FDA.reportPublic FDA data

NDC 83301-0080-01 - 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
83301-0080
Requested NDC
83301-0080-01
Package NDCs from labels
83301-0080-1, 83301-0080-2, 83301-0080-01
Manufacturer
Mullan Pharmaceutical Inc. | Qilu Pharmaceutical (Hainan) Co., Ltd
Effective date
2026-03-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Bumetanide - Mullan Pharmaceutical Inc. | Qilu Pharmaceutical (Hainan) Co., LtdMullan Pharmaceutical Inc. | Qilu Pharmaceutical (Hainan) Co., Ltd2026-03-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83301-0080-1Bumetanide4 mL in 1 VIAL, SINGLE-DOSEINJECTION43
83301-0080-2Bumetanide10 in 1 CARTONINJECTION103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83301-0080BUMETANIDE INJECTION [MULLAN PHARMACEUTICAL INC.]1Current NDC, 2 package rows20250425_b7cd724b-817b-4b45-8133-1ebf505867e7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83301-0080-1ML - Milliliter83301-0080b773d63b-a91a-4d30-b612-8078fef2e82412026-02-05
83301-0080-2ML - Milliliter83301-0080835a88a2-f52d-4f42-b7eb-2bc756618cf512025-07-08

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 26 of 56 · 1,116 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sinus Wash PacketSODIUM BICARBONATE, SODIUM CHLORIDEBETTER LIVING BRANDS LLC33ee7b77-0871-4df8-e063-6394a90ac4792025-04-29WarningsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLC6d43fa91-0940-437f-ba70-b2d3f977593e2025-04-25Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
BumetanideBUMETANIDECamber Pharmaceuticals, Inc.084b34ad-36ba-43bd-a43a-1f4b4da26d8f2025-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1727569
rxcui: 282486
unii: 0Y2S3XUQ5H
Nat Mur 6XSODIUM CHLORIDEHyland's Inc.dcf0e2ac-3b69-3ae4-e053-2a95a90aaf412025-04-10WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM68 PelletsPHOSPHORUS, ARG NIT, GELSEMIUM, NAT MUR, KALI BROM, BARYTA CARBBestmade Natural Products32423a04-31d1-7477-e063-6394a90aecac2025-04-08WarningsExact identifier
unii: 451W47IQ8X
BumetanideBUMETANIDELifestar Pharma LLC51a344b6-acf9-4ac4-b743-1e63e3df79582025-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0Y2S3XUQ5H
Bestmade Natural Products Nat Mur 8xNATRUM MURIATICUMBestmade Natural Products31e0e16d-e4df-cd9a-e063-6394a90abcc12025-04-03WarningsExact identifier
unii: 451W47IQ8X
BumetanideBUMETANIDEHikma Pharmaceuticals USA Inc.b5a68154-8003-4b80-81e2-e926524fb72c2025-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1727569
rxcui: 282486
unii: 0Y2S3XUQ5H
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
Kidneyforce-HPARNICA MONTANA, AURUM METALLICUM, CACTUS GRANDIFLORUS, CALCAREA CARBONICA, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, SOLIDAGO VIRGAUREABioActive Nutritional, Inc.0c0f0c0c-10c2-47eb-aad6-bbffb6e167992025-04-02WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDE TABLETBelleview Bioscience LLC31195e8f-d4de-9e37-e063-6294a90a41562025-03-24WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO13 Lactose FreeCALC PHOS KALI SULPH, KALI PHOS, NAT MURBestmade Natural Products303590c5-8a66-aafc-e063-6294a90a1a4e2025-03-23WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO13CALC PHOS, KALI SULPH, KALI PHOS, NAT MURBestmade Natural Products2fffab7f-0d4b-0e96-e063-6294a90a34d82025-03-23WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Nat MurNAT MURBestmade Natural Productse9e9a4f6-5104-3c6f-e053-2995a90a11652025-03-21WarningsExact identifier
unii: 451W47IQ8X
Pituitary LiquescenceCAULOPHYLLUM THALICTROIDES, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, PINEAL GLAND (SUIS), CIMICIFUGA RACEMOSA, NATRUM MURIATICUM, CINCHONA OFFICINALIS, ADRENOCORTICOTROPHINNutritional Specialties, Inc.292ca967-abe8-4ae1-b2fe-942531a1e14a2025-03-20WarningsExact identifier
unii: 451W47IQ8X
Anxiety HPACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, CALCAREA CARBONICA, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), STAPHYSAGRIA, STRAMONIUMEnergique, Inc.191393fa-5f36-43c0-a183-09258eef9bda2025-03-20WarningsExact identifier
unii: 451W47IQ8X
HYDRA NEBSODIUM CHLORIDEVenture Healthcare Ltd30b184bf-2451-d96b-e063-6294a90a43c72025-03-19WarningsExact identifier
unii: 451W47IQ8X
HYDRA NEBSODIUM CHLORIDELaboratoire Unither30b244c0-84bb-a0a0-e063-6394a90a9dee2025-03-19WarningsExact identifier
unii: 451W47IQ8X
BumetanideBUMETANIDEQilu Pharmaceutical Co., Ltd.ef5fe12a-f8ee-4ba7-932b-51bbaccf65752025-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA219116
rxcui: 1727569
rxcui: 282486
unii: 0Y2S3XUQ5H
Bestmade Natural Products BIO16 Lactose FreeCALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MURBestmade Natural Products3036922b-0f2c-12ff-e063-6394a90a85782025-03-13WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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