Bisoprolol Fumarate Tablets, USP

Manufacturer
Zydus Lifesciences Limited
Effective date
2024-08-14
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 21:10:42

Label at a glance#

ProductBisoprolol Fumarate
Active ingredientBISOPROLOL FUMARATE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1726-3

Bisoprolol Fumarate Tablets USP, 5 mg

30 Tablets

Unit-of-Use

Rx only

5 mg label
5 mg label

NDC 70771-1727-3

Bisoprolol Fumarate Tablets USP, 10 mg

30 Tablets

Unit-of-Use

Rx only

10 mg label
10 mg label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
854901bisoprolol fumarate 10 MG Oral TabletPSN2
854905bisoprolol fumarate 5 MG Oral TabletPSN2
854901bisoprolol fumarate 10 MG Oral TabletSCD2
854905bisoprolol fumarate 5 MG Oral TabletSCD2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BISOPROLOL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
97e4a60d-917d-ef62-dc8a-bd557b62b708Product name720260129
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1726-1Bisoprolol Fumarate100 in 1 BOTTLETABLET, FILM COATED1002
70771-1726-3Bisoprolol Fumarate30 in 1 BOTTLETABLET, FILM COATED302
70771-1727-1Bisoprolol Fumarate100 in 1 BOTTLETABLET, FILM COATED1002
70771-1727-3Bisoprolol Fumarate30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1726BISOPROLOL FUMARATE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]2Current NDC, Legacy NDC, 2 package rows20240817_2d380e61-052c-4c33-8a35-01c9eb651d68.zip
70771-1727BISOPROLOL FUMARATE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]2Current NDC, Legacy NDC, 2 package rows20240817_2d380e61-052c-4c33-8a35-01c9eb651d68.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70771-172670771-1726-3, 70771-1726-1
70771-172770771-1727-3, 70771-1727-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215680-001BISOPROLOL FUMARATEBISOPROLOL FUMARATE5MGTABLET / ORALAB2022-07-25
A215680-002BISOPROLOL FUMARATEBISOPROLOL FUMARATE10MGTABLET / ORALAB2022-07-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A215680-001AB
A215680-002AB

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 2 · 60 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A215680-001BISOPROLOL FUMARATE5MGTABLET / ORALAB2022-07-25c2088c7a36db…
2026-10-15 13:18:302026-09A215680-002BISOPROLOL FUMARATE10MGTABLET / ORALAB2022-07-25c2088c7a36db…
2026-09-14 22:38:342026-08A215680-001BISOPROLOL FUMARATE5MGTABLET / ORALAB2022-07-2584e616aacf4f…
2026-09-14 22:38:342026-08A215680-002BISOPROLOL FUMARATE10MGTABLET / ORALAB2022-07-2584e616aacf4f…
2026-08-18 06:07:402026-07A215680-001BISOPROLOL FUMARATE5MGTABLET / ORALAB2022-07-25caaa826d4ba7…
2026-08-18 06:07:402026-07A215680-002BISOPROLOL FUMARATE10MGTABLET / ORALAB2022-07-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215680-001BISOPROLOL FUMARATE5MGTABLET / ORALAB2022-07-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215680-002BISOPROLOL FUMARATE10MGTABLET / ORALAB2022-07-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215680-001BISOPROLOL FUMARATE5MGTABLET / ORALAB2022-07-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215680-002BISOPROLOL FUMARATE10MGTABLET / ORALAB2022-07-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A215680-001BISOPROLOL FUMARATE5MGTABLET / ORALAB2022-07-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215680-002BISOPROLOL FUMARATE10MGTABLET / ORALAB2022-07-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215680-001BISOPROLOL FUMARATE5MGTABLET / ORALAB2022-07-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215680-002BISOPROLOL FUMARATE10MGTABLET / ORALAB2022-07-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215680-001BISOPROLOL FUMARATE5MGTABLET / ORALAB2022-07-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215680-002BISOPROLOL FUMARATE10MGTABLET / ORALAB2022-07-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215680-001BISOPROLOL FUMARATE5MGTABLET / ORALAB2022-07-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215680-002BISOPROLOL FUMARATE10MGTABLET / ORALAB2022-07-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215680-001BISOPROLOL FUMARATE5MGTABLET / ORALAB2022-07-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215680-002BISOPROLOL FUMARATE10MGTABLET / ORALAB2022-07-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215680-001BISOPROLOL FUMARATE5MGTABLET / ORALAB2022-07-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215680-002BISOPROLOL FUMARATE10MGTABLET / ORALAB2022-07-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215680-001BISOPROLOL FUMARATE5MGTABLET / ORALAB2022-07-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215680-002BISOPROLOL FUMARATE10MGTABLET / ORALAB2022-07-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215680-001BISOPROLOL FUMARATE5MGTABLET / ORALAB2022-07-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A215680-002BISOPROLOL FUMARATE10MGTABLET / ORALAB2022-07-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215680-001BISOPROLOL FUMARATE5MGTABLET / ORALAB2022-07-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215680-002BISOPROLOL FUMARATE10MGTABLET / ORALAB2022-07-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215680-001BISOPROLOL FUMARATE5MGTABLET / ORALAB2022-07-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215680-002BISOPROLOL FUMARATE10MGTABLET / ORALAB2022-07-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215680-001BISOPROLOL FUMARATE5MGTABLET / ORALAB2022-07-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215680-002BISOPROLOL FUMARATE10MGTABLET / ORALAB2022-07-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215680-001BISOPROLOL FUMARATE5MGTABLET / ORALAB2022-07-258072bd15b7f6…
2024-05-31 18:47 UTC2024-05A215680-002BISOPROLOL FUMARATE10MGTABLET / ORALAB2022-07-258072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215680-001BISOPROLOL FUMARATE5MGTABLET / ORALAB2022-07-256a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215680-002BISOPROLOL FUMARATE10MGTABLET / ORALAB2022-07-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215680-001BISOPROLOL FUMARATE5MGTABLET / ORALAB2022-07-251c564ffb4f44…
2024-02-18 07:12 UTC2024-02A215680-002BISOPROLOL FUMARATE10MGTABLET / ORALAB2022-07-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215680-001BISOPROLOL FUMARATE5MGTABLET / ORALAB2022-07-25ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A215680-002BISOPROLOL FUMARATE10MGTABLET / ORALAB2022-07-25ea1830bbd6c7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A215680-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A215680-002AB1c2088c7a36db…
2026-09-14 22:38:342026-08A215680-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A215680-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A215680-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215680-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215680-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215680-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215680-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215680-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215680-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215680-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215680-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215680-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215680-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215680-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215680-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215680-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215680-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215680-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215680-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215680-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215680-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215680-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215680-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A215680-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215680-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215680-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215680-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215680-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215680-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215680-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215680-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A215680-002AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215680-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215680-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215680-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A215680-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215680-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A215680-002AB1ea1830bbd6c7…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bisoprolol FumarateBISOPROLOL FUMARATEZydus Lifesciences Limited2d380e61-052c-4c33-8a35-01c9eb651d682024-08-14Exact identifier
ndc (package): 70771-1727-1
ndc (package): 70771-1726-1
ndc (package): 70771-1727-3
ndc (package): 70771-1726-3
ndc (product): 70771-1727
ndc (product): 70771-1726
ndc11 (package): 70771172701
ndc11 (package): 70771172603
ndc11 (package): 70771172601
ndc11 (package): 70771172703
spl id: bd36cf67-11ab-4a1f-b1b6-9d5c078a9206
spl set id: 2d380e61-052c-4c33-8a35-01c9eb651d68

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.