FDA.reportPublic FDA data

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 19 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Homeopathic Calm DropsARSENIC TRIOXIDE 30C, MATRICARIA CHAMOMILLA12X, ARABICA COFFEE BEAN 30X, POTASSIUM CARBONATE30C, STRYCHNOS IGNATII SEED30X, LACHESIS MUTA VENOM12X, PHOSPHORIC ACID 3X, ANEMONE PULSATILLA 12C, VALERIAN 30C, ACONITUM NAPELLUS 6X, CHLORIDE ION 12X, STRYCHNOS NUX-VOMICA SEED 30CHISTORICAL REMEDIES LLP.69c35bc2-b9a0-4bb4-a56d-0e2d1c3f79582025-10-07WarningsExact identifier
unii: 451W47IQ8X
Homeopathic Moon dropsARSENIC CATION 30X, MATRICARIA CHAMOMILLA 6X, ARABICA COFFEE BEAN 12X, GELSEMIUM SEMPERVIRENS ROOT 12X, STRYCHNOS IGNATII SEED 30X, LYCOPODIUM CLAVATUM SPORE 30X, SODIUM CHLORIDE 30X, STRYCHNOS NUX VOMICA SEED 30X, VALERIAN 12C,Historical Remedies LLP0e7972a5-a930-4a52-8896-02ce810fa90b2025-10-07WarningsExact identifier
unii: 451W47IQ8X
Tri-Relief AntifungalSODIUM CHLORIDE, SILICON DIOXIDE, AND THUJA OCCIDENTALIS LEAFY TWIGForces of Nature6fe97b54-8aa3-4d86-9055-0629589a416b2025-10-06WarningsExact identifier
unii: 451W47IQ8X
VirexADENOVIREN NOSODE, ASCLEPIAS TUBEROSA, CALCAREA ARSENICICA, CAMPHORA, COXSACKIE A2 NOSODE, COXSACKIE A3 NOSODE, COXSACKIE A4 NOSODE, COXSACKIE A5 NOSODE, COXSACKIE A7 NOSODE, COXSACKIE B1 NOSODE, COXSACKIE B3 NOSODE, COXSACKIE B4 NOSODE, COXSACKIE B5 NOSODE, CYTOMEGALOVIRUS NOSODE, ECHINACEA PURPUREA, EPSTEIN-BARR VIRUS NOSODE, EUPHRASIA OFFICINALIS, INFLUENZINUM, LAC VACCINUM, MORBILLINUM, NATRUM MURIATICUM, PHYTOLACCA DECANDRA, THUJA OCCIDENTALIS, TRIFOLIUM PRATENSE, VARIOLINUMNutritional Specialties, Inc.4baa5c95-79a6-4ae8-a8c4-1edbf308f92c2025-10-03WarningsExact identifier
unii: 451W47IQ8X
BudesonideBUDESONIDEApotex Corp.f1aac35a-bc72-dd68-8179-8661354589cb2025-09-22WarningsExact identifier
unii: Q3OKS62Q6X
Jet LagECHINACEA, ALUMINA, ARALIA QUINQUEFOLIA, ARGENTUM, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IODIUM, KALI CARBONICUM, KALI IODATUM, LYCOPODIUM CLAVATUM, LYCOPUS VIRGINICUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOXICODENDRON, SABAL SERRULATA, THYROIDINUM.Newton Laboratories, Inc.9c21c935-4ebc-1efd-e053-2995a90aa1562025-09-18WarningsExact identifier
unii: 451W47IQ8X
AIRSUPRAALBUTEROL SULFATE AND BUDESONIDEAstraZeneca Pharmaceuticals LPe60aa9f9-5139-44df-b886-ebddc3c7eb132025-09-18Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
GAVILYTE-NPOLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATELupin Pharmaceuticals,Inc.27195187-75a3-431f-90d9-84da1b94e8492025-09-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
GaviLyte - C TMPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACKLupin Pharmaceuticals,Inc.a8b15625-ca7c-4d57-9f36-3ac2a6d136652025-09-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
GAVILYTE G TMPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTESLupin Pharmaceuticals,Inc.3978822b-6473-4072-9f80-20ceb9bea3552025-09-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Schuessler Tissue Salts Comb 12 General TonicCALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEAMartin & Pleasance Pty Ltd9083a01b-2fbe-4e04-9eec-bf4f65950ec72025-09-09WarningsExact identifier
unii: 451W47IQ8X
Schuessler Tissue Salts Comb 12 General TonicCALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM ,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEAMartin & Pleasance Pty Ltdc14c79ab-85bb-45f2-83d1-1d9c298ffdfd2025-09-08WarningsExact identifier
unii: 451W47IQ8X
Polyethylene Glycol 3350 and electrolytes - UnflavoredPOLYETHYLENE GLYCOL 3350 AND ELECTROLYTES - UNFLAVOREDStrides Pharma Science Limited48c741a9-9039-4fdb-a875-86d4ea9682822025-09-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
PULMICORT FLEXHALERBUDESONIDERubicon Holdings Inc.ae1105cd-69fc-4c15-937f-c535304341c22025-09-04Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride - UnflavoredPOLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE - UNFLAVOREDStrides Pharma Science Limited37c111ec-5b62-42b9-bbb2-3b0c530e34c92025-09-01Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Dextrose and Sodium ChlorideDEXTROSE AND SODIUM CHLORIDEBaxter Healthcare Companydcbf1907-1841-4afc-ab5d-a9893a2d72562025-08-26Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
terrasil Fast and Natural Wart RemovalGRAPHITE 10X, NATRUM MURIATICUM 3X, SYMPHYTUM OFFICINALE (COMFREY) 1X, THUJA OCCIDENTALIS 3XAidance Scientific, Inc.3d367c0f-5a28-eded-e063-6394a90ad2dc2025-08-25WarningsExact identifier
unii: 451W47IQ8X
Cold Sore Treatment Extra StrengthECHINACEA ANGUSTIFOLIA WHOLE, SODIUM CHLORIDE, THUJA OCCIDENTALIS LEAFY TWIG, AND CALENDULA OFFICINALIS FLOWERING TOPForces of Nature0a5d32dc-c0e7-404e-85f2-6c3a338560ba2025-08-22WarningsExact 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.994cbc8e-a221-1548-e053-2995a90a1f7f2025-08-20WarningsExact identifier
unii: 451W47IQ8X
Medique Medi SeltzerASPIRIN, CITRIC ACID, SODIUM BICARBONATEUnifirst First Aid Corporation528da9d9-2a52-4c16-b7b2-61b3eee1abea2025-08-19WarningsExact identifier
unii: 2968PHW8QP

Reported adverse events (FAERS/openFDA)#

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