NDC 69097-321-86 - Budesonide Inhalation Suspension

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
69097-321
Requested NDC
69097-321-86
Package NDCs from labels
69097-321-86, 69097-321-87, 69097-321-32, 69097-321-53
Manufacturer
Cipla USA Inc. | CIPLA LIMITED GOA | CIPLA LIMITED INDORE | Cipla (Jiangsu) Pharmaceutical Co., Ltd.
Effective date
2026-06-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Budesonide Inhalation SuspensionCipla USA Inc. | CIPLA LIMITED GOA | CIPLA LIMITED INDORE | Cipla (Jiangsu) Pharmaceutical Co., Ltd.2026-06-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69097-321-32BudesonideInhalation Suspension2 mL in 1 AMPULEINHALANT212
69097-321-32BudesonideInhalation Suspension1 in 1 POUCHINHALANT112
69097-321-53BudesonideInhalation Suspension30 in 1 CARTONINHALANT3012
69097-321-86BudesonideInhalation Suspension2 mL in 1 AMPULEINHALANT212
69097-321-86BudesonideInhalation Suspension5 in 1 POUCHINHALANT512
69097-321-87BudesonideInhalation Suspension6 in 1 CARTONINHALANT612

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-321BUDESONIDE INHALATION SUSPENSION (BUDESONIDE) INHALANT [CIPLA USA INC.]11Current NDC, Legacy NDC, 6 package rows20240822_c52c5382-1400-44b9-95be-a30e1cf706da.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-321-32ML - Milliliter69097-321eb019ceb-9ce2-46b0-9a47-6b113aa8da2012020-09-14
69097-321-53ML - Milliliter69097-3211b6883a7-5982-4fc4-a3cd-a0fd2ce24e0212020-08-06
69097-321-86ML - Milliliter69097-321f30aa7f6-bcf5-4a34-9751-2b2ef1f87e7312018-03-08
69097-321-87ML - Milliliter69097-32189a7705b-8a3c-4692-84a2-a467bc95564912017-12-14

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 38 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium ChlorideSODIUM CHLORIDESpectra Medical Deviecs, LLC7e316d21-d6ad-4976-bd90-268fd7e513612024-01-12Adverse reactionsExact identifier
unii: 451W47IQ8X
A01 CELLULAR RECHARGEACETICUM ACIDUM, ARNICA MONTANA, AVENA SATIVA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CEANOTHUS AMERICANUS, CERATOSTIGMA ILLMOTTIANUM, CHININUM ARSENICOSUM, CITRICUM ACIDUM, ENGLISH ELM, EUROPEAN HORNBEAM, EUROPEAN OLIVE, GENTIANELLA AMARELLA, HYDROFLUORICUM ACIDUM, JUGLANS REGIA, LACTICUM ACIDUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SILICOFLUORICUM, NATRUM SULPHURICUM, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, SARCOLACTICUM ACIDUM, SOLIDAGO VIRGAUREAApex Energetics Inc.b932ebd3-afea-6a95-e053-2995a90a27352024-01-08WarningsExact identifier
unii: 451W47IQ8X
A12 DTX-KIDNEYAPIS MELLIFICA, BERBERIS VULGARIS, BETULA PUBESCENS BARK, BETULA VERRUCOSA LEAF, BOS TAURUS KIDNEY, BOS TAURUS URINARY BLADDER, CITRICUM ACIDUM, CITRUS LIMONUM, FAGUS SYLVESTRIS FLOWER BUD, NATRUM MURIATICUM, PETROSELINUM SATIVUM, QUERCUS ROBUR FLOWER BUD, SINUSITISINUM, SOLIDAGO VIRGAUREAApex Energetics Inc.bf52e26f-aa27-87ca-e053-2995a90a23e72024-01-08WarningsExact identifier
unii: 451W47IQ8X
B07 DPRSN ANTITOXADRENALINUM, AETHUSA CYNAPIUM, AGNUS CASTUS, ALFALFA, ARGENTUM NITRICUM, AURUM METALLICUM, AVENA SATIVA, CERATOSTIGMA WILLMOTTIANUM FLOWER, CHERRY PLUM FLOWER, DAMIANA, EUROPEAN ASPEN FLOWER, EUROPEAN HORNBEAM FLOWER, GORSE FLOWER, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, MANDRAGORA OFFICINARUM, NATRUM MURIATICUM, PASSIFLORA INCARNATA, ROSA CANINA FLOWER, SEPIA, SWEET CHESTNUT FLOWER, THYROIDINUM, WILD MUSTARD FLOWERApex Energetics Inc.bd1fbb76-4f6f-7098-e053-2a95a90ae25c2024-01-08WarningsExact identifier
unii: 451W47IQ8X
B13 CELL SALT COMPLEXALLIUM SATIVUM, AVENA SATIVA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CARBO VEGETABILIS, FERRUM IODATUM, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, LACTICUM ACIDUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, PHOSPHORICUM ACIDUM, URTICA URENSApex Energetics Inc.bf78b0b0-5b7b-28cb-e053-2a95a90a1e7d2024-01-08WarningsExact identifier
unii: 451W47IQ8X
F01 ANGR-RLSBIG SAGEBRUSH, BOS TAURUS LIVER, GALLBLADDER, BRIZA MAXIMA, CALENDULA OFFICINALIS, CHAMOMILE FLOWER, CHICORY FLOWER, GARLIC, ENGLISH HOLLY FLOWER, EUROPEAN BEECH FLOWER, FORKING LARKSPUR FLOWER, GERMAN CHAMOMILE FLOWER, IMPATIENS GLANDULIFERA FLOWER, LILIUM TIGRINUM, MOUNTAIN DOGWOOD, NATRUM MURIATICUM, NUX VOMICA, RUBBER RABBITBRUSH, VITIS VINIFERA FLOWER, WATERMELON, WHITE WILLOW FLOWER, YELLOW STAR THISTLEApex Energetics Inc.bd0b2eab-b6eb-19ce-e053-2a95a90aebe62024-01-08WarningsExact identifier
unii: 451W47IQ8X
D05 KDNY-DRNAPIS MELLIFERA, ASPARAGUS, BERBERIS VULGARIS ROOT BARK, LYTTA VESICATORIA, CHELIDONIUM MAJUS, JUNIPER BERRY, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, POPULUS TREMULOIDES BARK, RHUS AROMATICA ROOT BARK, RUBIA TINCTORUM ROOT, SAW PALMETTO, SOLIDAGO VIRGAUREA FLOWERING TOP, TARAXACUM OFFICINALE, AND ARCTOSTAPHYLOS UVA-URSI LEAFApex Energetics Inc.146800dc-bb1a-4d4c-803a-156a9fba600d2024-01-08WarningsExact identifier
unii: 451W47IQ8X
F02 ANGR-FLXADELHEID AQUA, ARSENICUM ALBUM, BIG SAGEBRUSH, BOS TAURUS LIVER, GALLBLADDER, BRIZA MAXIMA, CALENDULA OFFICINALIS, CAYENNE, CHAMOMILE , CHICORY , GARLIC, ENGLISH HOLLY , EUROPEAN BEECH , FORKING LARKSPUR , GERMAN CHAMOMILE , IMPATIENS GLANDULIFERA , JUGLANS REGIA , LILIUM TIGRINUM, MORNING GLORY, MOUNTAIN DOGWOOD, NATRUM MURIATICUM, NUX VOMICA, PINUS SYLVESTRIS , REDWOOD, RUBBER RABBITBRUSH, SEPIA, TOLMIE STAR TULIP, VERBENA OFFICINALIS , VITIS VINIFERA , WATERMELON, WHITE WILLOW , YELLOW STAR THISTLEApex Energetics Inc.bc7c2bf3-8b0d-766f-e053-2a95a90ad34c2024-01-08WarningsExact identifier
unii: 451W47IQ8X
F19 STRNG-MNDANACARDIUM ORIENTALE, ARNICA MONTANA, AURUM METALLICUM, CASTANEA SATIVA, CITRUS SINENSIS, CRATAEGUS MONOGYNA, CYTISUS SCOPARIUS, DANDELION, FAGUS SYLVATICA, FUCHSIA, GORSE, HYDRASTIS CANADENSIS, IGNATIA AMARA, IRON, KALI PHOSPHORICUM, MALUS SYLVESTRIS, NATRUM MURIATICUM, PAEONIA CALIFORNICA, POMEGRANATE, PRUNELLA VULGARIS, ROSA CALIFORNICA, SINAPIS ARVENSIS, YARROW, YERBA SANTAApex Energetics Inc.bec4e5d7-d968-175b-e053-2a95a90a4e0a2024-01-08WarningsExact identifier
unii: 451W47IQ8X
F22 SOMATICAAGRIMONY, CALOCHORTUS TOLMIEI, CIMICIFUGA RACEMOSA, CLEMATIS VITALBA, DANDELION, DIPLACUS AURANTIACUS, ECHINACEA ANGUSTIFOLIA, EHRENDORFERIA CHRYSANTHA, FUCHSIA, HYDRASTIS CANADENSIS, KALI PHOSPHORICUM, LARIX DECIDUA, LATHYRUS ODORATUS, LONICERA CAPRIFOLIUM, NATRUM MURIATICUM, ROSA CALIFORNICA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR, YARROW, YERBA SANTAApex Energetics Inc.bed99bed-3902-5278-e053-2a95a90aeab62024-01-08WarningsExact identifier
unii: 451W47IQ8X
F27 MVONAGRIMONY, ARNICA MONTANA, ARSENICUM ALBUM, ARTEMISIA TRIDENTATA, ASPEN, CHAMOMILE, CHICORY, DICENTRA FORMOSA, EHRENDORFERIA CHRYSANTHA, EUCALYPTUS GLOBULUS, HARDY FUCHSIA, HORSE CHESTNUT, IGNATIA AMARA, JUGLANS REGIA, LACHESIS MUTUS, LARIX DECIDUA, MIMULUS GUTTATUS, MOUNTAIN DOGWOOD, NATRUM MURIATICUM, PALLADIUM, PERFOLIATE HONEYSUCKLE, PETUNIA AXILLARIS, PULSATILLA VULGARIS, PYRENEES STAR OF BETHLEHEM, SCOTCH BROOM, TRILLIUM CHLOROPETALUM, YELLOW JASMINE, YERBA SANTA, ZINNIA ELEGANSApex Energetics Inc.bca69508-0934-ecfc-e053-2995a90a0ce32024-01-08WarningsExact identifier
unii: 451W47IQ8X
F26 PRSVRALLIUM CEPA WHOLE, APIS MELLIFICA, AURUM METALLICUM, BORAGE, BROMUS RAMOSUS, CALIFORNIA WILDROSE WHOLE, ENGLISH ELM ING TWIG, ENGLISH HAWTHRON, ENGLISH OAK, EUROPEAN HORNBEAM, EUROPEAN OLIVE, GENTIANELLA AMARELLA, GORSE, LARIX DECIDUA, LUFFA OPERCULATA, MERCURIUS SOLUBILIS, MULLEIN, NATRUM MURIATICUM, PENSTEMON DAVIDSONII WHOLE, PLATINUM METALLICUM, PULSATILLA VULGARIS, PURPLE LOOSESTRIFE WHOLE, ROSA CHINENSIS, SCOTCH BROOM, SEPIA, WILD MUSTARD, YERBA SANTA, ZINCUM METALLICUMApex Energetics Inc.beaef254-bf57-df92-e053-2995a90abd652024-01-08WarningsExact identifier
unii: 451W47IQ8X
G05 OXI-METADENOSINE TRIPHOSPHATE, IGNATIA AMARA, KALI PHOSPHORICUM, NATRUM MURIATICUM, NUX VOMICA, SULPHURApex Energetics Inc.beb18213-911a-38d4-e053-2a95a90ac17c2024-01-08WarningsExact identifier
unii: 451W47IQ8X
LIVER PLUS FormulaADENOSINE TRIPHOSPHATE, IGNATIA AMARA, KALI PHOSPHORICUM, NATRUM MURIATICUM, NUX VOMICA, SULPHURApex Energetics Inc.d8c7b349-8718-d8ed-e053-2995a90ae9882024-01-08WarningsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLC037ac04d-f8f3-4bb8-993a-ac8f7683ff832024-01-04Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sinus HPARSENICUM ALBUM, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA, THUJA OCCIDENTALISEnergique, Inc.3cdddbe5-e3d2-4629-a045-868e18183f1d2023-12-19WarningsExact identifier
unii: 451W47IQ8X
BSSBALANCED SALT SOLUTIONAlcon Laboratories, Inc.28488c7b-cf6a-4a03-916f-cc66b3afdc572023-12-14Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: 1Q73Q2JULR
Altachlore Sodium Chloride HypertonicitySODIUM CHLORIDEAltaire Pharmaceuticals Inc.dc0d94d8-4475-4956-8ded-bdb9496074e42023-12-09WarningsExact identifier
unii: 451W47IQ8X
OracitCITRIC ACID AND SODIUM CITRATECMP Pharma, Inc.bc26abed-8e6e-475d-8ab3-abf7d03770032023-12-07Adverse reactionsExact identifier
unii: 2968PHW8QP
BUDESONIDEBUDESONIDEAurobindo Pharma Limitedc70c734f-2431-4414-bb94-4adda4985e5d2023-12-02Warnings, Adverse reactionsExact identifier
rxcui: 351109
unii: Q3OKS62Q6X

Reported adverse events (FAERS/openFDA)#

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