Home NDC 72888-093 Bisoprolol Fumarate
Product NDC 72888-093
11-digit product format 728880093
Labeler code 72888
Product ID 72888-093_43603823-594f-cbe7-e063-6294a90a9153
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bisoprolol Fumarate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Advagen Pharma Ltd
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 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 · 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 2026-12-31 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 854901 Internal RxNorm lookup 854905 Internal RxNorm lookup 865155 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 72888-093-00 Bisoprolol Fumarate 1000 in 1 BOTTLE TABLET, FILM COATED 1000 3 72888-093-01 Bisoprolol Fumarate 100 in 1 BOTTLE TABLET, FILM COATED 100 3 72888-093-05 Bisoprolol Fumarate 500 in 1 BOTTLE TABLET, FILM COATED 500 3 72888-093-30 Bisoprolol Fumarate 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 72888-093 BISOPROLOL FUMARATE (BISOPROLOL FUMARATE) TABLET, FILM COATED [ADVAGEN PHARMA LTD] 1 Current NDC, Legacy NDC, 4 package rows 20221012_83e4b4e5-9130-44c8-abab-fcd0db5d8c49.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 Marketing end Sample Exclude flag Status 72888-093-00 72888009300 1000 TABLET, FILM COATED in 1 BOTTLE (72888-093-00) 2022-07-01 0000-00-00 No No Current 72888-093-01 72888009301 100 TABLET, FILM COATED in 1 BOTTLE (72888-093-01) 2022-07-01 0000-00-00 No No Current 72888-093-05 72888009305 500 TABLET, FILM COATED in 1 BOTTLE (72888-093-05) 2022-07-01 0000-00-00 No No Current 72888-093-30 72888009330 30 TABLET, FILM COATED in 1 BOTTLE (72888-093-30) 2022-07-01 0000-00-00 No No Current