FDA.reportPublic FDA data

Bisoprolol Fumarate and Hydrochlorothiazide

Product NDC
59651-678
11-digit product format
596510678
Labeler code
59651
Product ID
59651-678_e9aaa10f-eb85-40a2-bc1e-f4031fbebe3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bisoprolol Fumarate and Hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA217922
Marketing category
ANDA
Marketing start
2026-01-21
Substance
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
Active strength
2.5; 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 43.

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
A217922-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2026-01-21
A217922-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2026-01-21
A217922-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2026-01-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217922-001AB
A217922-002AB
A217922-003AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A217922-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2026-01-2184e616aacf4f…
2026-09-14 22:38:342026-08A217922-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2026-01-2184e616aacf4f…
2026-09-14 22:38:342026-08A217922-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2026-01-2184e616aacf4f…
2026-08-18 06:07:402026-07A217922-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2026-01-21caaa826d4ba7…
2026-08-18 06:07:402026-07A217922-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2026-01-21caaa826d4ba7…
2026-08-18 06:07:402026-07A217922-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2026-01-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217922-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2026-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217922-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2026-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217922-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2026-01-21011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217922-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2026-01-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217922-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2026-01-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217922-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2026-01-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A217922-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A217922-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A217922-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A217922-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A217922-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A217922-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217922-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217922-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217922-003AB1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217922-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217922-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217922-003AB1a50c72e98297…

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 FUMARATE2.5 mg/1
HYDROCHLOROTHIAZIDE6.25 mg/1

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
59651-678-01Bisoprolol Fumarate and Hydrochlorothiazide100 in 1 BOTTLETABLET, FILM COATED1001
59651-678-05Bisoprolol Fumarate and Hydrochlorothiazide500 in 1 BOTTLETABLET, FILM COATED5001
59651-678-30Bisoprolol Fumarate and Hydrochlorothiazide30 in 1 BOTTLETABLET, FILM COATED301

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 Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEAurobindo Pharma Limited2db1a899-f115-4da5-89fe-6e5b41086f6c2026-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217922
application number: ANDA217922
ndc (product): 59651-678

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854908bisoprolol fumarate 10 MG / hydroCHLOROthiazide 6.25 MG Oral TabletPSN2db1a899-f115-4da5-89fe-6e5b41086f6c1
854916bisoprolol fumarate 2.5 MG / hydroCHLOROthiazide 6.25 MG Oral TabletPSN2db1a899-f115-4da5-89fe-6e5b41086f6c1
854919bisoprolol fumarate 5 MG / hydroCHLOROthiazide 6.25 MG Oral TabletPSN2db1a899-f115-4da5-89fe-6e5b41086f6c1
854908bisoprolol fumarate 10 MG / hydrochlorothiazide 6.25 MG Oral TabletSCD2db1a899-f115-4da5-89fe-6e5b41086f6c1
854916bisoprolol fumarate 2.5 MG / hydrochlorothiazide 6.25 MG Oral TabletSCD2db1a899-f115-4da5-89fe-6e5b41086f6c1
854919bisoprolol fumarate 5 MG / hydrochlorothiazide 6.25 MG Oral TabletSCD2db1a899-f115-4da5-89fe-6e5b41086f6c1
854908bisoprolol fumarate 10 MG / HCTZ 6.25 MG Oral TabletSY2db1a899-f115-4da5-89fe-6e5b41086f6c1
854916bisoprolol fumarate 2.5 MG / HCTZ 6.25 MG Oral TabletSY2db1a899-f115-4da5-89fe-6e5b41086f6c1
854919bisoprolol fumarate 5 MG / HCTZ 6.25 MG Oral TabletSY2db1a899-f115-4da5-89fe-6e5b41086f6c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
59651-678-0159651067801100 TABLET, FILM COATED in 1 BOTTLE (59651-678-01) 2026-01-21NoNoCurrent
59651-678-0559651067805500 TABLET, FILM COATED in 1 BOTTLE (59651-678-05) 2026-01-21NoNoCurrent
59651-678-305965106783030 TABLET, FILM COATED in 1 BOTTLE (59651-678-30) 2026-01-21NoNoCurrent