FDA.reportPublic FDA data

Bumetanide

Product NDC
0185-0128
11-digit product format
001850128
Labeler code
0185
Product ID
0185-0128_c6f31ac9-10d1-4d92-882e-836de10e1ce6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bumetanide
Dosage form
TABLET
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA074700
Marketing category
ANDA
Marketing start
1996-11-21
Substance
BUMETANIDE
Active strength
.5 mg/1
Pharmacologic classes
Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bumetanide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUMETANIDE.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0Y2S3XUQ5H
Rxcui197417, 197418, 197419

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1d3f2f0a-cce7-32fe-77bf-6ee61839e736Product name920260113
601d9750-f415-d9d9-619c-0a87b4d3f237Product name320250331
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
1d3f2f0a-cce7-32fe-77bf-6ee61839e736Product name220171211

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0185-0128-01Bumetanide100 in 1 BOTTLETABLET10021
0185-0128-05Bumetanide500 in 1 BOTTLETABLET50021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0185-0128-01EA - Each0185-012865c63f39-d913-4a59-ba7d-d110bf74d00612012-07-24
0185-0128-05EA - Each0185-012855cc4a39-2541-4d56-aa50-e98b7b39d32e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUMETANIDEACTIVE INGREDIENT0Y2S3XUQ5HBUMETANIDE TABLET [EON LABS, INC.]14
BUMETANIDEACTIVE MOIETY0Y2S3XUQ5HBUMETANIDE TABLET [EON LABS, INC.]14
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBUMETANIDE TABLET [EON LABS, INC.]14
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUMETANIDE TABLET [EON LABS, INC.]14
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBUMETANIDE TABLET [EON LABS, INC.]14
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBUMETANIDE TABLET [EON LABS, INC.]14
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABUMETANIDE TABLET [EON LABS, INC.]14
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BUMETANIDE TABLET [EON LABS, INC.]14
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTBUMETANIDE TABLET [EON LABS, INC.]14
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357BUMETANIDE TABLET [EON LABS, INC.]14
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUMETANIDE TABLET [EON LABS, INC.]14
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBUMETANIDE TABLET [EON LABS, INC.]14
TALCINACTIVE INGREDIENT7SEV7J4R1UBUMETANIDE TABLET [EON LABS, INC.]14
BUMETANIDEACTIVE INGREDIENT0Y2S3XUQ5HBUMETANIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
BUMETANIDEACTIVE MOIETY0Y2S3XUQ5HBUMETANIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBUMETANIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUMETANIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBUMETANIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBUMETANIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABUMETANIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BUMETANIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTBUMETANIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357BUMETANIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUMETANIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBUMETANIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1UBUMETANIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0185-0128BUMETANIDE TABLET [SANDOZ INC]21Current NDC, Legacy NDC, 2 package rows20240322_05cb961d-ac33-4bcf-b04e-411e496c43c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197417bumetanide 0.5 MG Oral TabletPSN80fe034e-01b7-438e-8378-44fafb7a1d94102
197417bumetanide 0.5 MG Oral TabletSCD80fe034e-01b7-438e-8378-44fafb7a1d94102
197417bumetanide 0.5 MG Oral TabletPSN05cb961d-ac33-4bcf-b04e-411e496c43c121
197418bumetanide 1 MG Oral TabletPSN05cb961d-ac33-4bcf-b04e-411e496c43c121
197419bumetanide 2 MG Oral TabletPSN05cb961d-ac33-4bcf-b04e-411e496c43c121
197417bumetanide 0.5 MG Oral TabletSCD05cb961d-ac33-4bcf-b04e-411e496c43c121
197418bumetanide 1 MG Oral TabletSCD05cb961d-ac33-4bcf-b04e-411e496c43c121
197419bumetanide 2 MG Oral TabletSCD05cb961d-ac33-4bcf-b04e-411e496c43c121
197417bumetanide 0.5 MG Oral TabletPSNd91945d7-f626-4ae2-b252-c88a38fc9ca14
197418bumetanide 1 MG Oral TabletPSNd91945d7-f626-4ae2-b252-c88a38fc9ca14
197419bumetanide 2 MG Oral TabletPSNd91945d7-f626-4ae2-b252-c88a38fc9ca14
197417bumetanide 0.5 MG Oral TabletSCDd91945d7-f626-4ae2-b252-c88a38fc9ca14
197418bumetanide 1 MG Oral TabletSCDd91945d7-f626-4ae2-b252-c88a38fc9ca14
197419bumetanide 2 MG Oral TabletSCDd91945d7-f626-4ae2-b252-c88a38fc9ca14
197417bumetanide 0.5 MG Oral TabletPSNf6ff0d37-c67d-4b9f-8b62-5deda9783c281
197417bumetanide 0.5 MG Oral TabletSCDf6ff0d37-c67d-4b9f-8b62-5deda9783c281

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0185-0128-0100185012801100 TABLET in 1 BOTTLE (0185-0128-01) 100 tablet1996-11-210000-00-00NoNoCurrent
0185-0128-0500185012805500 TABLET in 1 BOTTLE (0185-0128-05) 500 tablet1996-11-210000-00-00NoNoCurrent