Home NDC 42571-470-01 Bisoprolol
Product NDC 42571-470
Requested package NDC 42571-470-01
11-digit product format 425710470
Labeler code 42571
Product ID 42571-470_4cbe74e3-3af3-2b98-e063-6294a90a1c2b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bisoprolol Fumarate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Micro Labs Limited
Application ANDA218303
Marketing category ANDA
Marketing start 2026-06-01
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A218303-001 BISOPROLOL FUMARATE BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2026-03-09 A218303-002 BISOPROLOL FUMARATE BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2026-03-09
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 2026-09-14 22:38:34 2026-08 A218303-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2026-03-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218303-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2026-03-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218303-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2026-03-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218303-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2026-03-09 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218303-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2026-03-09 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218303-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2026-03-09 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Bisoprolol
Listing expiration 2027-12-31 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# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 42571-470-01 42571047001 100 TABLET, FILM COATED in 1 BOTTLE (42571-470-01) 2026-06-01 No No Current