FDA.reportPublic FDA data

NDC 63629-4968-06 - Bumetanide

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
63629-4968
Requested NDC
63629-4968-06
Package NDCs from labels
63629-4968-1, 63629-4968-2, 63629-4968-3, 63629-4968-4, 63629-4968-5, 63629-4968-6, 63629-4968-06
Manufacturer
Bryant Ranch Prepack
Effective date
2024-07-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Bumetanide - Bryant Ranch PrepackBryant Ranch Prepack2024-07-24HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63629-4968-12020-10-16Bumetanide Tablets, USP
63629-4968-22020-10-16Bumetanide Tablets, USP
63629-4968-32020-10-16Bumetanide Tablets, USP
63629-4968-42020-10-16Bumetanide Tablets, USP
63629-4968-12020-01-31Bumetanide Tablets, USP
63629-4968-22020-01-31Bumetanide Tablets, USP
63629-4968-32020-01-31Bumetanide Tablets, USP
63629-4968-42020-01-31Bumetanide Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-4968-1Bumetanide30 in 1 BOTTLETABLET301014
63629-4968-2Bumetanide90 in 1 BOTTLETABLET901014
63629-4968-3Bumetanide28 in 1 BOTTLETABLET281014
63629-4968-4Bumetanide18 in 1 BOTTLETABLET181014
63629-4968-5Bumetanide60 in 1 BOTTLETABLET601014
63629-4968-6Bumetanide100 in 1 BOTTLETABLET1001014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4968BUMETANIDE TABLET [BRYANT RANCH PREPACK]1014Current NDC, Legacy NDC, 6 package rows20240726_0fb6d547-9966-4352-8974-d02ea58e6445.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUMETANIDEACTIVE INGREDIENT0Y2S3XUQ5HBUMETANIDE TABLET [BRYANT RANCH PREPACK]1000
BUMETANIDEACTIVE MOIETY0Y2S3XUQ5HBUMETANIDE TABLET [BRYANT RANCH PREPACK]1000
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933BUMETANIDE TABLET [BRYANT RANCH PREPACK]1000
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBUMETANIDE TABLET [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUMETANIDE TABLET [BRYANT RANCH PREPACK]1000
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBUMETANIDE TABLET [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUMETANIDE TABLET [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBUMETANIDE TABLET [BRYANT RANCH PREPACK]1000
TALCINACTIVE INGREDIENT7SEV7J4R1UBUMETANIDE TABLET [BRYANT RANCH PREPACK]1000

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 5 · 81 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BumetanideBUMETANIDEREMEDYREPACK INC.de008936-e8a3-4e65-bb6a-d925b68a5f502026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197418
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEREMEDYREPACK INC.0fb78afc-d8bc-4ae8-8c0a-6d9c6f7a22c52026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074700
rxcui: 197419
unii: 0Y2S3XUQ5H
EnbumystBUMETANIDECorstasis USA LLCd6f752c5-d2bd-4f77-9611-ca2110066d1f2026-08-27Warnings, Adverse reactionsExact identifier
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDENorthStar Rx LLC551918e1-96c4-453a-870c-61b2828822062026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197419
rxcui: 197417
rxcui: 197418
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEMajor Pharmaceuticalsa29cf117-00d0-4948-b646-013c8791ea392026-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197418
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDESagent Pharmaceuticalsc38a404d-a919-4a2c-9fbb-d0655dee95162026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDECivica, Inc.4a9229c8-89ba-423e-8e36-f56bc329ed382026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEHikma Pharmaceuticals USA Inc.681b5e9d-e2c7-4f29-aaad-e06d4a528c112026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEAnthea Pharma Private Limited9058fc52-f3f6-4d7f-b2a0-b1e2c714b1332026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDECardinal Health 107, LLCe7c3c63e-3aea-4b33-b165-7c74493596742026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDESandoz Inc8914d8bf-61b7-4cd2-a8ef-7e1c5df378282026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074700
rxcui: 197419
rxcui: 197417
rxcui: 197418
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEA-S Medication Solutionsa4dd156d-0f17-43d9-bf78-2d358c50681b2026-05-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197418
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEBryant Ranch Prepack43ab2dd6-39ba-4a53-aa84-d7975038ef432026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEBryant Ranch Prepack37179b2d-6589-40d8-8121-7561a6791d382026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDECardinal Health 107, LLC0a5577f5-d2fe-4b0d-8245-78ee77df30fd2026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197418
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDECardinal Health 107, LLC9bd4fcd3-3020-41f2-b112-023b5db4487d2026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197418
unii: 0Y2S3XUQ5H
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
BumetanideBUMETANIDECardinal Health 107, LLC68f18d36-ffc2-4481-9286-914cfcf573a02026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEProficient Rx LP51d5f639-5d25-4ada-8bbe-ada2386173bf2026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197418
unii: 0Y2S3XUQ5H

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.