Home NDC 57721-905-01 CAPTOPRIL
Product NDC 57721-905
Requested package NDC 57721-905-01
11-digit product format 577210905
Labeler code 57721
Product ID 57721-905_b7be9918-a633-44d4-8965-d19bab8b83dc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name captopril
Dosage form TABLET
Route ORAL
Labeler Windlas Biotech Limited
Application ANDA074532
Marketing category ANDA
Marketing start 1997-03-28
Marketing end 0000-00-00
Substance CAPTOPRIL
Active strength 100 mg/1
Pharmacologic classes Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
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 · 16 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2019-12-08 06:16 UTC · source 2019-12-05 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 A074532-001 CAPTOPRIL CAPTOPRIL 12.5MG TABLET / ORAL AB 1997-03-28 A074532-002 CAPTOPRIL CAPTOPRIL 25MG TABLET / ORAL AB 1997-03-28 A074532-003 CAPTOPRIL CAPTOPRIL 50MG TABLET / ORAL AB 1997-03-28 A074532-004 CAPTOPRIL CAPTOPRIL 100MG TABLET / ORAL AB 1997-03-28
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 A074532-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 1997-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074532-002 CAPTOPRIL 25MG TABLET / ORAL AB 1997-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074532-003 CAPTOPRIL 50MG TABLET / ORAL AB 1997-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074532-004 CAPTOPRIL 100MG TABLET / ORAL AB 1997-03-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074532-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 1997-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074532-002 CAPTOPRIL 25MG TABLET / ORAL AB 1997-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074532-003 CAPTOPRIL 50MG TABLET / ORAL AB 1997-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074532-004 CAPTOPRIL 100MG TABLET / ORAL AB 1997-03-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074532-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 1997-03-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074532-002 CAPTOPRIL 25MG TABLET / ORAL AB 1997-03-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074532-003 CAPTOPRIL 50MG TABLET / ORAL AB 1997-03-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074532-004 CAPTOPRIL 100MG TABLET / ORAL AB 1997-03-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074532-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 1997-03-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074532-002 CAPTOPRIL 25MG TABLET / ORAL AB 1997-03-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074532-003 CAPTOPRIL 50MG TABLET / ORAL AB 1997-03-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074532-004 CAPTOPRIL 100MG TABLET / ORAL AB 1997-03-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074532-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 1997-03-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074532-002 CAPTOPRIL 25MG TABLET / ORAL AB 1997-03-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074532-003 CAPTOPRIL 50MG TABLET / ORAL AB 1997-03-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074532-004 CAPTOPRIL 100MG TABLET / ORAL AB 1997-03-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074532-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 1997-03-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074532-002 CAPTOPRIL 25MG TABLET / ORAL AB 1997-03-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074532-003 CAPTOPRIL 50MG TABLET / ORAL AB 1997-03-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074532-004 CAPTOPRIL 100MG TABLET / ORAL AB 1997-03-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074532-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 1997-03-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074532-002 CAPTOPRIL 25MG TABLET / ORAL AB 1997-03-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074532-003 CAPTOPRIL 50MG TABLET / ORAL AB 1997-03-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074532-004 CAPTOPRIL 100MG TABLET / ORAL AB 1997-03-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074532-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 1997-03-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074532-002 CAPTOPRIL 25MG TABLET / ORAL AB 1997-03-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074532-003 CAPTOPRIL 50MG TABLET / ORAL AB 1997-03-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074532-004 CAPTOPRIL 100MG TABLET / ORAL AB 1997-03-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074532-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 1997-03-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074532-002 CAPTOPRIL 25MG TABLET / ORAL AB 1997-03-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074532-003 CAPTOPRIL 50MG TABLET / ORAL AB 1997-03-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074532-004 CAPTOPRIL 100MG TABLET / ORAL AB 1997-03-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074532-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 1997-03-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074532-002 CAPTOPRIL 25MG TABLET / ORAL AB 1997-03-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074532-003 CAPTOPRIL 50MG TABLET / ORAL AB 1997-03-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074532-004 CAPTOPRIL 100MG TABLET / ORAL AB 1997-03-28 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57721-905-01 CAPTOPRIL 100 in 1 BOTTLE TABLET 100 3 57721-905-04 CAPTOPRIL 4000 in 1 POUCH TABLET 4000 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57721-905 CAPTOPRIL TABLET [WINDLAS BIOTECH LIMITED] 3 Legacy NDC, 2 package rows 20210715_2f87bcd5-6fc8-4084-9644-519fa5ee8a6b.zip
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 57721-905-01 57721090501 100 TABLET in 1 BOTTLE (57721-905-01) 100 tablet 1997-03-28 0000-00-00 No No Current