FDA.reportPublic FDA data

NDC 65862-906-01 - Ipratropium Bromide and Albuterol Sulfate

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
65862-906
Requested NDC
65862-906-01
Package NDCs from labels
65862-906-05, 65862-906-30, 65862-906-60, 65862-906-01, 65862-906-03
Manufacturer
Aurobindo Pharma Limited | Eugia Pharma Specialities Limited
Effective date
2023-10-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ALBUTEROL SULFATE - Aurobindo Pharma Limited | Eugia Pharma Specialities LimitedAurobindo Pharma Limited | Eugia Pharma Specialities Limited2023-10-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-906-01Ipratropium Bromide and Albuterol Sulfate1 in 1 POUCHSOLUTION14
65862-906-01Ipratropium Bromide and Albuterol Sulfate3 mL in 1 VIAL, SINGLE-DOSESOLUTION34
65862-906-03Ipratropium Bromide and Albuterol Sulfate30 in 1 CARTONSOLUTION304
65862-906-05Ipratropium Bromide and Albuterol Sulfate5 in 1 POUCHSOLUTION54
65862-906-05Ipratropium Bromide and Albuterol Sulfate3 mL in 1 VIAL, SINGLE-DOSESOLUTION34
65862-906-30Ipratropium Bromide and Albuterol Sulfate6 in 1 CARTONSOLUTION64
65862-906-60Ipratropium Bromide and Albuterol Sulfate5 in 1 POUCHSOLUTION54
65862-906-60Ipratropium Bromide and Albuterol Sulfate12 in 1 CARTONSOLUTION124

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-906IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [AUROBINDO PHARMA LIMITED]4Current NDC, Legacy NDC, 8 package rows20231101_370516c4-718f-4a71-bdc8-8822060ccefe.zip

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 17 of 61 · 1,202 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ReHydrationADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KALI PHOS, NAT MUR, SARSAPARILLA, SILICEA, TARAXACUM, THYROIDINUMEnergetix Corporation9b532a31-530a-44f9-843f-f395a3e460b82025-12-17WarningsExact identifier
unii: 451W47IQ8X
ALBUTEROL SULFATEALBUTEROL SULFATEChartwell Governmental & Specialty RX, LLC.dd47559a-84f6-42a5-a00e-48754505418e2025-12-17Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Equate Yeast ReliefCANDIDA ALBICANS, WOOD CREOSOTE, SODIUM CHLORIDE, AND SULFURWAL-MART STORES INCd96aa608-ed8a-36cd-e053-2a95a90ac2862025-12-17WarningsExact identifier
unii: 451W47IQ8X
OP-PEMOTIONAL HEALTH BOOSTERVitality Works, Inc.a8b87a49-fc73-4494-8dc9-059bc5f82d422025-12-17WarningsExact identifier
unii: 451W47IQ8X
Vital-FLBODY FLUID BALANCEVitaltiy Works, Inc.13207197-7ef7-49a3-8970-5f98299a75d22025-12-17WarningsExact identifier
unii: 451W47IQ8X
Woman PowerAGNUS, ARALIA QUIN, ARNICA, DAMIANA, LACTUCA, NAT MUR, ONOSMODIUM VIRGINIANUM, OOPHORINUM, PHOSPHORICUM AC, PITUITARUM POSTERIUM, SALIX NIG, SEPIA, THUJA OCCEight and Company L.L.C614d47de-742b-4944-89c8-59f2f58dc8b92025-12-17WarningsExact identifier
unii: 451W47IQ8X
PSORIASIS HPARSENICUM ALBUM, ARSENICUM IODATUM, BORAX, CALCAREA CARBONICA, GRAPHITES, MEZEREUM, PROTEUS, NATRUM MURIATICUM, PHYTOLACCA DECANDRA, SEPIA, SILICEA, SULPHUR, THYROIDINUMNatural Creations, Inc.d2522637-fd16-4246-90d8-f90fb224550e2025-12-16WarningsExact identifier
unii: 451W47IQ8X
MoodARALIA QUIN, CIMICIFUGA, SPIGELIA ANTH, ARG NIT, ARSENICUM ALB, AURUM MET, IGNATIA AMARA, LACHESIS, LYCOPODIUM, NAT MUR, PHOSPHORICUM AC, PLATINUM MET, PULSATILLA, SEPIA, THUJA OCCNatural Creations, Inc7f143f30-2b72-4e6c-985c-8d3a485dbdb42025-12-16WarningsExact identifier
unii: 451W47IQ8X
Albuterol SulfateALBUTEROL SULFATESandoz Incf8a2c4b7-a162-48ab-90b0-350e4da25c662025-12-16Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
IODIUM HPBARIUM CARBONATE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, FUCUS VESICULOSUS, IODINE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTED, THYROIDNatural Creations, Inc.9353d604-e168-4df1-9726-e965c9fc2c782025-12-16WarningsExact identifier
unii: 451W47IQ8X
HemorrhoidAESCULUS HIPP, HAMAMELIS, ALOE, CALC PHOS, CARBO AN, CARBO VEG, LACHESIS, LYCOPODIUM, MURIATICUM AC, NITRICUM AC, NUX VOM, PAEONIA, RATANHIA, SEPIA, SULPHURNatural Creations, Incdb1b3aef-ba92-417c-b6f6-58e950ed42142025-12-16WarningsExact identifier
unii: QTT17582CB
SINUS HPAMBROSIA ARTEMISIIFOLIA, ARSENIC TRIOXIDE, CALCIUM SULFIDE, POTASSIUM DICHROMATE, POTASSIUM SULFATE, LYCOPODIUM CLAVATUM SPORE, MERCURIUS SOLUBILIS, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, THUJA OCCIDENTALIS LEAFY TWIGNatural Creations, Inc.f017da22-74c2-40f4-adcc-5e84b6ea52912025-12-16WarningsExact identifier
unii: 451W47IQ8X
Hydrate 1BERBERISAQUI,BETAVULGARIS,BOLDO,CARDUUSMARIANUS,CHELIDONIUMMAJUS,ELEUTHEROCOCCUS SENTICOSUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,TARAXACUMOFFICINALE,XANTHOXYLUMFRAXINEUM,ULMUSFULVA,GLYCYRRHIZAGLABRA,GETTYSBURGAQUA,WILDBADAQUA,CARLSBADAQUA,ATP,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUA,HYDROGENNatural Creations, Inc189bc53c-5d75-48df-a74e-cfff2d08d3a92025-12-16WarningsExact identifier
unii: 451W47IQ8X
Hydrate 2BERBERISAQUIFOLIUM,BETAVULGARIS,BOLDO,CHELIDONIUMMAJUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,CARDUUSMARIANUS,TARAXACUMOFFICINALE,AVENASATIVA,ELEUTHEROCOCCUSSENTICOSUS,XANTHOXYLUMFRAXINEUM,EQUISETUMHYEMALE,HYPERICUMPERFORATUM,ULMUSFULVA,GETTYSBURGAQUA,GLYCYRRHIZAGLABRA,WILDBADAQUA,CARLSBADAQUA,ATP,HYDROGEN,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUANatural Creations, Inc1122605f-715e-4f12-9d9d-a20442f9cd452025-12-16WarningsExact identifier
unii: 451W47IQ8X
Migraine Headache TherapyATROPA BELLADONNA - BRYONIA ALBA ROOT - BLACK COHOSH - ARABICA COFFEE BEAN - NITROGLYCERIN - IRIS VERSICOLOR ROOT - SODIUM CHLORIDE -TRP Company317d3f42-783e-02b7-e054-00144ff88e882025-12-15WarningsExact identifier
unii: 451W47IQ8X
Mucus and Sinus Mucus and Sinus Symptom ReliefBRYONIA ALBA, HYDRASTIS CANADENSIS, KALI BICHROMICUM, NATRUM MURIATICUM, PULSATILLA PRATENSIS, SILICEA, STANNUM METALLICUM, THUJA OCCIDENTALIS, ZINCUM GLUCONICUMTRP Company2a42c4a3-9486-9b29-e063-6294a90a7c702025-12-15WarningsExact identifier
unii: 451W47IQ8X
Natural Relief Cold and Flu Plus ZincALLIUM CEPA, ARSENICUM ALBUM, BRYONIA ALBA, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, NATRUM MURIATICUM, NUX VOMICA, SILICEA, SULPHUR, ZINCUM GLUCONICUMTRP Company2a352cf2-48fb-4862-e063-6294a90a2eeb2025-12-15WarningsExact identifier
unii: 451W47IQ8X
Natural Relief Cough and Congestion Cough and Congestion Symptom ReliefANTIMONIUM TARTARICUM, COCCUS CACTI, CUPRUM METALLICUM, DROSERA ROTUNDIFOLIA, ECHINACEA ANGUSTIFOLIA, KALI CARBONICUM, MEPHITIS MEPHITICA, NATRUM MURIATICUM, RUMEX CRISPUS, ZINCUM GLUCONICUMTRP Company2a430f41-bd33-32af-e063-6394a90ae8012025-12-15WarningsExact identifier
unii: 451W47IQ8X
Sinu-RiteGLYCYRRHIZA, KALI BIC, NAT MUR, PULSATILLA, SAMBUCUSSILVER STAR BRANDSb79e177c-6bd7-2f9a-e053-2a95a90abedb2025-12-12WarningsExact identifier
unii: 451W47IQ8X
IPRATROPIUM BROMIDEIPRATROPIUM BROMIDEAdvagen Pharma Ltdbb5f7711-595f-4f7c-9e89-66d029ccbccb2025-12-12Warnings, Adverse reactionsExact identifier
unii: J697UZ2A9J

Reported adverse events (FAERS/openFDA)#

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