bisoprolol fumarate and hydrochlorothiazide

Product NDC
33261-918
11-digit product format
332610918
Labeler code
33261
Product ID
33261-918_67b56f89-ea09-427c-95ff-f358b6eb256e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bisoprolol fumarate and hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA079106
Marketing category
ANDA
Marketing start
2010-10-12
Marketing end
0000-00-00
Substance
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
Active strength
5 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
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
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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
33261-918-602020-01-31C16284748780-19d75b9d0-ffbb-f424-e053-dadaa90a57ceBisoprolol Fumarate and Hydrochlorothiazide Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-918-60bisoprolol fumarate and hydrochlorothiazide60 in 1 BOTTLE, PLASTICTABLET602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-918-60EA - Each33261-9181153cd84-712e-4782-ab80-cb94521242a012015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISOPROLOL FUMARATEACTIVE INGREDIENTUR59KN573LBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]2
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]2
BISOPROLOLACTIVE MOIETYY41JS2NL6UBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]2
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]2
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]2
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]2
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-918BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]2Legacy NDC, 1 package rows20140327_b3afd73f-4640-4a73-aed1-66c46fe533dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854919bisoprolol fumarate 5 MG / hydroCHLOROthiazide 6.25 MG Oral TabletPSNb3afd73f-4640-4a73-aed1-66c46fe533dd2
854919bisoprolol fumarate 5 MG / hydrochlorothiazide 6.25 MG Oral TabletSCDb3afd73f-4640-4a73-aed1-66c46fe533dd2
854919bisoprolol fumarate 5 MG / HCTZ 6.25 MG Oral TabletSYb3afd73f-4640-4a73-aed1-66c46fe533dd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-918-603326109186060 in 1 BOTTLE, PLASTICHistorical