Home NDC 11788-136 Captopril
Product NDC 11788-136
11-digit product format 117880136
Labeler code 11788
Product ID 11788-136_8e531d13-c832-4fc0-a405-d63050458879
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Captopril
Dosage form TABLET
Route ORAL
Labeler AiPing Pharmaceutical, Inc.
Application ANDA214442
Marketing category ANDA
Marketing start 2026-04-01
Substance CAPTOPRIL
Active strength 25 mg/1
Pharmacologic classes Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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 A214442-001 CAPTOPRIL CAPTOPRIL 12.5MG TABLET / ORAL AB 2023-01-27 A214442-002 CAPTOPRIL CAPTOPRIL 25MG TABLET / ORAL AB 2023-01-27 A214442-003 CAPTOPRIL CAPTOPRIL 50MG TABLET / ORAL AB 2023-01-27 A214442-004 CAPTOPRIL CAPTOPRIL 100MG TABLET / ORAL AB 2023-01-27
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 3 · 92 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 A214442-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 2023-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214442-002 CAPTOPRIL 25MG TABLET / ORAL AB 2023-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214442-003 CAPTOPRIL 50MG TABLET / ORAL AB 2023-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214442-004 CAPTOPRIL 100MG TABLET / ORAL AB 2023-01-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214442-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 2023-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214442-002 CAPTOPRIL 25MG TABLET / ORAL AB 2023-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214442-003 CAPTOPRIL 50MG TABLET / ORAL AB 2023-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214442-004 CAPTOPRIL 100MG TABLET / ORAL AB 2023-01-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214442-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 2023-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214442-002 CAPTOPRIL 25MG TABLET / ORAL AB 2023-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214442-003 CAPTOPRIL 50MG TABLET / ORAL AB 2023-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214442-004 CAPTOPRIL 100MG TABLET / ORAL AB 2023-01-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214442-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 2023-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214442-002 CAPTOPRIL 25MG TABLET / ORAL AB 2023-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214442-003 CAPTOPRIL 50MG TABLET / ORAL AB 2023-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214442-004 CAPTOPRIL 100MG TABLET / ORAL AB 2023-01-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214442-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 2023-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214442-002 CAPTOPRIL 25MG TABLET / ORAL AB 2023-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214442-003 CAPTOPRIL 50MG TABLET / ORAL AB 2023-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214442-004 CAPTOPRIL 100MG TABLET / ORAL AB 2023-01-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214442-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 2023-01-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214442-002 CAPTOPRIL 25MG TABLET / ORAL AB 2023-01-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214442-003 CAPTOPRIL 50MG TABLET / ORAL AB 2023-01-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214442-004 CAPTOPRIL 100MG TABLET / ORAL AB 2023-01-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214442-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 2023-01-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214442-002 CAPTOPRIL 25MG TABLET / ORAL AB 2023-01-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214442-003 CAPTOPRIL 50MG TABLET / ORAL AB 2023-01-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214442-004 CAPTOPRIL 100MG TABLET / ORAL AB 2023-01-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214442-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 2023-01-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214442-002 CAPTOPRIL 25MG TABLET / ORAL AB 2023-01-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214442-003 CAPTOPRIL 50MG TABLET / ORAL AB 2023-01-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214442-004 CAPTOPRIL 100MG TABLET / ORAL AB 2023-01-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214442-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 2023-01-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214442-002 CAPTOPRIL 25MG TABLET / ORAL AB 2023-01-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214442-003 CAPTOPRIL 50MG TABLET / ORAL AB 2023-01-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214442-004 CAPTOPRIL 100MG TABLET / ORAL AB 2023-01-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214442-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 2023-01-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214442-002 CAPTOPRIL 25MG TABLET / ORAL AB 2023-01-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214442-003 CAPTOPRIL 50MG TABLET / ORAL AB 2023-01-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214442-004 CAPTOPRIL 100MG TABLET / ORAL AB 2023-01-27 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 92 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Captopril
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CAPTOPRIL 25 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 11788-136-01 Captopril 100 in 1 BOTTLE TABLET 100 1
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# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 11788-136-01 11788013601 100 TABLET in 1 BOTTLE (11788-136-01) 100 tablet 2026-04-01 No No Current