Bisoprolol Fumarate and Hydrochlorothiazide

Product NDC
0185-0707
11-digit product format
001850707
Labeler code
0185
Product ID
0185-0707_a565d200-0d77-4447-b66a-38e344afa792
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bisoprolol Fumarate and Hydrochlorothiazide
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Eon Labs, Inc.
Application
ANDA075579
Marketing category
ANDA
Marketing start
2000-09-25
Marketing end
2021-06-30
Substance
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
Active strength
10 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
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
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b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
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9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
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433a3439-b8f3-d13a-d2c8-9b221d628d60Product name120140508
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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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0185-0707-01EA - Each0185-070741c52c75-d1fc-4af7-bc41-f3227b719e3612012-07-24
0185-0707-05EA - Each0185-0707137aef3a-ba53-4b27-a79c-c1b7700140c512012-07-24
0185-0707-30EA - Each0185-07070c37c241-041f-472c-806b-24898a3d936512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISOPROLOL FUMARATEACTIVE INGREDIENTUR59KN573LBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]2
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]2
BISOPROLOLACTIVE MOIETYY41JS2NL6UBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]2
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]2
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ABISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]2
bisoprolol fumarateACTIVE INGREDIENTUR59KN573LBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [REBEL DISTRIBUTORS CORP]1
hydrochlorothiazideACTIVE INGREDIENT0J48LPH2THBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [REBEL DISTRIBUTORS CORP]1
bisoprololACTIVE MOIETYY41JS2NL6UBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [REBEL DISTRIBUTORS CORP]1
hydrochlorothiazideACTIVE MOIETY0J48LPH2THBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [REBEL DISTRIBUTORS CORP]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [REBEL DISTRIBUTORS CORP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ABISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [REBEL DISTRIBUTORS CORP]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [REBEL DISTRIBUTORS CORP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, COATED [REBEL DISTRIBUTORS CORP]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854908bisoprolol fumarate 10 MG / hydroCHLOROthiazide 6.25 MG Oral TabletPSNec524b62-3b42-4c36-bca6-7ef442fcd4772
854916bisoprolol fumarate 2.5 MG / hydroCHLOROthiazide 6.25 MG Oral TabletPSNec524b62-3b42-4c36-bca6-7ef442fcd4772
854919bisoprolol fumarate 5 MG / hydroCHLOROthiazide 6.25 MG Oral TabletPSNec524b62-3b42-4c36-bca6-7ef442fcd4772
854908bisoprolol fumarate 10 MG / hydrochlorothiazide 6.25 MG Oral TabletSCDec524b62-3b42-4c36-bca6-7ef442fcd4772
854916bisoprolol fumarate 2.5 MG / hydrochlorothiazide 6.25 MG Oral TabletSCDec524b62-3b42-4c36-bca6-7ef442fcd4772
854919bisoprolol fumarate 5 MG / hydrochlorothiazide 6.25 MG Oral TabletSCDec524b62-3b42-4c36-bca6-7ef442fcd4772
854908bisoprolol fumarate 10 MG / HCTZ 6.25 MG Oral TabletSYec524b62-3b42-4c36-bca6-7ef442fcd4772
854916bisoprolol fumarate 2.5 MG / HCTZ 6.25 MG Oral TabletSYec524b62-3b42-4c36-bca6-7ef442fcd4772
854919bisoprolol fumarate 5 MG / HCTZ 6.25 MG Oral TabletSYec524b62-3b42-4c36-bca6-7ef442fcd4772
854908bisoprolol fumarate 10 MG / hydroCHLOROthiazide 6.25 MG Oral TabletPSN4ae433f5-52bb-4403-984c-32f0fad50dd11
854919bisoprolol fumarate 5 MG / hydroCHLOROthiazide 6.25 MG Oral TabletPSN4ae433f5-52bb-4403-984c-32f0fad50dd11
854908bisoprolol fumarate 10 MG / hydrochlorothiazide 6.25 MG Oral TabletSCD4ae433f5-52bb-4403-984c-32f0fad50dd11
854919bisoprolol fumarate 5 MG / hydrochlorothiazide 6.25 MG Oral TabletSCD4ae433f5-52bb-4403-984c-32f0fad50dd11
854908bisoprolol fumarate 10 MG / HCTZ 6.25 MG Oral TabletSY4ae433f5-52bb-4403-984c-32f0fad50dd11
854919bisoprolol fumarate 5 MG / HCTZ 6.25 MG Oral TabletSY4ae433f5-52bb-4403-984c-32f0fad50dd11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0185-0707-0100185070701100 TABLET, COATED in 1 BOTTLE (0185-0707-01) 2000-09-252021-06-30NoNoCurrent
0185-0707-300018507073030 TABLET, COATED in 1 BOTTLE (0185-0707-30) 2000-09-252021-02-28NoNoCurrent