Nadolol and Bendroflumethiazide

Product NDC
0115-5322
11-digit product format
001155322
Labeler code
0115
Product ID
0115-5322_2669933a-33f4-478a-bd9d-9fe48429bcc9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NADOLOL and BENDROFLUMETHIAZIDE
Dosage form
TABLET
Route
ORAL
Labeler
Impax Generics
Application
ANDA077833
Marketing category
ANDA
Marketing start
2007-03-30
Marketing end
0000-00-00
Substance
NADOLOL; BENDROFLUMETHIAZIDE
Active strength
80 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
c3e14ce3-3dd7-c88b-aff9-2af221ac8a37Product name920240606
8fcb295c-5817-6981-e90d-9999d4e8f347Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0115-5322-01Nadolol and Bendroflumethiazide100 in 1 BOTTLETABLET1006
0115-5322-02Nadolol and Bendroflumethiazide500 in 1 BOTTLETABLET5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-5322-01EA - Each0115-53223a36d339-80e3-46b4-9e75-90f97717b2b312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENDROFLUMETHIAZIDEACTIVE INGREDIENT5Q52X6ICJINADOLOL AND BENDROFLUMETHIAZIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]4
NADOLOLACTIVE INGREDIENTFEN504330VNADOLOL AND BENDROFLUMETHIAZIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]4
BENDROFLUMETHIAZIDEACTIVE MOIETY5Q52X6ICJINADOLOL AND BENDROFLUMETHIAZIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]4
NADOLOLACTIVE MOIETYFEN504330VNADOLOL AND BENDROFLUMETHIAZIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNADOLOL AND BENDROFLUMETHIAZIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NADOLOL AND BENDROFLUMETHIAZIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONADOLOL AND BENDROFLUMETHIAZIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNADOLOL AND BENDROFLUMETHIAZIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NADOLOL AND BENDROFLUMETHIAZIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]4
MANNITOLINACTIVE INGREDIENT3OWL53L36ANADOLOL AND BENDROFLUMETHIAZIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNADOLOL AND BENDROFLUMETHIAZIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1UNADOLOL AND BENDROFLUMETHIAZIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-5322NADOLOL AND BENDROFLUMETHIAZIDE TABLET [IMPAX GENERICS]6Legacy NDC, 2 package rows20160416_d2d226ea-1624-47ee-82bf-e9660b75029f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198000nadolol 40 MG / bendroflumethiazide 5 MG Oral TabletPSNd2d226ea-1624-47ee-82bf-e9660b75029f6
198001nadolol 80 MG / bendroflumethiazide 5 MG Oral TabletPSNd2d226ea-1624-47ee-82bf-e9660b75029f6
198000bendroflumethiazide 5 MG / nadolol 40 MG Oral TabletSCDd2d226ea-1624-47ee-82bf-e9660b75029f6
198001bendroflumethiazide 5 MG / nadolol 80 MG Oral TabletSCDd2d226ea-1624-47ee-82bf-e9660b75029f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0115-5322-0100115532201100 in 1 BOTTLEHistorical
0115-5322-0200115532202500 in 1 BOTTLEHistorical