Bumetanide

Product NDC
43547-897
11-digit product format
435470897
Labeler code
43547
Product ID
43547-897_4bcc6cdb-3dfa-4757-bac2-a2dc8bd3a9f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bumetanide
Dosage form
TABLET
Route
ORAL
Labeler
Solco Healthcare LLC
Application
ANDA212931
Marketing category
ANDA
Marketing start
2025-03-01
Substance
BUMETANIDE
Active strength
1 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
BUMETANIDE1 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
1d3f2f0a-cce7-32fe-77bf-6ee61839e736Product name220171211

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43547-897-10Bumetanide100 in 1 BOTTLETABLET1001
43547-897-50Bumetanide500 in 1 BOTTLETABLET5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-897-10EA - Each43547-89707df16c6-8589-4b6b-9ca6-a36e4258c00512025-03-04
43547-897-50EA - Each43547-89766556c4d-3bc4-4ac4-9857-d2c41137e52712025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-897BUMETANIDE TABLET [SOLCO HEALTHCARE LLC]1Current NDC, 2 package rows20250302_4bcc6cdb-3dfa-4757-bac2-a2dc8bd3a9f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197417bumetanide 0.5 MG Oral TabletPSN4bcc6cdb-3dfa-4757-bac2-a2dc8bd3a9f61
197418bumetanide 1 MG Oral TabletPSN4bcc6cdb-3dfa-4757-bac2-a2dc8bd3a9f61
197418bumetanide 1 MG Oral TabletPSN51d5f639-5d25-4ada-8bbe-ada2386173bf1
197419bumetanide 2 MG Oral TabletPSN4bcc6cdb-3dfa-4757-bac2-a2dc8bd3a9f61
197417bumetanide 0.5 MG Oral TabletSCD4bcc6cdb-3dfa-4757-bac2-a2dc8bd3a9f61
197418bumetanide 1 MG Oral TabletSCD4bcc6cdb-3dfa-4757-bac2-a2dc8bd3a9f61
197418bumetanide 1 MG Oral TabletSCD51d5f639-5d25-4ada-8bbe-ada2386173bf1
197419bumetanide 2 MG Oral TabletSCD4bcc6cdb-3dfa-4757-bac2-a2dc8bd3a9f61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43547-897-1043547089710100 TABLET in 1 BOTTLE (43547-897-10) 100 tablet2025-03-01NoNoCurrent
43547-897-5043547089750500 TABLET in 1 BOTTLE (43547-897-50) 500 tablet2025-03-01NoNoCurrent