Home NDC 43547-616 Bisoprolol fumarate
Product NDC 43547-616
11-digit product format 435470616
Labeler code 43547
Product ID 43547-616_e8b6cea1-8a7f-4255-8a24-ff96d6ceece2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bisoprolol fumarate
Dosage form TABLET
Route ORAL
Labeler Solco Healthcare US, LLC
Application ANDA217368
Marketing category ANDA
Marketing start 2022-07-05
Substance BISOPROLOL FUMARATE
Active strength 5 mg/1
Pharmacologic classes Adrenergic beta-Antagonists [MoA], 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 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217368-001 BISOPROLOL FUMARATE BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2023-07-14 A217368-002 BISOPROLOL FUMARATE BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2023-07-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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.
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 A217368-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2023-07-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217368-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2023-07-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217368-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2023-07-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217368-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2023-07-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217368-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2023-07-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217368-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2023-07-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217368-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2023-07-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217368-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2023-07-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217368-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2023-07-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217368-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2023-07-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217368-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2023-07-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217368-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2023-07-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217368-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2023-07-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217368-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2023-07-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217368-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2023-07-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217368-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2023-07-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217368-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2023-07-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217368-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2023-07-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217368-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2023-07-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217368-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2023-07-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217368-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2023-07-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217368-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2023-07-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217368-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2023-07-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217368-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2023-07-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217368-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2023-07-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217368-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2023-07-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217368-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2023-07-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A217368-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2023-07-14 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217368-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2023-07-14 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217368-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2023-07-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217368-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2023-07-14 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A217368-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2023-07-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217368-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2023-07-14 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A217368-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2023-07-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217368-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2023-07-14 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217368-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2023-07-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217368-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2023-07-14 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217368-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2023-07-14 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217368-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2023-07-14 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217368-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2023-07-14 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Bisoprolol fumarate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BISOPROLOL FUMARATE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination UR59KN573L Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 854901 Internal RxNorm lookup 854905 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 43547-616-03 Bisoprolol fumarate 30 in 1 BOTTLE TABLET 30 3 43547-616-10 Bisoprolol fumarate 100 in 1 BOTTLE TABLET 100 3 43547-616-50 Bisoprolol fumarate 500 in 1 BOTTLE TABLET 500 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43547-616 BISOPROLOL FUMARATE TABLET [SOLCO HEALTHCARE US, LLC] 3 Current NDC, 3 package rows 20250502_084308e4-3b8b-40d6-acbf-d775772a8a73.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 43547-616-03 43547061603 30 TABLET in 1 BOTTLE (43547-616-03) 30 tablet 2022-07-05 No No Current 43547-616-10 43547061610 100 TABLET in 1 BOTTLE (43547-616-10) 100 tablet 2022-07-05 No No Current 43547-616-50 43547061650 500 TABLET in 1 BOTTLE (43547-616-50) 500 tablet 2022-07-05 No No Current