Home NDC 50090-5905 Bisoprolol Fumarate and Hydrochlorothiazide
Product NDC 50090-5905
11-digit product format 500905905
Labeler code 50090
Product ID 50090-5905_fe02e259-324e-4cee-9151-6c4711e2b507
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bisoprolol Fumarate and Hydrochlorothiazide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler A-S Medication Solutions
Application ANDA212678
Marketing category ANDA
Marketing start 2019-04-30
Substance BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
Active strength 10; 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 28 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50090-5905-0 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50090-5905-0 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50090-5905-0 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50090-5905-0 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50090-5905-0 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50090-5905-0 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50090-5905-0 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50090-5905-0 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50090-5905-0 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50090-5905-0 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50090-5905-0 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 50090-5905-0 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 50090-5905-0 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 50090-5905-0 1332a3947898…d4bfe170f9cd…
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 A212678-001 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 2.5MG;6.25MG TABLET / ORAL AB 2020-07-09 A212678-002 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2020-07-09 A212678-003 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 10MG;6.25MG TABLET / ORAL AB 2020-07-09
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 3 · 117 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 A212678-001 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 2.5MG;6.25MG TABLET / ORAL AB 2020-07-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A212678-002 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2020-07-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A212678-003 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 10MG;6.25MG TABLET / ORAL AB 2020-07-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A212678-001 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 2.5MG;6.25MG TABLET / ORAL AB 2020-07-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212678-002 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2020-07-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212678-003 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 10MG;6.25MG TABLET / ORAL AB 2020-07-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212678-001 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 2.5MG;6.25MG TABLET / ORAL AB 2020-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212678-002 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2020-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212678-003 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 10MG;6.25MG TABLET / ORAL AB 2020-07-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212678-001 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 2.5MG;6.25MG TABLET / ORAL AB 2020-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212678-002 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2020-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212678-003 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 10MG;6.25MG TABLET / ORAL AB 2020-07-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212678-001 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 2.5MG;6.25MG TABLET / ORAL AB 2020-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212678-002 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2020-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212678-003 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 10MG;6.25MG TABLET / ORAL AB 2020-07-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212678-001 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 2.5MG;6.25MG TABLET / ORAL AB 2020-07-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212678-002 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2020-07-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212678-003 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 10MG;6.25MG TABLET / ORAL AB 2020-07-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212678-001 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 2.5MG;6.25MG TABLET / ORAL AB 2020-07-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212678-002 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2020-07-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212678-003 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 10MG;6.25MG TABLET / ORAL AB 2020-07-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212678-001 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 2.5MG;6.25MG TABLET / ORAL AB 2020-07-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212678-002 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2020-07-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212678-003 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 10MG;6.25MG TABLET / ORAL AB 2020-07-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212678-001 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 2.5MG;6.25MG TABLET / ORAL AB 2020-07-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212678-002 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2020-07-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212678-003 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 10MG;6.25MG TABLET / ORAL AB 2020-07-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212678-001 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 2.5MG;6.25MG TABLET / ORAL AB 2020-07-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212678-002 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2020-07-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212678-003 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 10MG;6.25MG TABLET / ORAL AB 2020-07-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212678-001 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 2.5MG;6.25MG TABLET / ORAL AB 2020-07-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212678-002 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2020-07-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212678-003 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 10MG;6.25MG TABLET / ORAL AB 2020-07-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212678-001 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 2.5MG;6.25MG TABLET / ORAL AB 2020-07-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212678-002 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2020-07-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212678-003 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 10MG;6.25MG TABLET / ORAL AB 2020-07-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212678-001 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 2.5MG;6.25MG TABLET / ORAL AB 2020-07-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212678-002 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2020-07-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212678-003 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 10MG;6.25MG TABLET / ORAL AB 2020-07-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212678-001 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 2.5MG;6.25MG TABLET / ORAL AB 2020-07-09 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 117 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 10 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 854908 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-5905-0 Bisoprolol Fumarate and Hydrochlorothiazide 30 in 1 BOTTLE TABLET, FILM COATED 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-5905 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] 1 Current NDC, Legacy NDC, 1 package rows 20220121_6b7f96c3-daf4-4029-a96b-baa37add0edb.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 · 5 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50090-5905-0 50090590500 30 TABLET, FILM COATED in 1 BOTTLE (50090-5905-0) 2022-01-17 0000-00-00 No No Current