Home NDC 71335-9755 Bisoprolol Fumarate
Product NDC 71335-9755
11-digit product format 713359755
Labeler code 71335
Product ID 71335-9755_55384543-dd64-4b42-830e-a2c82a830f3e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bisoprolol Fumarate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA075643
Marketing category ANDA
Marketing start 2000-11-16
Substance BISOPROLOL FUMARATE
Active strength 10 mg/1
Pharmacologic classes Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
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 1 .
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 A075643-001 BISOPROLOL FUMARATE BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2000-11-16 A075643-002 BISOPROLOL FUMARATE BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2000-11-16 A075643-003 BISOPROLOL FUMARATE BISOPROLOL FUMARATE 2.5MG TABLET / ORAL 2025-03-07
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 · 86 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 A075643-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2000-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075643-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2000-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075643-003 BISOPROLOL FUMARATE 2.5MG TABLET / ORAL 2025-03-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075643-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2000-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075643-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2000-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075643-003 BISOPROLOL FUMARATE 2.5MG TABLET / ORAL 2025-03-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075643-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2000-11-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075643-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2000-11-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075643-003 BISOPROLOL FUMARATE 2.5MG TABLET / ORAL 2025-03-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075643-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2000-11-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075643-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2000-11-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075643-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2000-11-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075643-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2000-11-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075643-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2000-11-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075643-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2000-11-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075643-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2000-11-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075643-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2000-11-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075643-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2000-11-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075643-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2000-11-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075643-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2000-11-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075643-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2000-11-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075643-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2000-11-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075643-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2000-11-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075643-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2000-11-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075643-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2000-11-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075643-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2000-11-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075643-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2000-11-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075643-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2000-11-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075643-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2000-11-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075643-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2000-11-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075643-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2000-11-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075643-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2000-11-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075643-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2000-11-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075643-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2000-11-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075643-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2000-11-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075643-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2000-11-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075643-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2000-11-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075643-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2000-11-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075643-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2000-11-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075643-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2000-11-16 bb7c543d1eb4…
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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BISOPROLOL FUMARATE 10 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 854901 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 71335-9755-1 Bisoprolol Fumarate 30 in 1 BOTTLE TABLET, FILM COATED 30 101 71335-9755-2 Bisoprolol Fumarate 120 in 1 BOTTLE TABLET, FILM COATED 120 101 71335-9755-3 Bisoprolol Fumarate 180 in 1 BOTTLE TABLET, FILM COATED 180 101 71335-9755-4 Bisoprolol Fumarate 90 in 1 BOTTLE TABLET, FILM COATED 90 101
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-9755 BISOPROLOL FUMARATE (BISOPROLOL FUMARATE) TABLET, FILM COATED [BRYANT RANCH PREPACK] 100 Current NDC, 4 package rows 20230726_6ebe6ec0-6223-425c-9f3b-8ab8dd8b3f5f.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 Marketing start Sample Exclude flag Status 71335-9755-1 71335975501 30 TABLET, FILM COATED in 1 BOTTLE (71335-9755-1) 2026-04-09 No No Current 71335-9755-2 71335975502 120 TABLET, FILM COATED in 1 BOTTLE (71335-9755-2) 2026-04-09 No No Current 71335-9755-3 71335975503 180 TABLET, FILM COATED in 1 BOTTLE (71335-9755-3) 2026-04-09 No No Current 71335-9755-4 71335975504 90 TABLET, FILM COATED in 1 BOTTLE (71335-9755-4) 2026-04-09 No No Current