Home NDC 50090-6478 bisoprolol fumarate and hydrochlorothiazide
Product NDC 50090-6478
11-digit product format 500906478
Labeler code 50090
Product ID 50090-6478_e4a9e83b-5cbd-4c4e-9fd5-2b02607e6e75
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bisoprolol fumarate and hydrochlorothiazide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler A-S Medication Solutions
Application NDA020186
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2019-08-07
Substance BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
Active strength 2.5; 6.25 mg/1; mg/1
Pharmacologic classes Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]
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 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020186-001 ZIAC BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB RLD 1993-03-26 N020186-002 ZIAC BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 10MG;6.25MG TABLET / ORAL AB RLD, RS 1993-03-26 N020186-003 ZIAC BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 2.5MG;6.25MG TABLET / ORAL AB RLD 1993-03-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 · 129 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 2026-09-14 22:38:34 2026-08 N020186-001 ZIAC 5MG;6.25MG TABLET / ORAL AB RLD 1993-03-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020186-002 ZIAC 10MG;6.25MG TABLET / ORAL AB RLD, RS 1993-03-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020186-003 ZIAC 2.5MG;6.25MG TABLET / ORAL AB RLD 1993-03-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020186-001 ZIAC 5MG;6.25MG TABLET / ORAL AB RLD 1993-03-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020186-002 ZIAC 10MG;6.25MG TABLET / ORAL AB RLD, RS 1993-03-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020186-003 ZIAC 2.5MG;6.25MG TABLET / ORAL AB RLD 1993-03-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020186-001 ZIAC 5MG;6.25MG TABLET / ORAL AB RLD 1993-03-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020186-002 ZIAC 10MG;6.25MG TABLET / ORAL AB RLD, RS 1993-03-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020186-003 ZIAC 2.5MG;6.25MG TABLET / ORAL AB RLD 1993-03-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020186-001 ZIAC 5MG;6.25MG TABLET / ORAL AB RLD 1993-03-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020186-002 ZIAC 10MG;6.25MG TABLET / ORAL AB RLD, RS 1993-03-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020186-003 ZIAC 2.5MG;6.25MG TABLET / ORAL AB RLD 1993-03-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020186-001 ZIAC 5MG;6.25MG TABLET / ORAL AB RLD 1993-03-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020186-002 ZIAC 10MG;6.25MG TABLET / ORAL AB RLD, RS 1993-03-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020186-003 ZIAC 2.5MG;6.25MG TABLET / ORAL AB RLD 1993-03-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020186-001 ZIAC 5MG;6.25MG TABLET / ORAL AB RLD 1993-03-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020186-002 ZIAC 10MG;6.25MG TABLET / ORAL AB RLD, RS 1993-03-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020186-003 ZIAC 2.5MG;6.25MG TABLET / ORAL AB RLD 1993-03-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020186-001 ZIAC 5MG;6.25MG TABLET / ORAL AB RLD 1993-03-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020186-002 ZIAC 10MG;6.25MG TABLET / ORAL AB RLD, RS 1993-03-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020186-003 ZIAC 2.5MG;6.25MG TABLET / ORAL AB RLD 1993-03-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020186-001 ZIAC 5MG;6.25MG TABLET / ORAL AB RLD 1993-03-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020186-002 ZIAC 10MG;6.25MG TABLET / ORAL AB RLD, RS 1993-03-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020186-003 ZIAC 2.5MG;6.25MG TABLET / ORAL AB RLD 1993-03-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020186-001 ZIAC 5MG;6.25MG TABLET / ORAL AB RLD 1993-03-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020186-002 ZIAC 10MG;6.25MG TABLET / ORAL AB RLD, RS 1993-03-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020186-003 ZIAC 2.5MG;6.25MG TABLET / ORAL AB RLD 1993-03-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020186-001 ZIAC 5MG;6.25MG TABLET / ORAL AB RLD 1993-03-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020186-002 ZIAC 10MG;6.25MG TABLET / ORAL AB RLD, RS 1993-03-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020186-003 ZIAC 2.5MG;6.25MG TABLET / ORAL AB RLD 1993-03-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020186-001 ZIAC 5MG;6.25MG TABLET / ORAL AB RLD 1993-03-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020186-002 ZIAC 10MG;6.25MG TABLET / ORAL AB RLD, RS 1993-03-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020186-003 ZIAC 2.5MG;6.25MG TABLET / ORAL AB RLD 1993-03-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020186-001 ZIAC 5MG;6.25MG TABLET / ORAL AB RLD 1993-03-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020186-002 ZIAC 10MG;6.25MG TABLET / ORAL AB RLD, RS 1993-03-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020186-003 ZIAC 2.5MG;6.25MG TABLET / ORAL AB RLD 1993-03-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020186-001 ZIAC 5MG;6.25MG TABLET / ORAL AB RLD 1993-03-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020186-002 ZIAC 10MG;6.25MG TABLET / ORAL AB RLD, RS 1993-03-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020186-003 ZIAC 2.5MG;6.25MG TABLET / ORAL AB RLD 1993-03-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020186-001 ZIAC 5MG;6.25MG TABLET / ORAL AB RLD 1993-03-26 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
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 bisoprolol fumarate and hydrochlorothiazide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BISOPROLOL FUMARATE 2.5 mg/1 HYDROCHLOROTHIAZIDE 6.25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination UR59KN573L Internal UNII lookup 0J48LPH2TH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 854916 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 50090-6478-0 bisoprolol fumarate and hydrochlorothiazide 30 in 1 BOTTLE TABLET, FILM COATED 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-6478 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] 1 Current NDC, 1 package rows 20230524_cf088009-203e-4d70-b56e-b4062cf3fcd8.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 50090-6478-0 50090647800 30 TABLET, FILM COATED in 1 BOTTLE (50090-6478-0) 2023-05-16 No No Current