLET / ORAL AB 1997-05-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074677-002 CAPTOPRIL 25MG TABLET / ORAL AB 1997-05-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074677-003 CAPTOPRIL 100MG TABLET / ORAL AB 1997-05-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074677-004 CAPTOPRIL 12.5MG TABLET / ORAL AB 1997-05-30 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
Additional Listing Data#
Finished product Yes
Brand name base captopril
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CAPTOPRIL 12.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9G64RSX1XD Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308962 Internal RxNorm lookup 308963 Internal RxNorm lookup 308964 Internal RxNorm lookup 317173 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 58657-935-01 captopril 100 in 1 CARTON TABLET 100 3 58657-935-03 captopril 30 in 1 CARTON TABLET 30 3 58657-935-10 captopril 1 in 1 BLISTER PACK TABLET 1 3
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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 58657-935-01 58657093501 100 BLISTER PACK in 1 CARTON (58657-935-01) / 1 TABLET in 1 BLISTER PACK (58657-935-10) 100 blister pack 2025-12-01 No No Current 58657-935-03 58657093503 30 BLISTER PACK in 1 CARTON (58657-935-03) / 1 TABLET in 1 BLISTER PACK (58657-935-10) 30 blister pack 2025-12-01 No No Current 58657-935-10 58657093510 1 in 1 BLISTER PACK Historical