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 4 of 60 · 1,197 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: 451W47IQ8X
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55820ff9-7b4b-2bce-e063-6394a90a8b432026-06-30WarningsExact identifier
unii: 451W47IQ8X
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55806cb8-cf92-c4e5-e063-6394a90aaa2d2026-06-30WarningsExact identifier
unii: 451W47IQ8X
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC5581d8e5-4105-e9da-e063-6394a90a316e2026-06-30WarningsExact identifier
unii: 451W47IQ8X
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
MCAS SupportAPIS MELLIFICA, ANTIMONIUM CRUDUM, ASCORBICUM ACIDUM, BOVISTA, CARBOLICUM ACIDUM, CHAMOMILLA, CORTISONE ACETICUM, GINKGO BILOBA, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, QUERCETIN, RHUS TOX, SCUTELLARIA LATERIFLORA, STOMACH (SUIS), URTICA URENSDeseret Biologicals, Inc.af3d5f8f-6f24-4045-8730-c776ff54bcc42026-06-24WarningsExact identifier
unii: 451W47IQ8X
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
NitrogenNITROGENMaine Oxy-Acetylene Supply Company652ecc66-c6bb-40a3-a12f-64c7a4cdaca82026-06-18Exact identifier
unii: N762921K75
NitrogenNITROGENArcet Equipment Company dba Arc3 Gases Northff2ba9fb-e58a-4e57-8e96-b7e90cc6e2a82026-06-18Exact identifier
unii: N762921K75
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
0.9% Sodium Chloride Saline SolutionSODIUM CHLORIDEYunqi Cosmetics (Shenzhen) Co., Ltd546af257-dbd1-11fc-e063-6394a90a8e0a2026-06-16WarningsExact identifier
unii: 451W47IQ8X
BM BM68 DROPSARGENTUM NIT, BARYTA CARB., DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUMBM Private Limited53f9c99a-0f20-0358-e063-6394a90af4e02026-06-15WarningsExact identifier
unii: 451W47IQ8X
BM BM68ARGENTUM NIT, BARYTA CARB, DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro5448c76a-2ecb-9402-e063-6294a90a6ad72026-06-15WarningsExact identifier
unii: 451W47IQ8X
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro544b66c4-49df-556f-e063-6394a90af3ed2026-06-15WarningsExact identifier
unii: 451W47IQ8X
NITROGEN Compressed, NFNITROGENAIRGAS USA, LLC6638a09f-7d87-48ce-934b-5edb3891ad612026-06-15Exact identifier
unii: N762921K75
Male SupportAGNUS CASTUS, AURUM METALLICUM, BENZOICUM ACIDUM, BRYONIA (ALBA), BUFO RANA, CALADIUM SEGUINUM, CHIMAPHILA UMBELLATA, CLEMATIS ERECTA, CONIUM MACULATUM, CORTISONE ACETICUM, HYPOTHALAMUS SUIS, KALI ARSENICOSUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PROSTATE (SUIS), RHODODENDRON CHRYSANTHUM, SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, TESTOSTERONE, THUJA OCCIDENTALISDeseret Biologicals, Inc.29cefc89-3bb6-484e-84ab-116b5827a4c32026-06-15WarningsExact identifier
unii: 451W47IQ8X
Nitrogen, RefrigeratedNITROGEN, REFRIGERATEDAirgas Usa, LLC9c536407-8936-4a32-91c2-22712ae2c1f22026-06-15Exact identifier
unii: N762921K75
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDTotal Operations Management LLC DBA:Bestmade Natural Products Micro5423bde6-3e31-38b0-e063-6294a90afb2d2026-06-13WarningsExact identifier
unii: QTT17582CB
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDBM Private Limited540d11e3-e4a1-0ca2-e063-6394a90a3c262026-06-12WarningsExact identifier
unii: QTT17582CB

Reported adverse events (FAERS/openFDA)#

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