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 30 of 61 · 1,202 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlbuterolALBUTEROLRising Pharma Holdings, Inc.40f3cdbc-c9ee-4a3c-8061-a44b9a1d035c2025-03-06Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Bestmade Natural Products BM244CALC CARB, CALC PHOS, CARBO VEG, NAT MUR, PHYSOSTIGMA, RUTA GRAV.Bestmade Natural Products2f853410-e831-90ce-e063-6394a90a26b12025-03-04WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM214CARBO VEG, FERRUM PHOS, SILICA, KALI CARB, CALC PHOS, NAT MURBestmade Natural Products2f6e08d8-a6f9-c049-e063-6394a90a6df12025-03-03WarningsExact identifier
unii: 451W47IQ8X
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
Adrenal LiquescenceGLYCYRRHIZA GLABRA, ROSA CANINA, ARALIA QUINQUEFOLIA, GLANDULA SUPRARENALIS (BOVINE), ADRENALINUM, CINCHONA OFFICINALIS, NATRUM MURIATICUM, ZINCUM METALLICUM, ADRENOCORTICOTROPHINNutritional Specialties, Inc.5254181b-188e-4ef2-b91e-15e87e31de702025-02-26WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM188ALLIUM CEPA, AMBROSIA ARTEMISIA, GELSEMIUM, KALI BICHROME, NAT MUR, SABADILLABestmade Natural Products2e950192-e5cf-37b4-e063-6394a90a1e9a2025-02-20WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM168CONIUM, PILOCARPINE MURIATE, KALI SIL, KALI ARS, SULPHUR, NAT MURBestmade Natural Products2e7bc230-8a37-9975-e063-6294a90a15e72025-02-19WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM173ECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBestmade Natural Products2e7de086-a4c1-ae9e-e063-6394a90aa5f52025-02-19WarningsExact identifier
unii: 451W47IQ8X
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R
NATRUM MURIATICUM 200ckNATRUM MURIATICUMSEVENE USAcf892234-de72-37e1-e053-2995a90a1c392025-02-11WarningsExact identifier
unii: 451W47IQ8X
Natrum Muriaticum 6XSODIUM CHLORIDESEVENE USAff0d279e-210a-6f8a-e053-6294a90a11dc2025-02-11WarningsExact identifier
unii: 451W47IQ8X
Stage Fright-FearACONITUM NAP., ANACARDIUM, ARG. NIT., ARSENICUM ALB., CYPRIPEDIUM, GELSEMIUM, IGNATIA, KALI CARB., LYCOPODIUM, NAT.MUR., PHOS., SAMBUCUS NIG., SEPIA, STAPHYSAG., STRAMONIUM, TARENTULA HISPANA, THERIDION, PASSIFLORA, VALERIANANewton Laboratories, Inc.2df84360-dfff-9851-e063-6394a90ad7902025-02-11WarningsExact identifier
unii: 451W47IQ8X
12 CELL SALTS COMPLEXCALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SILICEASEVENE USAff0f69cd-97a2-7183-e053-6394a90ad0392025-02-10WarningsExact identifier
unii: 451W47IQ8X
Stress-TensionCHAMOMILLA, HYPERICUM PERFORATUM, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, ARGENTUM NITRICUM, AURUM METALLICUM, BAPTISIA, BRYONIA, CHELIDONIUM MAJUS, CIMICIFUGA RACEMOSA, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, LILIUM TIGRINUM, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PICRICUM ACIDUM, PLUMBUM METALLICUM, SEPIA, STAPHYSAGRIA, STRAMONIUM, THUJA OCCIDENTALIS, ZINCUM METALLICUM.Newton Laboratories, Inc.9d22bedb-9f9d-8421-e053-2a95a90acf4a2025-02-10WarningsExact identifier
unii: 451W47IQ8X
Stress-TensionCHAMOMILLA, HYPERICUM PERFORATUM, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, ARGENTUM NITRICUM, AURUM METALLICUM, BAPTISIA, BRYONIA, CHELIDONIUM MAJUS, CIMICIFUGA RACEMOSA, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, LILIUM TIGRINUM, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PICRICUM ACIDUM, PLUMBUM METALLICUM, SEPIA, STAPHYSAGRIA, STRAMONIUM, THUJA OCCIDENTALIS, ZINCUM METALLICUM.Newton Laboratories, Inc.9d23e5da-4806-8ccc-e053-2995a90a19012025-02-10WarningsExact identifier
unii: 451W47IQ8X
VitalityECHINACEA, LAPPA MAJOR, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, ADRENALINUM, ALOE, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, BRYONIA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, DIGITALIS PURPUREA, FERRUM METALLICUM, GLONOINUM, HYDROCOTYLE ASIATICA, IODIUM, IRIS VERSICOLOR, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, THUJA OCCIDENTALIS, THYROIDINUM, GLYCYRRHIZA GLABRANewton Laboratories, Inc.9d3a6b0e-a23f-9f2d-e053-2995a90a75cf2025-02-10WarningsExact identifier
unii: 451W47IQ8X
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
IncontinenceALOE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BENZOICUM ACIDUM, BRYONIA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM, IGNATIA, KALI PHOS., LYCOPODIUM, NAT. MUR., NITRICUM AC., PLANTAGO, PULSATILLA, RHUS AROMATICA , SABAL, SECALE, SEPIA, STAPHYSAG.,STRAMONIUM, THYROIDINUM, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.9c0cd92b-905d-f90f-e053-2995a90a47052025-02-07WarningsExact identifier
unii: 451W47IQ8X
IncontinenceALOE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BENZOICUM ACIDUM, BRYONIA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM, IGNATIA, KALI PHOS., LYCOPODIUM, NAT. MUR., NITRICUM AC., PLANTAGO, PULSATILLA, RHUS AROMATICA , SABAL, SECALE, SEPIA, STAPHYSAG.,STRAMONIUM, THYROIDINUM, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.9c0d8c82-6c4f-a511-e053-2995a90a793f2025-02-07WarningsExact identifier
unii: 451W47IQ8X
Albuterol SulfateALBUTEROL SULFATENuCare Pharmaceuticals,Inc.813d49be-3651-6759-e053-2991aa0a6a9f2025-02-06Warnings, Adverse reactionsExact identifier
unii: 021SEF3731

Reported adverse events (FAERS/openFDA)#

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