Home NDC 0904-7106 Captopril
Product NDC 0904-7106
11-digit product format 009047106
Labeler code 0904
Product ID 0904-7106_ca598786-19c6-4d57-8e6f-26eaad0c13c3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Captopril
Dosage form TABLET
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA212809
Marketing category ANDA
Marketing start 2019-12-13
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 A212809-001 CAPTOPRIL CAPTOPRIL 12.5MG TABLET / ORAL AB 2019-12-13 A212809-002 CAPTOPRIL CAPTOPRIL 25MG TABLET / ORAL AB 2019-12-13 A212809-003 CAPTOPRIL CAPTOPRIL 50MG TABLET / ORAL AB 2019-12-13 A212809-004 CAPTOPRIL CAPTOPRIL 100MG TABLET / ORAL AB 2019-12-13
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 4 · 148 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 A212809-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 2019-12-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212809-002 CAPTOPRIL 25MG TABLET / ORAL AB 2019-12-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212809-003 CAPTOPRIL 50MG TABLET / ORAL AB 2019-12-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212809-004 CAPTOPRIL 100MG TABLET / ORAL AB 2019-12-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212809-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 2019-12-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212809-002 CAPTOPRIL 25MG TABLET / ORAL AB 2019-12-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212809-003 CAPTOPRIL 50MG TABLET / ORAL AB 2019-12-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212809-004 CAPTOPRIL 100MG TABLET / ORAL AB 2019-12-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212809-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 2019-12-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212809-002 CAPTOPRIL 25MG TABLET / ORAL AB 2019-12-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212809-003 CAPTOPRIL 50MG TABLET / ORAL AB 2019-12-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212809-004 CAPTOPRIL 100MG TABLET / ORAL AB 2019-12-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212809-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 2019-12-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212809-002 CAPTOPRIL 25MG TABLET / ORAL AB 2019-12-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212809-003 CAPTOPRIL 50MG TABLET / ORAL AB 2019-12-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212809-004 CAPTOPRIL 100MG TABLET / ORAL AB 2019-12-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212809-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 2019-12-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212809-002 CAPTOPRIL 25MG TABLET / ORAL AB 2019-12-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212809-003 CAPTOPRIL 50MG TABLET / ORAL AB 2019-12-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212809-004 CAPTOPRIL 100MG TABLET / ORAL AB 2019-12-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212809-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 2019-12-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212809-002 CAPTOPRIL 25MG TABLET / ORAL AB 2019-12-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212809-003 CAPTOPRIL 50MG TABLET / ORAL AB 2019-12-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212809-004 CAPTOPRIL 100MG TABLET / ORAL AB 2019-12-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212809-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 2019-12-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212809-002 CAPTOPRIL 25MG TABLET / ORAL AB 2019-12-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212809-003 CAPTOPRIL 50MG TABLET / ORAL AB 2019-12-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212809-004 CAPTOPRIL 100MG TABLET / ORAL AB 2019-12-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212809-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 2019-12-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212809-002 CAPTOPRIL 25MG TABLET / ORAL AB 2019-12-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212809-003 CAPTOPRIL 50MG TABLET / ORAL AB 2019-12-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212809-004 CAPTOPRIL 100MG TABLET / ORAL AB 2019-12-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212809-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 2019-12-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212809-002 CAPTOPRIL 25MG TABLET / ORAL AB 2019-12-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212809-003 CAPTOPRIL 50MG TABLET / ORAL AB 2019-12-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212809-004 CAPTOPRIL 100MG TABLET / ORAL AB 2019-12-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212809-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 2019-12-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212809-002 CAPTOPRIL 25MG TABLET / ORAL AB 2019-12-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212809-003 CAPTOPRIL 50MG TABLET / ORAL AB 2019-12-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212809-004 CAPTOPRIL 100MG TABLET / ORAL AB 2019-12-13 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 148 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308963 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 0904-7106-61 Captopril 100 in 1 CARTON TABLET 100 7 0904-7106-61 Captopril 1 in 1 BLISTER PACK TABLET 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-7106 CAPTOPRIL TABLET [MAJOR PHARMACEUTICALS] 3 Current NDC, Legacy NDC, 2 package rows 20241222_a43a5373-ded9-4912-8c98-edaec8352836.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Captopril CAPTOPRIL Bryant Ranch Prepack 563737c5-4d63-4957-8022-e3bc3112dfac 2026-05-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212809 application number: ANDA212809 Captopril CAPTOPRIL Bryant Ranch Prepack 66604c8e-f6b6-4cf9-9561-f1cb4af0e0d6 2026-05-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212809 application number: ANDA212809 Captopril CAPTOPRIL Major Pharmaceuticals a43a5373-ded9-4912-8c98-edaec8352836 2026-05-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212809 application number: ANDA212809 ndc (product): 0904-7106 Captopril CAPTOPRIL Ajanta Pharma USA Inc. 1fbc9b28-ff10-4b17-a359-e12b4330747e 2025-11-27 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212809 application number: ANDA212809
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 0904-7106-61 00904710661 100 BLISTER PACK in 1 CARTON (0904-7106-61) / 1 TABLET in 1 BLISTER PACK 100 blister pack 2019-12-13 0000-00-00 No No Current