FDA.reportPublic FDA data

NDC 70518-4387-00 - 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
70518-4387
Requested NDC
70518-4387-00
Package NDCs from labels
70518-4387-0, 70518-4387-00
Manufacturer
REMEDYREPACK INC.
Effective date
2025-07-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Bumetanide Tablets, USPREMEDYREPACK INC.2025-07-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4387-0Bumetanide90 in 1 BOTTLE, PLASTICTABLET901

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 8 · 147 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
unii: 1K09F3G675
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
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
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYTarget Corporation36602b7a-99c0-f6a4-e063-6294a90a87582026-06-29WarningsExact identifier
unii: 1K09F3G675
CalaSootheCALAMINE, MENTHOL, AND ZINC OXIDEDynarex Corporation54f12005-acfe-4821-e063-6394a90ac3042026-06-24WarningsExact identifier
unii: 1K09F3G675
Calamine, Pramoxind HClCALAMINE, PRAMOXIND HCLH E B4a7a0b09-d9bc-e752-e063-6394a90a9f2c2026-06-15Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Calamine, Zinc OxideCALAMINE, ZINC OXIDEH E B4a79259e-64ac-d187-e063-6294a90a78db2026-06-15Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
BumetanideBUMETANIDESandoz Inc8914d8bf-61b7-4cd2-a8ef-7e1c5df378282026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074700
rxcui: 197419
rxcui: 197417
rxcui: 197418
unii: 0Y2S3XUQ5H
CalamineCALAMINE AND ZINC OXIDEPharma Nobis, LLCfbcfa541-beda-06de-e053-6294a90a92982026-05-26WarningsExact identifier
unii: 1K09F3G675
BumetanideBUMETANIDEA-S Medication Solutionsa4dd156d-0f17-43d9-bf78-2d358c50681b2026-05-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197418
unii: 0Y2S3XUQ5H
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYCVS Pharmacydb6f518d-3a0e-43f8-8d19-7382d9b7ff1c2026-05-11WarningsExact identifier
unii: 1K09F3G675
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
CalamineFERRIC OXIDE REDRetail Business Services, LLC7291e175-a9b6-4c47-93ce-227ce11e45992026-04-30Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
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