Home NDC 63629-8727 Captopril
Product NDC 63629-8727
11-digit product format 636298727
Labeler code 63629
Product ID 63629-8727_4662d7f2-f7fd-4ead-9a7d-8cd1e4f16575
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Captopril
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA074477
Marketing category ANDA
Marketing start 2016-07-01
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 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63629-8727-1 Captopril 100 in 1 BOTTLE TABLET 100 102
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-8727 CAPTOPRIL TABLET [BRYANT RANCH PREPACK] 102 Current NDC, Legacy NDC, 1 package rows 20240112_2baec3fb-e7b0-46b4-a69d-29f6448532bc.zip
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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63629-8727-1 63629872701 100 TABLET in 1 BOTTLE (63629-8727-1) 100 tablet 2021-08-19 0000-00-00 No No Current