Ziac

Product NDC
51285-050
Requested package NDC
51285-050-02
11-digit product format
512850050
Labeler code
51285
Product ID
51285-050_94889ecb-45cb-40e5-ac51-602e8f37b7bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bisoprolol fumarate and hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Women's Health, Inc.
Application
NDA020186
Marketing category
NDA
Marketing start
1993-10-26
Marketing end
0000-00-00
Substance
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
Active strength
5 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
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage51285-05051285-050-02DDiscontinued by firm2026-10-05

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51285-05051285-050-02DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51285-05051285-050-02DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
N020186-001ZIACBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE5MG;6.25MGTABLET / ORALABRLD1993-03-26
N020186-002ZIACBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE10MG;6.25MGTABLET / ORALABRLD, RS1993-03-26
N020186-003ZIACBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE2.5MG;6.25MGTABLET / ORALABRLD1993-03-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020186-001AB
N020186-002AB
N020186-003AB

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 22:38:342026-08N020186-001ZIAC5MG;6.25MGTABLET / ORALABRLD1993-03-2684e616aacf4f…
2026-09-14 22:38:342026-08N020186-002ZIAC10MG;6.25MGTABLET / ORALABRLD, RS1993-03-2684e616aacf4f…
2026-09-14 22:38:342026-08N020186-003ZIAC2.5MG;6.25MGTABLET / ORALABRLD1993-03-2684e616aacf4f…
2026-08-18 06:07:402026-07N020186-001ZIAC5MG;6.25MGTABLET / ORALABRLD1993-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07N020186-002ZIAC10MG;6.25MGTABLET / ORALABRLD, RS1993-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07N020186-003ZIAC2.5MG;6.25MGTABLET / ORALABRLD1993-03-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020186-001ZIAC5MG;6.25MGTABLET / ORALABRLD1993-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020186-002ZIAC10MG;6.25MGTABLET / ORALABRLD, RS1993-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020186-003ZIAC2.5MG;6.25MGTABLET / ORALABRLD1993-03-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020186-001ZIAC5MG;6.25MGTABLET / ORALABRLD1993-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020186-002ZIAC10MG;6.25MGTABLET / ORALABRLD, RS1993-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020186-003ZIAC2.5MG;6.25MGTABLET / ORALABRLD1993-03-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N020186-001ZIAC5MG;6.25MGTABLET / ORALABRLD1993-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020186-002ZIAC10MG;6.25MGTABLET / ORALABRLD, RS1993-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020186-003ZIAC2.5MG;6.25MGTABLET / ORALABRLD1993-03-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020186-001ZIAC5MG;6.25MGTABLET / ORALABRLD1993-03-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020186-002ZIAC10MG;6.25MGTABLET / ORALABRLD, RS1993-03-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020186-003ZIAC2.5MG;6.25MGTABLET / ORALABRLD1993-03-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020186-001ZIAC5MG;6.25MGTABLET / ORALABRLD1993-03-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020186-002ZIAC10MG;6.25MGTABLET / ORALABRLD, RS1993-03-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020186-003ZIAC2.5MG;6.25MGTABLET / ORALABRLD1993-03-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020186-001ZIAC5MG;6.25MGTABLET / ORALABRLD1993-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020186-002ZIAC10MG;6.25MGTABLET / ORALABRLD, RS1993-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020186-003ZIAC2.5MG;6.25MGTABLET / ORALABRLD1993-03-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020186-001ZIAC5MG;6.25MGTABLET / ORALABRLD1993-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020186-002ZIAC10MG;6.25MGTABLET / ORALABRLD, RS1993-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020186-003ZIAC2.5MG;6.25MGTABLET / ORALABRLD1993-03-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020186-001ZIAC5MG;6.25MGTABLET / ORALABRLD1993-03-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020186-002ZIAC10MG;6.25MGTABLET / ORALABRLD, RS1993-03-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020186-003ZIAC2.5MG;6.25MGTABLET / ORALABRLD1993-03-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020186-001ZIAC5MG;6.25MGTABLET / ORALABRLD1993-03-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020186-002ZIAC10MG;6.25MGTABLET / ORALABRLD, RS1993-03-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020186-003ZIAC2.5MG;6.25MGTABLET / ORALABRLD1993-03-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020186-001ZIAC5MG;6.25MGTABLET / ORALABRLD1993-03-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N020186-002ZIAC10MG;6.25MGTABLET / ORALABRLD, RS1993-03-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N020186-003ZIAC2.5MG;6.25MGTABLET / ORALABRLD1993-03-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020186-001ZIAC5MG;6.25MGTABLET / ORALABRLD1993-03-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020186-002ZIAC10MG;6.25MGTABLET / ORALABRLD, RS1993-03-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020186-003ZIAC2.5MG;6.25MGTABLET / ORALABRLD1993-03-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020186-001ZIAC5MG;6.25MGTABLET / ORALABRLD1993-03-26301d65b070ca…

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 22:38:342026-08N020186-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N020186-002AB184e616aacf4f…
2026-09-14 22:38:342026-08N020186-003AB184e616aacf4f…
2026-08-18 06:07:402026-07N020186-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020186-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020186-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020186-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020186-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020186-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020186-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020186-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020186-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020186-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020186-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020186-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020186-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020186-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020186-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020186-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020186-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020186-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020186-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020186-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020186-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020186-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020186-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020186-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020186-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020186-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020186-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020186-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020186-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020186-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020186-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020186-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020186-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020186-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020186-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020186-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020186-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51285-050-02EA - Each51285-0502026f0b6-b06c-47e8-9e5c-f2071ac1df8712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISOPROLOL FUMARATEACTIVE INGREDIENTUR59KN573LZIAC (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.]6
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THZIAC (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.]6
BISOPROLOLACTIVE MOIETYY41JS2NL6UZIAC (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.]6
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THZIAC (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.]6
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JZIAC (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZIAC (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.]6
CROSPOVIDONEINACTIVE INGREDIENT68401960MKZIAC (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.]6
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPZIAC (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZIAC (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTZIAC (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZIAC (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZIAC (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.]6
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AZIAC (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.]6
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HZIAC (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZIAC (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJZIAC (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZIAC (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51285-050ZIAC (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH LLC]23Legacy NDC20240109_238176e5-df10-457b-a5cf-c950a583e748.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 HYDROCHLOROTHIAZIDETeva Pharmaceuticals USA, Inc.27d52b23-e3e2-4339-b00e-cd0fec43ffbb2026-08-11Warnings, Adverse reactionsExact identifier
application applno (NDA): 020186
application number: NDA020186
bisoprolol fumarate and hydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEA-S Medication Solutionscf088009-203e-4d70-b56e-b4062cf3fcd82023-05-19Warnings, Adverse reactionsExact identifier
application applno (NDA): 020186
application number: NDA020186

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51285-050-0251285005002100 TABLET, FILM COATED in 1 BOTTLE (51285-050-02) 1993-10-260000-00-00NoNoCurrent