Ziac

Product NDC
51285-050
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

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

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