Home NDC 55289-344 Captopril
Product NDC 55289-344
11-digit product format 552890344
Labeler code 55289
Product ID 55289-344_30c7bba4-3080-305f-e063-6394a90aea6e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Captopril
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA074505
Marketing category ANDA
Marketing start 1996-02-13
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 168 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 2026-08-18 06:07:40 2026-07 A074505-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 1996-02-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074505-002 CAPTOPRIL 25MG TABLET / ORAL AB 1996-02-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074505-003 CAPTOPRIL 50MG TABLET / ORAL AB 1996-02-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074505-004 CAPTOPRIL 100MG TABLET / ORAL AB RS 1996-02-13 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 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 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 55289-344-30 Captopril 30 in 1 BOTTLE, PLASTIC TABLET 30 29 55289-344-90 Captopril 90 in 1 BOTTLE, PLASTIC TABLET 90 29
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CAPTOPRIL ACTIVE INGREDIENT 9G64RSX1XD CAPTOPRIL TABLET [PD-RX PHARMACEUTICALS, INC.] 2 CAPTOPRIL ACTIVE MOIETY 9G64RSX1XD CAPTOPRIL TABLET [PD-RX PHARMACEUTICALS, INC.] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK CAPTOPRIL TABLET [PD-RX PHARMACEUTICALS, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CAPTOPRIL TABLET [PD-RX PHARMACEUTICALS, INC.] 2 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CAPTOPRIL TABLET [PD-RX PHARMACEUTICALS, INC.] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CAPTOPRIL TABLET [PD-RX PHARMACEUTICALS, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CAPTOPRIL TABLET [PD-RX PHARMACEUTICALS, INC.] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP CAPTOPRIL TABLET [PD-RX PHARMACEUTICALS, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55289-344 CAPTOPRIL TABLET [PD-RX PHARMACEUTICALS, INC.] 29 Current NDC, Legacy NDC, 2 package rows 20250322_65ed6e70-f1ee-437e-965c-d1b1fdadd832.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 ndc (product): 55289-344 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 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 55289-344-30 55289034430 30 TABLET in 1 BOTTLE, PLASTIC (55289-344-30) 30 tablet 2011-08-02 0000-00-00 No No Current 55289-344-90 55289034490 90 TABLET in 1 BOTTLE, PLASTIC (55289-344-90) 90 tablet 2011-08-02 0000-00-00 No No Current