Home NDC 50268-127 Bisoprolol Fumarate
Product NDC 50268-127
11-digit product format 502680127
Labeler code 50268
Product ID 50268-127_0e85a1ff-1540-187e-e063-6394a90a3b1e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bisoprolol Fumarate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler AvPAK
Application ANDA077910
Marketing category ANDA
Marketing start 2022-01-10
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 A077910-001 BISOPROLOL FUMARATE BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2006-12-27 A077910-002 BISOPROLOL FUMARATE BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2006-12-27
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.
Product history page 1 of 3 · 82 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 2026-02-19 14:30 UTC 2026-02 A077910-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2006-12-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077910-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2006-12-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077910-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2006-12-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077910-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2006-12-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077910-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2006-12-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077910-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2006-12-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077910-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2006-12-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077910-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2006-12-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077910-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2006-12-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077910-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2006-12-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077910-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2006-12-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077910-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2006-12-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077910-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2006-12-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077910-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2006-12-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077910-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2006-12-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077910-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2006-12-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077910-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2006-12-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077910-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2006-12-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077910-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2006-12-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077910-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2006-12-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077910-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2006-12-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077910-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2006-12-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077910-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2006-12-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077910-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2006-12-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077910-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2006-12-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077910-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2006-12-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077910-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2006-12-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077910-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2006-12-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077910-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2006-12-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077910-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2006-12-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077910-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2006-12-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077910-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2006-12-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077910-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2006-12-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077910-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2006-12-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077910-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2006-12-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077910-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2006-12-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077910-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2006-12-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077910-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2006-12-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077910-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2006-12-27 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A077910-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2006-12-27 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 50268-127-11 Bisoprolol Fumarate 1 in 1 BLISTER PACK TABLET, FILM COATED 1 2 50268-127-15 Bisoprolol Fumarate 50 in 1 BOX TABLET, FILM COATED 50 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50268-127 BISOPROLOL FUMARATE TABLET, FILM COATED [AVPAK] 2 Current NDC, Legacy NDC, 2 package rows 20240110_d540ef44-9016-9d66-e053-2a95a90a16a9.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 · 3 matching rows.
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 50268-127-11 50268012711 1 in 1 BLISTER PACK Historical 50268-127-15 50268012715 50 BLISTER PACK in 1 BOX (50268-127-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-127-11) 50 blister pack 2022-01-10 0000-00-00 No No Current