Home NDC 70095-019 BISOPROLOL FUMARATE
Product NDC 70095-019
11-digit product format 700950019
Labeler code 70095
Product ID 70095-019_6ce4dc4f-ad08-424e-b90d-400de0b7050a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name BISOPROLOL FUMARATE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sun Pharmaceutical Industries Limited
Application ANDA217617
Marketing category ANDA
Marketing start 2024-03-10
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217617-001 BISOPROLOL FUMARATE BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2024-01-18 A217617-002 BISOPROLOL FUMARATE BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2024-01-18
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 A217617-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2024-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217617-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2024-01-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217617-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2024-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217617-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2024-01-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217617-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2024-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217617-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2024-01-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217617-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2024-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217617-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2024-01-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217617-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2024-01-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217617-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2024-01-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217617-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2024-01-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217617-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2024-01-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217617-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2024-01-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217617-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2024-01-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217617-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2024-01-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217617-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2024-01-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217617-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2024-01-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217617-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2024-01-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217617-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2024-01-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217617-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2024-01-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217617-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2024-01-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217617-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2024-01-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217617-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2024-01-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217617-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2024-01-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217617-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2024-01-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217617-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2024-01-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217617-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2024-01-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A217617-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2024-01-18 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217617-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2024-01-18 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217617-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2024-01-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217617-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2024-01-18 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A217617-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2024-01-18 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217617-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2024-01-18 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217617-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2024-01-18 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 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 · 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 70095-019-01 BISOPROLOL FUMARATE 30 in 1 BOTTLE, UNIT-DOSE TABLET, FILM COATED 30 3 70095-019-02 BISOPROLOL FUMARATE 100 in 1 BOTTLE TABLET, FILM COATED 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70095-019 BISOPROLOL FUMARATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 Current NDC, 2 package rows 20241106_7556f457-c4d3-49d6-b383-0ade6d489091.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 · 4 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 70095-019-01 70095001901 30 TABLET, FILM COATED in 1 BOTTLE, UNIT-DOSE (70095-019-01) 2024-03-10 No No Current 70095-019-02 70095001902 100 TABLET, FILM COATED in 1 BOTTLE (70095-019-02) 2024-03-10 No No Current