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 8 of 61 · 1,202 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GoLYTELYPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEAzurity Pharmaceuticals, Inc.7609ecf7-0ce0-4fbb-9c27-30987f6895752026-04-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
TRILYTEPOLYETHYLENE GLYOCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDEAurobindo Pharma Limited79f5e596-8d51-4227-afcc-f5e3411509572026-04-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Anxiety ReliefACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, AURUM METALLICUM, GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, IGNATIA AMARA, KALI CARBONICUM, MOSCHUS, NATRUM MURIATICUM, PIPER METHYSTICUMNaturalCare9f982e89-655c-49be-85d8-4099a02ed0212026-04-15WarningsExact identifier
unii: 451W47IQ8X
PEG 3350, sodium chloride, sodium bicarbonate and potassium chloridePOLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDEWilshire Pharmaceuticals, Inc.4e442a72-b13b-4869-8a1d-59356095b0912026-04-14Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
AlbuterolALBUTEROLAmneal Pharmaceuticals NY LLC230d66fc-f62c-42a6-adb3-0a0f879c8ad42026-04-14Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
SODIUM CHLORIDE 1 GRAMSODIUM CHLORIDEGendose Pharmaceuticals, LLCce988ae5-61c6-4324-90e1-a94c8a54d0d02026-04-13WarningsExact identifier
unii: 451W47IQ8X
Albuterol sulfateALBUTEROL SULFATEREMEDYREPACK INC.0cfb6c5d-eac2-4a1c-8a0f-6b00e819adda2026-04-13Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Quantum ResonanceALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUMDeseret Biologicals, Inc.f94a10bd-1c40-42c7-b458-b580706145492026-04-10WarningsExact identifier
unii: 451W47IQ8X
Quantum ResonanceALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUMDeseret Biologicals, Inc.1467111a-bef6-473d-b7f2-3309a9bb72ce2026-04-10WarningsExact identifier
unii: 451W47IQ8X
Ipratropium Bromide and Albuterol SulfateIPRATROPIUM BROMIDE AND ALBUTEROL SULFATESun Pharmaceutical Industries, Inc.38f9a201-3954-4370-8e71-7ec2df88a1ff2026-04-09Warnings, Adverse reactionsExact identifier
rxcui: 1437702
unii: J697UZ2A9J
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATESun Pharmaceutical Industries, Inc.bb538b7d-e390-419a-9404-a57c1db4a4472026-04-09Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATECardinal Health 107, LLC6ec88f64-66a2-4ca9-9913-c192fc33f88b2026-04-08Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
H-Focus FormulaAGNUS CASTUS, AVENA SATIVA, BARYTA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, SILICEA, ZINCUM METALLICUMHealing Natural Oils LLC4ee42911-3064-7f55-e063-6294a90abcc72026-04-07WarningsExact identifier
unii: 451W47IQ8X
H-Mood FormulaAGRIMONIA EUPATORIA, FLOS, ANACARDIUM ORIENTALE, AURUM METALLICUM, AVENA SATIVA, BORAGO OFFICINALIS, CAPSICUM ANNUUM, CARPINUS BETULUS, FLOS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, HYPERICUM PERFORATUM, KALI BROMATUM, LARIX DECIDUA, FLOS, NATRUM CARBONICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PULSATILLA, SILICEA, SINAPSIS ARVENSIS, FLOS, TABACUMHealing Natural Oils LLC4ee5c82e-9edf-c36e-e063-6394a90a237f2026-04-07WarningsExact identifier
unii: 451W47IQ8X
Walgreens Sodium Chloride Ophthalmic 5 Percent Hypertonicity EyeSODIUM CHLORIDEWalgreen Companybda3b9db-5fc4-408c-a5ae-d1eeb3ee308d2026-04-06WarningsExact identifier
unii: 451W47IQ8X
Albuterol SulfateALBUTEROL SULFATENephron Pharmaceuticals Corporation285a656c-f77f-4e77-b0a8-a0e9c901803f2026-04-06Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Sodium Chloride Ophthalmic 5 Percent Hypertonicity EyeSODIUM CHLORIDEHanlim4ee80e16-1bb1-8238-e063-6294a90aa7192026-04-04WarningsExact identifier
unii: 451W47IQ8X
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC SODIUM CHLORIDESODIUM CHLORIDEHospira, Inc.376093e7-e09e-4a57-3199-195e452518662026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Migraine and HeadacheIRIS VERSICOLOR ROOT AND SODIUM CHLORIDEForces of Nature0dd2f2e2-78e2-435e-b7b2-ca590953ff942026-04-01WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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