FDA.reportPublic FDA data

NDC 83301-0081-1 - 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
83301-0081
Requested NDC
83301-0081-1
Package NDCs from labels
83301-0081-1, 83301-0081-2
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
83301-0081-1Bumetanide10 mL in 1 VIAL, MULTI-DOSEINJECTION103
83301-0081-2Bumetanide10 in 1 CARTONINJECTION103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83301-0081BUMETANIDE 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
83301-0081-1ML - Milliliter83301-008120980ac0-509c-4314-b2f0-46bd967701cb12026-02-05
83301-0081-2ML - Milliliter83301-00819e1a9585-2c5a-4ec8-bc22-30f3a98d9c6412025-09-12

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 30 of 54 · 1,066 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
N-16MGO ENERGIZERDNA Labs, Inc.8292b900-86c1-47ea-81da-b587439c76642025-01-09WarningsExact identifier
unii: 451W47IQ8X
N-21CALCIUM FLUORIDE, SILICON DIOXIDE, EUPHRASIA STRICTA, RUTA GRAVEOLENS WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, PHYSOSTIGMA VENENOSUM WHOLE, ANEMONE PULSATILLA, SODIUM CHLORIDE, AND SUS SCROFA EYEDNA Labs, Inc.89967941-c4ee-4598-a66d-8a93d69a4d652025-01-09WarningsExact identifier
unii: 451W47IQ8X
N-14FUCUS VESICULOSUS, SODIUM CHLORIDE, LYCOPUS VIRGINICUS, SPONGIA OFFICINALIS SKELETON, ROASTED, POTASSIUM IODIDE, CALCIUM IODIDE, THYROID, UNSPECIFIED, BOS TAURUS ADRENAL GLAND, BOS TAURUS PITUITARY GLAND, POSTERIOR, BOS TAURUS THYMUS, AND SUS SCROFA SPLEENDNA Labs, Inc.3d64739c-5d61-4e88-8612-d5f6994f1c3c2025-01-09WarningsExact identifier
unii: 451W47IQ8X
N-24METABOLINDNA Labs, Inc.559fca2b-1093-4bdf-be70-c453f87002c32025-01-09WarningsExact identifier
unii: 451W47IQ8X
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R
BUMETANIDEBUMETANIDEHF Acquisition Co LLC, DBA HealthFirst9bd7a71e-0e78-dae7-e053-2995a90ad1102025-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1727569
unii: 0Y2S3XUQ5H
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
0.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst8dfb05c0-77e8-2fa1-e053-2a95a90a3d332025-01-08Adverse reactionsExact identifier
unii: 451W47IQ8X
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst998a2a47-5c79-2efd-e053-2995a90a8fac2025-01-08Adverse reactionsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst7da788fc-3481-527f-e053-2a91aa0af6ac2025-01-08Adverse reactionsExact identifier
unii: 451W47IQ8X
BumetanideBUMETANIDEBryant Ranch Prepack056be255-5880-48e9-b160-bd5b3d82c24a2025-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEBryant Ranch Prepack80fe034e-01b7-438e-8378-44fafb7a1d942025-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0Y2S3XUQ5H
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEBECTON DICKINSON AND COMPANYc1d0f42e-3494-4217-8f86-e9f34d930e822025-01-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.a480e5f4-5f9e-4b23-b257-b0ac1ebfc1152025-01-07WarningsExact identifier
unii: LKG8494WBH
Shingles RemedyCROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLASilver Star Brands5d65c997-f5dc-4dee-e053-2a91aa0ac3192025-01-01WarningsExact identifier
unii: 451W47IQ8X
Mucus Clear Allergy ReliefALLIU CEPA, CALC PHOS, EUPHRASIA, IGNATIA, KALI MUR, NAT MUR, NUX VOM, PULSATILLA, SILICASilver Star Brandsf49bdcc1-1939-6dc2-e053-2995a90a0a3b2025-01-01WarningsExact identifier
unii: 451W47IQ8X
Sweat-LessARG NIT, CASTOREUM, HUMULUS, IODUM, KALI PHOS, NAT MURSilver Star Brands4053d10b-4b06-291b-e054-00144ff88e882025-01-01WarningsExact identifier
unii: 451W47IQ8X
NativeRemedies Triple Complex Brain TonicCALC PHOS, KALI PHOS, NAT MUR.Silver Star Brandsf76eaf46-4a80-31a9-e053-6394a90a542d2025-01-01WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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