FDA.reportPublic FDA data

Bisoprolol Fumarate and Hydrochlorothiazide

Product NDC
72578-114
11-digit product format
725780114
Labeler code
72578
Product ID
72578-114_3466b097-8648-4110-a130-8754da1f2739
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bisoprolol fumarate and hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Viona Pharmaceuticals Inc
Application
ANDA215666
Marketing category
ANDA
Marketing start
2023-03-01
Substance
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
Active strength
5; 6.25 mg/1; mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], 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 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215666-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2022-11-04
A215666-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2022-11-04
A215666-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2022-11-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A215666-001AB
A215666-002AB
A215666-003AB

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A215666-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2022-11-04c2088c7a36db…
2026-10-15 13:18:302026-09A215666-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2022-11-04c2088c7a36db…
2026-10-15 13:18:302026-09A215666-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2022-11-04c2088c7a36db…
2026-09-14 22:38:342026-08A215666-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2022-11-0484e616aacf4f…
2026-09-14 22:38:342026-08A215666-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2022-11-0484e616aacf4f…
2026-09-14 22:38:342026-08A215666-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2022-11-0484e616aacf4f…
2026-08-18 06:07:402026-07A215666-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2022-11-04caaa826d4ba7…
2026-08-18 06:07:402026-07A215666-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2022-11-04caaa826d4ba7…
2026-08-18 06:07:402026-07A215666-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2022-11-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215666-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2022-11-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215666-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2022-11-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215666-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2022-11-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215666-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2022-11-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215666-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2022-11-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215666-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2022-11-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A215666-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2022-11-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215666-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2022-11-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215666-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2022-11-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215666-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2022-11-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215666-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2022-11-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215666-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2022-11-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215666-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2022-11-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215666-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2022-11-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215666-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2022-11-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215666-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2022-11-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215666-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2022-11-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215666-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2022-11-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215666-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2022-11-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215666-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2022-11-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215666-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2022-11-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215666-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2022-11-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215666-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2022-11-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215666-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2022-11-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215666-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2022-11-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215666-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2022-11-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215666-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2022-11-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215666-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2022-11-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A215666-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2022-11-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A215666-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2022-11-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215666-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2022-11-0479d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A215666-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A215666-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A215666-003AB1c2088c7a36db…
2026-09-14 22:38:342026-08A215666-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A215666-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A215666-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A215666-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215666-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215666-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215666-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215666-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215666-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215666-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215666-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215666-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215666-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215666-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215666-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215666-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215666-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215666-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215666-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215666-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215666-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215666-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215666-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215666-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215666-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215666-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215666-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215666-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215666-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215666-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215666-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215666-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215666-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215666-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A215666-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A215666-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215666-001AB179d66fd596c7…

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 Fumarate and Hydrochlorothiazide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISOPROLOL FUMARATE5 mg/1
HYDROCHLOROTHIAZIDE6.25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
UR59KN573LInternal UNII lookup
0J48LPH2THInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
854908Internal RxNorm lookup
854916Internal RxNorm lookup
854919Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
57505d73-f2a8-430b-8703-a0a6bb733c7dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
97e4a60d-917d-ef62-dc8a-bd557b62b708Product name720260129
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612
c27b049d-3258-48cf-ebe5-08c236ae78e2Product name320190610
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
ea069444-e874-4c28-833f-d2f52734ef4dProduct name120150206
041df61b-f8b6-48a6-7b67-411e1412678bProduct name120140508
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
433a3439-b8f3-d13a-d2c8-9b221d628d60Product name120140508
59212689-39e5-a976-6d21-882d76d8079aProduct name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508
df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72578-114-01Bisoprolol Fumarate and Hydrochlorothiazide100 in 1 BOTTLETABLET, FILM COATED1003
72578-114-05Bisoprolol Fumarate and Hydrochlorothiazide500 in 1 BOTTLETABLET, FILM COATED5003
72578-114-06Bisoprolol Fumarate and Hydrochlorothiazide30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-114-01EA - Each72578-1149a928d0b-0fe6-4e31-96df-0b1d4decd39812024-05-16
72578-114-05EA - Each72578-1148a98179c-94b6-4f05-ad07-4a4effbfb5f812024-05-16
72578-114-06EA - Each72578-11489594155-80fa-497d-92e9-2dfac9e9454c12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-114BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [VIONA PHARMACEUTICALS INC]3Current NDC, 3 package rows20240112_57505d73-f2a8-430b-8703-a0a6bb733c7d.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEViona Pharmaceuticals Inc57505d73-f2a8-430b-8703-a0a6bb733c7d2026-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215666
application number: ANDA215666
ndc (product): 72578-114
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEZydus Lifesciences Limited35ed3030-a9b3-4e4e-99cd-6d5c31ad22fa2022-11-07Exact identifier
application applno (ANDA): 215666
application number: ANDA215666

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854908bisoprolol fumarate 10 MG / hydroCHLOROthiazide 6.25 MG Oral TabletPSN57505d73-f2a8-430b-8703-a0a6bb733c7d3
854916bisoprolol fumarate 2.5 MG / hydroCHLOROthiazide 6.25 MG Oral TabletPSN57505d73-f2a8-430b-8703-a0a6bb733c7d3
854919bisoprolol fumarate 5 MG / hydroCHLOROthiazide 6.25 MG Oral TabletPSN57505d73-f2a8-430b-8703-a0a6bb733c7d3
854908bisoprolol fumarate 10 MG / hydrochlorothiazide 6.25 MG Oral TabletSCD57505d73-f2a8-430b-8703-a0a6bb733c7d3
854916bisoprolol fumarate 2.5 MG / hydrochlorothiazide 6.25 MG Oral TabletSCD57505d73-f2a8-430b-8703-a0a6bb733c7d3
854919bisoprolol fumarate 5 MG / hydrochlorothiazide 6.25 MG Oral TabletSCD57505d73-f2a8-430b-8703-a0a6bb733c7d3
854908bisoprolol fumarate 10 MG / HCTZ 6.25 MG Oral TabletSY57505d73-f2a8-430b-8703-a0a6bb733c7d3
854916bisoprolol fumarate 2.5 MG / HCTZ 6.25 MG Oral TabletSY57505d73-f2a8-430b-8703-a0a6bb733c7d3
854919bisoprolol fumarate 5 MG / HCTZ 6.25 MG Oral TabletSY57505d73-f2a8-430b-8703-a0a6bb733c7d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72578-114-0172578011401100 TABLET, FILM COATED in 1 BOTTLE (72578-114-01) 2023-03-01NoNoCurrent
72578-114-0572578011405500 TABLET, FILM COATED in 1 BOTTLE (72578-114-05) 2023-03-01NoNoCurrent
72578-114-067257801140630 TABLET, FILM COATED in 1 BOTTLE (72578-114-06) 2023-03-01NoNoCurrent