Home NDC 0143-1171 Captopril
Product NDC 0143-1171
11-digit product format 001431171
Labeler code 0143
Product ID 0143-1171_dcd9332a-1256-457f-900a-b658c6d619c9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Captopril
Dosage form TABLET
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA074505
Marketing category ANDA
Marketing start 1996-02-13
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 A074505-001 CAPTOPRIL CAPTOPRIL 12.5MG TABLET / ORAL AB 1996-02-13 A074505-002 CAPTOPRIL CAPTOPRIL 25MG TABLET / ORAL AB 1996-02-13 A074505-003 CAPTOPRIL CAPTOPRIL 50MG TABLET / ORAL AB 1996-02-13 A074505-004 CAPTOPRIL CAPTOPRIL 100MG TABLET / ORAL AB RS 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 A074505-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 1996-02-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074505-002 CAPTOPRIL 25MG TABLET / ORAL AB 1996-02-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074505-003 CAPTOPRIL 50MG TABLET / ORAL AB 1996-02-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074505-004 CAPTOPRIL 100MG TABLET / ORAL AB RS 1996-02-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074505-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 1996-02-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074505-002 CAPTOPRIL 25MG TABLET / ORAL AB 1996-02-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074505-003 CAPTOPRIL 50MG TABLET / ORAL AB 1996-02-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074505-004 CAPTOPRIL 100MG TABLET / ORAL AB RS 1996-02-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074505-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 1996-02-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074505-002 CAPTOPRIL 25MG TABLET / ORAL AB 1996-02-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074505-003 CAPTOPRIL 50MG TABLET / ORAL AB 1996-02-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074505-004 CAPTOPRIL 100MG TABLET / ORAL AB RS 1996-02-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074505-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 1996-02-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074505-002 CAPTOPRIL 25MG TABLET / ORAL AB 1996-02-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074505-003 CAPTOPRIL 50MG TABLET / ORAL AB 1996-02-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074505-004 CAPTOPRIL 100MG TABLET / ORAL AB RS 1996-02-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074505-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 1996-02-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074505-002 CAPTOPRIL 25MG TABLET / ORAL AB 1996-02-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074505-003 CAPTOPRIL 50MG TABLET / ORAL AB 1996-02-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074505-004 CAPTOPRIL 100MG TABLET / ORAL AB RS 1996-02-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074505-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 1996-02-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074505-002 CAPTOPRIL 25MG TABLET / ORAL AB 1996-02-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074505-003 CAPTOPRIL 50MG TABLET / ORAL AB 1996-02-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074505-004 CAPTOPRIL 100MG TABLET / ORAL AB RS 1996-02-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074505-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 1996-02-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074505-002 CAPTOPRIL 25MG TABLET / ORAL AB 1996-02-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074505-003 CAPTOPRIL 50MG TABLET / ORAL AB 1996-02-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074505-004 CAPTOPRIL 100MG TABLET / ORAL AB RS 1996-02-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074505-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 1996-02-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074505-002 CAPTOPRIL 25MG TABLET / ORAL AB 1996-02-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074505-003 CAPTOPRIL 50MG TABLET / ORAL AB 1996-02-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074505-004 CAPTOPRIL 100MG TABLET / ORAL AB RS 1996-02-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074505-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 1996-02-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074505-002 CAPTOPRIL 25MG TABLET / ORAL AB 1996-02-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074505-003 CAPTOPRIL 50MG TABLET / ORAL AB 1996-02-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074505-004 CAPTOPRIL 100MG TABLET / ORAL AB RS 1996-02-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074505-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 1996-02-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074505-002 CAPTOPRIL 25MG TABLET / ORAL AB 1996-02-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074505-003 CAPTOPRIL 50MG TABLET / ORAL AB 1996-02-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074505-004 CAPTOPRIL 100MG TABLET / ORAL AB RS 1996-02-13 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 0143-1171-01 Captopril 100 in 1 BOTTLE TABLET 100 29 0143-1171-10 Captopril 1000 in 1 BOTTLE TABLET 1000 29
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CAPTOPRIL ACTIVE INGREDIENT 9G64RSX1XD CAPTOPRIL TABLET [WEST-WARD PHARMACEUTICALS CORP] 12 CAPTOPRIL ACTIVE MOIETY 9G64RSX1XD CAPTOPRIL TABLET [WEST-WARD PHARMACEUTICALS CORP] 12 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK CAPTOPRIL TABLET [WEST-WARD PHARMACEUTICALS CORP] 12 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CAPTOPRIL TABLET [WEST-WARD PHARMACEUTICALS CORP] 12 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CAPTOPRIL TABLET [WEST-WARD PHARMACEUTICALS CORP] 12 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CAPTOPRIL TABLET [WEST-WARD PHARMACEUTICALS CORP] 12 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CAPTOPRIL TABLET [WEST-WARD PHARMACEUTICALS CORP] 12 STARCH, POTATO INACTIVE INGREDIENT 8I089SAH3T CAPTOPRIL TABLET [WEST-WARD PHARMACEUTICALS CORP] 12 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP CAPTOPRIL TABLET [WEST-WARD PHARMACEUTICALS CORP] 12 CAPTOPRIL ACTIVE INGREDIENT 9G64RSX1XD CAPTOPRIL TABLET [PHYSICIANS TOTAL CARE, INC.] 3 CAPTOPRIL ACTIVE MOIETY 9G64RSX1XD CAPTOPRIL TABLET [PHYSICIANS TOTAL CARE, INC.] 3 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK CAPTOPRIL TABLET [PHYSICIANS TOTAL CARE, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CAPTOPRIL TABLET [PHYSICIANS TOTAL CARE, INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CAPTOPRIL TABLET [PHYSICIANS TOTAL CARE, INC.] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CAPTOPRIL TABLET [PHYSICIANS TOTAL CARE, INC.] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CAPTOPRIL TABLET [PHYSICIANS TOTAL CARE, INC.] 3 STARCH, POTATO INACTIVE INGREDIENT 8I089SAH3T CAPTOPRIL TABLET [PHYSICIANS TOTAL CARE, INC.] 3 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP CAPTOPRIL TABLET [PHYSICIANS TOTAL CARE, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-1171 CAPTOPRIL TABLET [HIKMA PHARMACEUTICALS USA INC.] 29 Current NDC, Legacy NDC, 2 package rows 20241228_607687f4-63cf-411c-a20b-21d238a6b7a7.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 Golden State Medical Supply, Inc. d117c8bd-50a8-7355-e053-2a95a90ac70f 2025-11-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074505 application number: ANDA074505 Captopril CAPTOPRIL PD-Rx Pharmaceuticals, Inc. 65ed6e70-f1ee-437e-965c-d1b1fdadd832 2025-03-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074505 application number: ANDA074505 Captopril CAPTOPRIL Hikma Pharmaceuticals USA Inc. 607687f4-63cf-411c-a20b-21d238a6b7a7 2024-12-27 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074505 application number: ANDA074505 ndc (product): 0143-1171 Captopril CAPTOPRIL American Health Packaging 9b54feb0-13cd-46a8-9924-f12880381196 2024-12-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074505 application number: ANDA074505
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 0143-1171-01 00143117101 100 TABLET in 1 BOTTLE (0143-1171-01) 100 tablet 1996-02-13 0000-00-00 No No Current 0143-1171-10 00143117110 1000 TABLET in 1 BOTTLE (0143-1171-10) 1000 tablet 1996-02-13 0000-00-00 No No Current