bisoprolol fumarate and hydrochlorothiazide

Product NDC
10544-173
11-digit product format
105440173
Labeler code
10544
Product ID
10544-173_7e310381-d7dd-410f-9064-31bcea2dcc87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bisoprolol fumarate and hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA079106
Marketing category
ANDA
Marketing start
2013-11-15
Marketing end
0000-00-00
Substance
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
Active strength
3 mg/1; mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct10544-173IInactivated by FDA2026-10-05
excluded packagepackage10544-17310544-173-30IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage10544-173-30IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10544-173-30IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10544-173-30IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10544-173-30IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10544-173-30IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10544-173-30IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10544-173-30IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10544-173-30IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10544-173-30IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage10544-173-30IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage10544-173-30IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage10544-173-30IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage10544-173-30IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage10544-173-30IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage10544-173-30IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage10544-173-30IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage10544-173-30IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage10544-173-30IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage10544-173-30IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage10544-173-30IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage10544-173-30IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage10544-173-30EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
A079106-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2010-07-28
A079106-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2010-07-28
A079106-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2010-07-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A079106-001AB
A079106-002AB
A079106-003AB

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A079106-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2010-07-2884e616aacf4f…
2026-09-14 22:38:342026-08A079106-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2010-07-2884e616aacf4f…
2026-09-14 22:38:342026-08A079106-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2010-07-2884e616aacf4f…
2026-08-18 06:07:402026-07A079106-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2010-07-28caaa826d4ba7…
2026-08-18 06:07:402026-07A079106-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2010-07-28caaa826d4ba7…
2026-08-18 06:07:402026-07A079106-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2010-07-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079106-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2010-07-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079106-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2010-07-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079106-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2010-07-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079106-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2010-07-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079106-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2010-07-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079106-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2010-07-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A079106-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2010-07-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079106-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2010-07-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079106-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2010-07-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079106-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2010-07-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079106-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2010-07-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079106-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2010-07-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079106-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2010-07-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079106-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2010-07-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079106-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2010-07-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079106-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2010-07-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079106-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2010-07-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079106-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2010-07-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079106-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2010-07-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079106-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2010-07-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079106-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2010-07-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079106-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2010-07-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079106-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2010-07-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079106-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2010-07-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079106-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2010-07-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079106-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2010-07-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079106-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2010-07-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079106-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2010-07-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A079106-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2010-07-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A079106-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2010-07-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079106-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2010-07-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079106-002BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALAB2010-07-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079106-003BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALAB2010-07-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079106-001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALAB2010-07-28301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A079106-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A079106-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A079106-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A079106-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A079106-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A079106-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079106-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079106-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079106-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079106-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079106-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079106-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A079106-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079106-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079106-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079106-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079106-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079106-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079106-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079106-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079106-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079106-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079106-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079106-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079106-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079106-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079106-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079106-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079106-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079106-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079106-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079106-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079106-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079106-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A079106-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A079106-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079106-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079106-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079106-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079106-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10544-173-302020-01-31C16284748780-19d75b9d0-dd8f-f424-e053-dadaa90a57ceBisoprolol Fumarate and Hydrochlorothiazide Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-173-30bisoprolol fumarate and hydrochlorothiazide30 in 1 BOTTLE, PLASTICTABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-173-30EA - Each10544-173afe5bb06-6c49-451d-9a8b-132a5c70cfbd12015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISOPROLOL FUMARATEACTIVE INGREDIENTUR59KN573LBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
BISOPROLOLACTIVE MOIETYY41JS2NL6UBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-173BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 1 package rows20150213_7e310381-d7dd-410f-9064-31bcea2dcc87.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bisoprolol fumarate and hydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEUnichem Pharmaceuticals (USA), Inc.b9ee689a-ea12-435d-b01c-70d45891e62f2026-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079106
application number: ANDA079106
bisoprolol fumarate and hydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack447c11b6-72fe-418e-a2db-5d90b53477962024-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079106
application number: ANDA079106
bisoprolol fumarate and hydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack36fbc5fc-4a75-4aa3-bed1-78944135ae112024-05-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079106
application number: ANDA079106

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854908bisoprolol fumarate 10 MG / hydroCHLOROthiazide 6.25 MG Oral TabletPSN7e310381-d7dd-410f-9064-31bcea2dcc871
854916bisoprolol fumarate 2.5 MG / hydroCHLOROthiazide 6.25 MG Oral TabletPSN7e310381-d7dd-410f-9064-31bcea2dcc871
854919bisoprolol fumarate 5 MG / hydroCHLOROthiazide 6.25 MG Oral TabletPSN7e310381-d7dd-410f-9064-31bcea2dcc871
854908bisoprolol fumarate 10 MG / hydrochlorothiazide 6.25 MG Oral TabletSCD7e310381-d7dd-410f-9064-31bcea2dcc871
854916bisoprolol fumarate 2.5 MG / hydrochlorothiazide 6.25 MG Oral TabletSCD7e310381-d7dd-410f-9064-31bcea2dcc871
854919bisoprolol fumarate 5 MG / hydrochlorothiazide 6.25 MG Oral TabletSCD7e310381-d7dd-410f-9064-31bcea2dcc871
854908bisoprolol fumarate 10 MG / HCTZ 6.25 MG Oral TabletSY7e310381-d7dd-410f-9064-31bcea2dcc871
854916bisoprolol fumarate 2.5 MG / HCTZ 6.25 MG Oral TabletSY7e310381-d7dd-410f-9064-31bcea2dcc871
854919bisoprolol fumarate 5 MG / HCTZ 6.25 MG Oral TabletSY7e310381-d7dd-410f-9064-31bcea2dcc871

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-173-301054401733030 in 1 BOTTLE, PLASTICHistorical