FDA.reportPublic FDA data

NDC 27437-106-02 - Alinia

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
27437-106
Requested NDC
27437-106-02
Package NDCs from labels
27437-106-01, 27437-106-02
Manufacturer
LUPIN PHARMACEUTICALS, INC.
Effective date
2024-03-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Alinia - LUPIN PHARMACEUTICALS, INC.LUPIN PHARMACEUTICALS, INC.2024-03-20HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
27437-106-012025-07-29C16284748780-13b156c62-2cb5-fb37-e063-e6dba90a4e07These highlights do not include all the information needed to use ALINIA safely and effectively. See full prescribing information for ALINIA. ALINIA® (nitazoxanide) tablets, for oral use ALINIA® (nitazoxanide) for oral suspension Initial U.S. Approval: 2002
27437-106-022025-07-29C16284748780-13b156c62-2cb5-fb37-e063-e6dba90a4e07These highlights do not include all the information needed to use ALINIA safely and effectively. See full prescribing information for ALINIA. ALINIA® (nitazoxanide) tablets, for oral use ALINIA® (nitazoxanide) for oral suspension Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27437-106-01Alinia60 mL in 1 BOTTLE, GLASSPOWDER, FOR SUSPENSION6010
27437-106-01Alinia1 in 1 CARTONPOWDER, FOR SUSPENSION110
27437-106-02Alinia1 in 1 CARTONPOWDER, FOR SUSPENSION110
27437-106-02Alinia60 mL in 1 BOTTLE, GLASSPOWDER, FOR SUSPENSION6010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27437-106ALINIA (NITAZOXANIDE) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]104 package rows20240322_e90f98d9-3c9b-4e75-ba18-5517283eadf0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27437-106-01ML - Milliliter27437-10674d0a432-b5b6-49f1-85d5-e1011203a46112013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
nitazoxanideACTIVE INGREDIENTSOA12P041NALINIA (NITAZOXANIDE) POWDER, FOR SUSPENSION [LUPIN PHARMA]3
nitazoxanideACTIVE MOIETYSOA12P041NALINIA (NITAZOXANIDE) POWDER, FOR SUSPENSION [LUPIN PHARMA]3
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLALINIA (NITAZOXANIDE) POWDER, FOR SUSPENSION [LUPIN PHARMA]3
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS311ALINIA (NITAZOXANIDE) POWDER, FOR SUSPENSION [LUPIN PHARMA]3
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UALINIA (NITAZOXANIDE) POWDER, FOR SUSPENSION [LUPIN PHARMA]3
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOAALINIA (NITAZOXANIDE) POWDER, FOR SUSPENSION [LUPIN PHARMA]3
maltodextrinINACTIVE INGREDIENT7CVR7L4A2DALINIA (NITAZOXANIDE) POWDER, FOR SUSPENSION [LUPIN PHARMA]3
modified corn starch (1-octenyl succinic anhydride)INACTIVE INGREDIENT461P5CJN6TALINIA (NITAZOXANIDE) POWDER, FOR SUSPENSION [LUPIN PHARMA]3
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUALINIA (NITAZOXANIDE) POWDER, FOR SUSPENSION [LUPIN PHARMA]3
sucroseINACTIVE INGREDIENTC151H8M554ALINIA (NITAZOXANIDE) POWDER, FOR SUSPENSION [LUPIN PHARMA]3
triacetinINACTIVE INGREDIENTXHX3C3X673ALINIA (NITAZOXANIDE) POWDER, FOR SUSPENSION [LUPIN PHARMA]3
trisodium citrate dihydrateINACTIVE INGREDIENTB22547B95KALINIA (NITAZOXANIDE) POWDER, FOR SUSPENSION [LUPIN PHARMA]3
xanthan gumINACTIVE INGREDIENTTTV12P4NEEALINIA (NITAZOXANIDE) POWDER, FOR SUSPENSION [LUPIN PHARMA]3

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 1 of 15 · 286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheraTearsCARBOXYMETHYLCELLULOSE SODIUMMEDTECH PRODUCTS INC17a01236-130f-495b-9f8d-92b6a23b2dc52026-09-09WarningsExact identifier
unii: K679OBS311
REFRESH LIQUIGELCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.4b8b2f6a-4b89-446c-9e5b-9b83c453a01d2026-08-28WarningsExact identifier
unii: K679OBS311
CVS Health Nausea ReliefSODIUM CITRATE DIHYDRATECVS PHARMACY,INC.a5f9de6f-70d8-4bb0-8a5b-3dd120df29902026-08-14WarningsExact identifier
unii: B22547B95K
AdaptopathADENOSINUM CYCLOPHOSPHORICUM, ALPHA-LIPOICUM ACIDUM, ARGENTUM METALLICUM, AVENA SATIVA, CAPSICUM ANNUUM, CITRICUM ACIDUM, COENZYME A, CUPRUM METALLICUM, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYPOTHALAMUS (BOVINE), IODIUM, LEDUM PALUSTRE, MANGANUM ACETICUM, NADIDUM, NATRUM CARBONICUM, OLEUM MORRHUAE, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, RIBOFLAVINUM, SELENIUM METALLICUM SEPIA, SILICEA, THIAMINUM HYDROCHLORICUM, THYROIDINUM (BOVINE), VANADIUM METALLICUMEnergetix Corporation41234598-0cb5-41c2-bfbe-1c15ee9bf5022026-08-11WarningsExact identifier
unii: XF417D3PSL
Aller-Chord AALFALFA, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, BRYONIA (ALBA), CITRICUM ACIDUM, COUMARINUM, EUPHRASIA OFFICINALIS, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, JUNIPERUS COMMUNIS, MUCOSA NASALIS SUIS, NATRUM SULPHURICUM, PHOSPHORUS, POTHOS FOETIDUS, PULSATILLA (VULGARIS), SOLIDAGO VIRGAUREA, SULPHUR, TANACETUM VULGARE, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSEEnergetix Corporation09e89c92-112d-4320-9df5-b9f938bb90952026-08-11WarningsExact identifier
unii: XF417D3PSL
Hepatic-ToneCARDUUS MARIANUS, CEANOTHUS AMERICANUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CITRICUM ACIDUM, CYSTEINUM, HEPAR SUIS, LEPTANDRA VIRGINICA, MAGNESIA MURIATICA, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, QUASSIA (AMARA), TARAXACUM OFFICINALEEnergetix Corporationd5f61f13-7e9f-4e46-8ad8-0336f36288df2026-08-11WarningsExact identifier
unii: XF417D3PSL
Isopathic Phenolic RingsHOMEOPATHIC LIQUIDEnergetix Corporation98a7ca26-ccb7-43c7-bd65-892fcbacc8822026-08-11WarningsExact identifier
unii: C151H8M554
unii: XF417D3PSL
Lipo-ChordACETICUM AC, ACETYLSAL AC, ADRENOCORTICOTROPHIN, ALUMINA, ARSENICUM ALB, BORAGO, CEANOTHUS, CHELIDONIUM MAJ, CHIONANTHUS, CHLORAMPHENICOLUM, CHLORPROMAZINUM, CHOLESTERINUM, CORTISONE ACETICUM, DAMIANA, FOLLICULINUM, FUMARICUM AC, KALI IOD, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, OLEUM MORRHUAE, PETROLEUM, PHENACETINUM, PHOSPHORICUM AC, PHOSPHORUS, PLUMB MET, SACCHARUM OFF, SILICEA, TARAXACUM, THYROIDINUM.Energetix Corporation5c83cbd5-46fb-48a0-a739-ff9c81e7129c2026-08-11WarningsExact identifier
unii: C151H8M554
MetabopathADENOSINUM CYCLOPHOSPHORICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, BERBERIS VULGARIS, CITRICUM ACIDUM, COENZYME A, DNA, FUMARICUM ACIDUM, GLYCYRRHIZA GLABRA, HEPAR SULPHURIS CALCAREUM, LAPPA MAJOR, MAGNESIA PHOSPHORICA, MANGANUM ACETICUM, NADIDUM, NATRUM MURIATICUM, NATRUM OXALACETICUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PULSATILLA, PYRIDOXINUM HYDROCHLORICUM, RHAMNUS PURSHIANA, RIBOFLAVINUM, RNA, SILICEA, SUCCINICUM ACIDUM, SULPHUR, THIAMINUM HYDROCHLORICUM,Energetix Corporation58bfe670-d308-45a2-8046-7897b62214522026-08-11WarningsExact identifier
unii: XF417D3PSL
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: K679OBS311
XenletaLEFAMULIN ACETATEMeitheal Pharmaceuticals Inc.eb972ea8-7502-422e-84bb-66cb8e93ca062026-07-22Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
Retaine CMCCARBOXYMETHYLCELLULOSE SODIUMOCuSOFT LLCa3698c71-0c80-4246-be52-5e7d96f6c5402026-07-06WarningsExact identifier
unii: K679OBS311
SET 4TE HOMOADEPS SUILLUS, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CHOLINUM, DNA, DOPAMINE (HYDROCHLORIDE), FERRUM PHOSPHORICUM, FOLIC ACID, INSULINUM (HUMAN), LEPTIN, MAGNESIA MURIATICA, L-METHIONINE, METHYLCOBALAMIN, PROTEUS (VULGARIS), RHUS TOX, RIBOFLAVINUM, RUTA GRAVEOLENS, SACCHARUM OFFICINALE, THIOSINAMINUM, ZINCUM METALLICUMDeseret Biologicals, Inc.e7b8d75b-f2bc-4013-91e7-bf5bbec11a902026-06-25WarningsExact identifier
unii: C151H8M554
NitazoxanideNITAZOXANIDEe5 Pharma, LLC40a7cc30-76cd-49fe-965a-7823c4140d0f2026-06-18Adverse reactionsExact identifier
unii: SOA12P041N
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: XF417D3PSL
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd.395aec48-198a-4aed-8e38-7accfb3232f92026-06-15Warnings, Adverse reactionsExact identifier
unii: B22547B95K
Lubricant EyeCARBOXYMETHYLCELLULOSE SODIUM 0.5%CARDINAL HEALTH 110, LLC. DBA LEADER51a2d74f-5ff3-9921-e063-6294a90a345a2026-06-15WarningsExact identifier
unii: K679OBS311
Lubricant EyeCARBOXYMETHYLCELLULOSE SODIUMRugby Laboratories51cadca6-a31b-c1b5-e063-6394a90a34d32026-06-15WarningsExact identifier
unii: K679OBS311
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATECardinal Health 107, LLCb3d5225c-0ee4-481e-b9ec-bc5e1321096d2026-06-12Adverse reactionsExact identifier
unii: XF417D3PSL
REFRESH CELLUVISCCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.b32ed9e8-d091-4f16-b416-5a62cdfee49a2026-06-05WarningsExact identifier
unii: K679OBS311

Reported adverse events (FAERS/openFDA)#

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