FDA.reportPublic FDA data

NDC 17478-171-01 - Xopenex

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
17478-171
Requested NDC
17478-171-01
Package NDCs from labels
17478-171-01, 17478-171-30
Manufacturer
Akorn
Effective date
2022-09-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Xopenex - AkornAkorn2022-09-14HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17478-171-302024-01-30C16284748780-11030e365-13cf-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use XOPENEX ® Inhalation Solution Concentrate safely and effectively. See full prescribing information for XOPENEX ® Inhalation Solution Concentrate. XOPENEX ® (levalbuterol hydrochloride) Inhalation Solution Concentrate Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17478-171-01Xopenex1 in 1 POUCHSOLUTION, CONCENTRATE18
17478-171-01Xopenex0.5 mL in 1 VIAL, SINGLE-DOSESOLUTION, CONCENTRATE0.58
17478-171-30Xopenex30 in 1 CARTONSOLUTION, CONCENTRATE308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17478-171XOPENEX (LEVALBUTEROL HYDROCHLORIDE) SOLUTION, CONCENTRATE [AKORN]8Legacy NDC, 3 package rows20220919_0c47c47d-45f7-4eb4-b1f8-7d6c633a1f69.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-171-01EA - Each17478-171390bae5f-4282-42f2-b603-65a8ec82edf212015-07-20
17478-171-30EA - Each17478-1716ea051d3-4d2f-4025-bb8f-b50a5da7154e12015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Levalbuterol HydrochlorideACTIVE INGREDIENTWDQ1526QJMXOPENEX (LEVALBUTEROL HYDROCHLORIDE) SOLUTION, CONCENTRATE [AKORN, INC.]1
LevalbuterolACTIVE MOIETYEDN2NBH5SSXOPENEX (LEVALBUTEROL HYDROCHLORIDE) SOLUTION, CONCENTRATE [AKORN, INC.]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBXOPENEX (LEVALBUTEROL HYDROCHLORIDE) SOLUTION, CONCENTRATE [AKORN, INC.]1
NitrogenINACTIVE INGREDIENTN762921K75XOPENEX (LEVALBUTEROL HYDROCHLORIDE) SOLUTION, CONCENTRATE [AKORN, INC.]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XXOPENEX (LEVALBUTEROL HYDROCHLORIDE) SOLUTION, CONCENTRATE [AKORN, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RXOPENEX (LEVALBUTEROL HYDROCHLORIDE) SOLUTION, CONCENTRATE [AKORN, INC.]1

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 6 of 57 · 1,140 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEHospira, Inc.a2a964f7-c3ec-4dfb-e3a0-6d8136a803972026-05-19Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643bc58-bb0e-5c79-e053-2991aa0a02ae2026-05-19WarningsExact identifier
unii: QTT17582CB
HerplexANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIANashco Products LLCe5e7aa2f-3697-4747-9045-670ea2b135572026-05-14WarningsExact identifier
unii: 451W47IQ8X
NebuClear MDSALINEBlue Echo Care LLC3f85fe62-230f-b0f1-e063-6394a90a5cb82026-05-11WarningsExact identifier
unii: 451W47IQ8X
NitrogenNITROGENUCG Georgia, LLC7b077025-c8f6-2790-e053-2991aa0aa9c22026-05-11Exact identifier
unii: N762921K75
Acne ReliefBELLADONNA, SILICEA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, KALI BROMATUM, LEDUM PALUSTRE, NATRUM MURIATICUM, SELENIUM, SULPHURNaturalCare487b1373-b78c-4510-964a-6ab0fe781ff42026-05-08WarningsExact identifier
unii: 451W47IQ8X
Migraine ReliefBELLADONNA, BRYONIA (ALBA), CHAMOMILLA, CIMICIFUGA RACEMOSA, COFFEA CRUDA, GLONOINUM, IRIS VERSICOLOR, NATRUM MURIATICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALISThe Magni Company79b25c52-e145-4ee5-af2e-1ccf6ad5ac2d2026-05-07WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
VirilBENZOICUM ACIDUM, CALADIUM SEGUINUM, CHIMAPHILA UMBELLATA, CLEMATIS ERECTA, RHODODENDRON, SABAL SERRULATA, NATRUM MURIATICUM, CORTISONE ACETICUM, HYPOTHALAMUS SUIS, PROSTATE (SUIS), TESTOSTERONE, AGNUS CASTUS, AURUM METALLICUM, BRYONIA (ALBA), CONIUM MACULATUM, LYCOPODIUM CLAVATUM, SELENIUM METALLICUM, SEPIA, THUJA OCCIDENTALIS, KALI ARSENICOSUM, BUFO RANADeseret Biologicals, Inc.3701cc0d-91ed-45fd-98b8-9d8cfba9c7872026-05-06WarningsExact identifier
unii: 451W47IQ8X
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
NitrogenNITROGENWELDERS SUPPLY COMPANY OF LOUISVILLE, INC.1017e562-498d-9554-e063-6394a90ab5662026-04-28Exact identifier
unii: N762921K75
nitrogenNITROGENGeneral Welding Supply Corp.eac79df6-5725-4ff1-9b62-c74453d231062026-04-28Exact identifier
unii: N762921K75
Sodium ChlorideSODIUM CHLORIDESportpharm LLCa2c111f6-74d5-4a5d-82ac-d0f237488cb82026-04-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEMethod Pharmaceuticals, LLC4b08859e-65bd-8255-e063-6394a90af6142026-04-23WarningsExact identifier
unii: 451W47IQ8X
NitrogenNITROGENAtlas Welding Supply Company, Inc.7e0e5e70-74c7-4916-a7cd-dd6676d084ab2026-04-21Exact identifier
unii: N762921K75
NitrogenNITROGENLinde Gas & Equipment Inc.2fb2a326-a9b4-4cbc-83c0-e5fa041be1f02026-04-20Exact identifier
unii: N762921K75
RingersSODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEICU Medical, Inc.a926f913-18fa-4a3e-bfd6-210e1e4279602026-04-20Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Cardioforce IIABROTANUM, BOLDO, CIMICIFUGA RACEMOSA, KALI PHOSPHORICUM, TARAXACUM OFFICINALE, CONVALLARIA MAJALIS, MAGNESIA SULPHURICA, OLEANDER, NATRUM MURIATICUM, BELLIS PERENNISBioActive Nutritional, Inc.733bbb26-7698-4a1b-9dc8-7e3490ffc92b2026-04-17WarningsExact identifier
unii: 451W47IQ8X
Thyroid HPBARYTA CARBONICA, CALCAREA CARBONICA, FUCUS VESICULOSUS, IODIUM, NATRUM MURIATICUM, PULSATILLA, SPONGIA TOSTA, THYROIDINUM (SUIS)BioActive Nutritional, Inc.3795820a-cf2a-4094-9a02-70e3757b75102026-04-17WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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