Home NDC 16571-830 CAPTOPRIL AND HYDROCHLOROTHIAZIDE
Product NDC 16571-830
11-digit product format 165710830
Labeler code 16571
Product ID 16571-830_0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CAPTOPRIL AND HYDROCHLOROTHIAZIDE
Dosage form TABLET
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA074896
Marketing category ANDA
Marketing start 2023-02-14
Substance CAPTOPRIL; HYDROCHLOROTHIAZIDE
Active strength 50; 25 mg/1; mg/1
Pharmacologic classes Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
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 44 .
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 A074896-001 CAPTOPRIL AND HYDROCHLOROTHIAZIDE CAPTOPRIL; HYDROCHLOROTHIAZIDE 25MG;15MG TABLET / ORAL 1997-12-29 A074896-002 CAPTOPRIL AND HYDROCHLOROTHIAZIDE CAPTOPRIL; HYDROCHLOROTHIAZIDE 25MG;25MG TABLET / ORAL RS 1997-12-29 A074896-003 CAPTOPRIL AND HYDROCHLOROTHIAZIDE CAPTOPRIL; HYDROCHLOROTHIAZIDE 50MG;25MG TABLET / ORAL 1997-12-29 A074896-004 CAPTOPRIL AND HYDROCHLOROTHIAZIDE CAPTOPRIL; HYDROCHLOROTHIAZIDE 50MG;15MG TABLET / ORAL RS 1997-12-29
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 · 176 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 2026-10-15 13:18:30 2026-09 A074896-001 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;15MG TABLET / ORAL 1997-12-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 A074896-002 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;25MG TABLET / ORAL RS 1997-12-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 A074896-003 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;25MG TABLET / ORAL 1997-12-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 A074896-004 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;15MG TABLET / ORAL RS 1997-12-29 c2088c7a36db…2026-09-14 22:38:34 2026-08 A074896-001 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;15MG TABLET / ORAL 1997-12-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A074896-002 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;25MG TABLET / ORAL RS 1997-12-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A074896-003 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;25MG TABLET / ORAL 1997-12-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A074896-004 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;15MG TABLET / ORAL RS 1997-12-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A074896-001 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;15MG TABLET / ORAL 1997-12-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074896-002 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;25MG TABLET / ORAL RS 1997-12-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074896-003 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;25MG TABLET / ORAL 1997-12-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074896-004 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;15MG TABLET / ORAL RS 1997-12-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074896-001 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;15MG TABLET / ORAL 1997-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074896-002 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;25MG TABLET / ORAL RS 1997-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074896-003 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;25MG TABLET / ORAL 1997-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074896-004 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;15MG TABLET / ORAL RS 1997-12-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074896-001 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;15MG TABLET / ORAL 1997-12-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074896-002 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;25MG TABLET / ORAL RS 1997-12-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074896-003 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;25MG TABLET / ORAL 1997-12-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074896-004 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;15MG TABLET / ORAL RS 1997-12-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074896-001 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;15MG TABLET / ORAL 1997-12-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074896-002 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;25MG TABLET / ORAL RS 1997-12-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074896-003 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;25MG TABLET / ORAL 1997-12-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074896-004 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;15MG TABLET / ORAL RS 1997-12-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074896-001 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;15MG TABLET / ORAL 1997-12-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074896-002 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;25MG TABLET / ORAL RS 1997-12-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074896-003 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;25MG TABLET / ORAL 1997-12-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074896-004 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;15MG TABLET / ORAL RS 1997-12-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074896-001 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;15MG TABLET / ORAL 1997-12-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074896-002 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;25MG TABLET / ORAL RS 1997-12-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074896-003 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;25MG TABLET / ORAL 1997-12-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074896-004 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;15MG TABLET / ORAL RS 1997-12-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074896-001 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;15MG TABLET / ORAL 1997-12-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074896-002 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;25MG TABLET / ORAL RS 1997-12-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074896-003 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;25MG TABLET / ORAL 1997-12-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074896-004 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;15MG TABLET / ORAL RS 1997-12-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074896-001 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;15MG TABLET / ORAL 1997-12-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074896-002 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;25MG TABLET / ORAL RS 1997-12-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074896-003 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;25MG TABLET / ORAL 1997-12-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074896-004 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;15MG TABLET / ORAL RS 1997-12-29 2680178bc6a6…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base CAPTOPRIL AND HYDROCHLOROTHIAZIDE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CAPTOPRIL 50 mg/1 HYDROCHLOROTHIAZIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0J48LPH2TH Internal UNII lookup 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 197436 Internal RxNorm lookup 197437 Internal RxNorm lookup 197438 Internal RxNorm lookup 197439 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 16571-830-09 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 90 in 1 BOTTLE TABLET 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16571-830 CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [RISING PHARMA HOLDINGS, INC.] 1 Current NDC, 1 package rows 20230225_0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e.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 · 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 16571-830-09 16571083009 90 TABLET in 1 BOTTLE (16571-830-09) 90 tablet 2023-02-14 No No Current