FDA.reportPublic FDA data

NDC 65862-944-05 - Levalbuterol

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
65862-944
Requested NDC
65862-944-05
Package NDCs from labels
65862-944-05, 65862-944-25
Manufacturer
Aurobindo Pharma Limited | Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.
Effective date
2024-12-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LevalbuterolAurobindo Pharma Limited | Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.2024-12-24HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-944-05Levalbuterol3 mL in 1 VIAL, SINGLE-DOSESOLUTION38
65862-944-05Levalbuterol5 in 1 POUCHSOLUTION58
65862-944-25Levalbuterol5 in 1 CARTONSOLUTION58

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-944LEVALBUTEROL SOLUTION [AUROBINDO PHARMA LIMITED]8Current NDC, Legacy NDC, 3 package rows20241226_5f1c4f22-d420-495c-8f64-33532638215f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-944-12ML - Milliliter65862-944259b1cc2-08ff-4309-94d9-037200d4521b12018-01-12
65862-944-24ML - Milliliter65862-94486470ed1-7955-436e-9877-32bf8596c20c12018-01-12

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 33 of 59 · 1,173 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NITROGENNITROGENAir Liquide Large Industries U.S. LPf49fbee2-8a80-477a-969b-f891ee601dc32025-01-16Exact identifier
unii: N762921K75
Sodium Chloride Hypertonicity Ophthalmic Solution, 5%SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC SOLUTION, 5%Reliable 1 Laboritories LLC29175c17-223e-5e92-e063-6294a90a71d22025-01-15WarningsExact identifier
unii: 451W47IQ8X
D-28CLAVICEPS PURPUREA SCLEROTIUM, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, SAFFRON, FERROSOFERRIC PHOSPHATE, SULFURIC ACID, AND HORSE CHESTNUTDNA Labs, Inc.2e75490a-b63d-419b-8e33-72e30faea4502025-01-13WarningsExact identifier
unii: O40UQP6WCF
D-10SEPIA OFFICINALIS WHOLE, SANGUINARIA CANADENSIS ROOT, SULFURIC ACID, BLACK COHOSH, AND LACHESIS MUTA VENOMDNA Labs, Inc.1e5ba502-eef4-4df0-8330-b70d1872b4bb2025-01-13WarningsExact identifier
unii: O40UQP6WCF
D-43ARSENIC TRIOXIDE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, ACTIVATED CHARCOAL, BOS TAURUS PITUITARY GLAND, POSTERIOR, SODIUM SULFATE, VERATRUM ALBUM ROOT, ERIODICTYON CALIFORNICUM LEAF, SODIUM CHLORIDE, AND DIBASIC POTASSIUM PHOSPHATEDNA Labs, Inc.937e2b7e-4001-402f-bd12-dcff4627e9282025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-78HYPERICUM PERFORATUM, LACHESIS MUTA VENOM, LYTTA VESICATORIA, ECHINACEA ANGUSTIFOLIA, SODIUM CHLORIDE, AND PLANTAGO MAJORDNA Labs, Inc.d62673a9-8a67-4580-a8bf-25f85960a5552025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-86ARNICA MONTANA, SILICON DIOXIDE, SODIUM CHLORIDE, LEAD ACETATE ANHYDROUS, SELENICEREUS GRANDIFLORUS STEM, TRIBASIC CALCIUM PHOSPHATE, AND POTASSIUM IODIDEDNA Labs, Inc.54fa62d3-c129-4826-a794-f3dcc6b855bf2025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-98STRYCHNOS NUX-VOMICA SEED, MATRICARIA CHAMOMILLA, ANEMONE PRATENSIS, SODIUM CHLORIDE, CALCIUM SULFIDE, GOLD, DAPHNE MEZEREUM BARK, PLATINUM, AND BERBERIS VULGARIS ROOT BARKDNA Labs, Inc.9b39b277-9eb2-44c9-9c0c-a8680a50e18d2025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-129SODIUM CHLORIDEDNA Labs, Inc.ef130f08-1c34-4774-9298-2d1997e631fc2025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-50HORSE CHESTNUT, CITRULLUS COLOCYNTHIS FRUIT PULP, BLACK COHOSH, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, AND STRONTIUM CARBONATEDNA Labs, Inc.df118b9b-dee7-4555-bcae-751007c1fd2c2025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-68CROTON OIL, DAPHNE MEZEREUM BARK, SODIUM CHLORIDE, AND TOXICODENDRON PUBESCENS LEAFDNA Labs, Inc.01ae098b-aadd-4edc-bf73-6bc60903e7792025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-53AMMONIUM BROMIDE, BROMINE, CALCIUM SULFIDE, POTASSIUM BROMIDE, RHODODENDRON TOMENTOSUM LEAFY TWIG, SODIUM BROMIDE, SODIUM CHLORIDE, AND BOS TAURUS PLACENTADNA Labs, Inc.3787d569-ee4d-41de-9519-73c11b626b382025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-51ATROPA BELLADONNA, IODINE, LYCOPUS VIRGINICUS, SODIUM CHLORIDE, HEKLA LAVA, AND CALCIUM HEXAFLUOROSILICATEDNA Labs, Inc.9928dd54-bd3a-47cb-bde5-4bebab3db6832025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-112LACHESIS MUTA VENOM, SILICON DIOXIDE, SODIUM CHLORIDE, RANUNCULUS BULBOSUS, ACONITUM NAPELLUS, ACTIVATED CHARCOAL, NITROGLYCERIN, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ANEMONE PRATENSIS, PLANTAGO MAJOR, ARSENIC TRIOXIDE, AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEDNA Labs, Inc.8d517ef2-3a1e-4393-9452-a4cd0f0a3bca2025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-65ARSENIC TRIOXIDE, BERBERIS AQUIFOLIUM ROOT BARK, OYSTER SHELL CALCIUM CARBONATE, CRUDE, GRAPHITE, CENTELLA ASIATICA, AND SODIUM CHLORIDEDNA Labs, Inc.94d4b66a-f995-4516-bdcf-2152c2a624dd2025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-88COCCULUS INDICUS, NATRUM MURIATICUM, HELONIAS DIOICA, CALCAREA PHOSPHORICUM, IGNATIA AMARA, MAGNESIA PHOSPHORICUM, CIMICIFUGA RACEMOSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, SEPIA, KALIUM PHOSPHORICUM, ZINCUM METALLICUM, PITUITARY, ADRENAL, OVARIANDNA Labs, Inc.1eefff9c-d86c-44ef-b968-9a8c5a9c54032025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-73SULFURIC ACID, SILVER, ARNICA MONTANA, BRYONIA ALBA ROOT, CAUSTICUM, AND RHODODENDRON TOMENTOSUM LEAFY TWIGDNA Labs, Inc.46fe6da9-404b-4f73-8fe8-c48c5e028ffe2025-01-13WarningsExact identifier
unii: O40UQP6WCF
D-115CAUSTICUM, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, IODINE, ARSENIC TRIOXIDE, BARIUM CARBONATE, ECHINACEA ANGUSTIFOLIA, ALUMINUM, ANTIMONY TRISULFIDE, STRYCHNOS NUX-VOMICA SEED, DELPHINIUM STAPHISAGRIA SEED, SULFURIC ACID, CALCIUM SULFIDE, AND SILVER NITRATEDNA Labs, Inc.247a9133-fe4b-42a0-b3f3-7cb62eaec8c42025-01-13WarningsExact identifier
unii: O40UQP6WCF
D-133CALCIUM FLUORIDE, SILICON DIOXIDE, TRIBASIC CALCIUM PHOSPHATE, CALCIUM SULFATE ANHYDROUS, FERROSOFERRIC PHOSPHATE, POTASSIUM CHLORIDE, DIBASIC POTASSIUM PHOSPHATE, POTASSIUM SULFATE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM CHLORIDE, AND SODIUM SULFATEDNA Labs, Inc.a250b7e9-7fd2-4cb0-82f3-baa089d174412025-01-13WarningsExact identifier
unii: 451W47IQ8X
Premixed saline packetsSODIUM CHLORIDE, SODIUM BICARBONATEShenzhen Kerui lntl Trading Co., Ltd0d11e07b-c137-6efc-e063-6394a90a6bba2025-01-09WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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