FDA.reportPublic FDA data

NDC 69097-840-34 - 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
69097-840
Requested NDC
69097-840-34
Package NDCs from labels
69097-840-34, 69097-840-53, 69097-840-87, 69097-840-64
Manufacturer
Cipla USA Inc. | The Ritedose Corporation
Effective date
2024-01-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
IPRATROPIUM BROMIDE - Cipla USA Inc. | The Ritedose CorporationCipla USA Inc. | The Ritedose Corporation2024-01-11HUMAN PRESCRIPTION DRUG LABEL
Ipratropium Bromide and Albuterol Sulfate - REMEDYREPACK INC.REMEDYREPACK INC.2023-10-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69097-840-34Ipratropium Bromide and Albuterol Sulfate1 in 1 POUCHSOLUTION14
69097-840-34Ipratropium Bromide and Albuterol Sulfate3 mL in 1 VIALSOLUTION34
69097-840-53Ipratropium Bromide and Albuterol Sulfate30 in 1 CARTONSOLUTION304
69097-840-64Ipratropium Bromide and Albuterol Sulfate2 in 1 CARTONSOLUTION24
69097-840-64Ipratropium Bromide and Albuterol Sulfate30 in 1 POUCHSOLUTION304
69097-840-87Ipratropium Bromide and Albuterol Sulfate30 in 1 POUCHSOLUTION304
69097-840-87Ipratropium Bromide and Albuterol Sulfate1 in 1 CARTONSOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-840IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [CIPLA USA INC.]4Current NDC, Legacy NDC, 7 package rows20240112_89d59bd9-c826-413c-8ed9-a1521a0c7cc5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-840-34ML - Milliliter69097-8405a16cc51-9187-46af-8bb8-bc443a86e1f712020-07-13
69097-840-53ML - Milliliter69097-840b8d75775-7ce3-4c7b-b757-618388fd80a312020-07-13
69097-840-64ML - Milliliter69097-84055e72ceb-891c-4247-a259-e46aa955c45a12021-05-05
69097-840-87ML - Milliliter69097-840b274ad8b-5235-4d08-8633-24b17f4884ac12022-04-06

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 3 of 61 · 1,201 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BioplasmaSILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDEHyland's Inc.dd0a7ed2-d112-4b96-e053-2995a90ac6b62026-07-30WarningsExact identifier
unii: 451W47IQ8X
Hypertonic SalineSODIUM CHLORIDENAVEH PHARMA (1996) LTD167c7a9c-1228-4fb2-a89c-d3e1483863232026-07-30WarningsExact identifier
unii: 451W47IQ8X
Hypertonic Saline Solution Sodium ChlorideSODIUM CHLORIDENAVEH PHARMA (1996) LTD750ea4b1-de2b-4299-aaa2-331daf383d0d2026-07-30WarningsExact identifier
unii: 451W47IQ8X
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
DelflexDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.a98facd6-9daa-4d37-8209-63a0599dbfaa2026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.9a1220fb-6853-45ae-838c-10d8596e1af72026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCaf5cdf1a-19f4-11e2-892e-0800200c9a662026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Ipratropium BromideIPRATROPIUM BROMIDECardinal Health 107, LLC6b730dd7-4d93-403a-bfd2-fa0efa298b752026-07-24Warnings, Adverse reactionsExact identifier
unii: J697UZ2A9J
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions19daf830-7270-4661-81b1-ded38f867f282026-07-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Whisidom Saline SolutionSODIUM CHLORIDE 0.9% SALINE SOLUTIONJiangxi Yudexi Pharmaceutical Co., LTD4e4e4169-2a14-3466-e063-6394a90a081b2026-07-20WarningsExact identifier
unii: 451W47IQ8X
SalineNASALBEST CHOICE (VALU MERCHANDISERS COMPANY)71485e82-bf54-4b8b-8dd2-2a07615345202026-07-17WarningsExact identifier
unii: 451W47IQ8X
Ipratropium BromideIPRATROPIUM BROMIDERising Pharma Holdings, Inc.3249aea8-a395-f09f-e063-6294a90a2d8b2026-07-16Warnings, Adverse reactionsExact identifier
unii: J697UZ2A9J
Albuterol SulfateALBUTEROL SULFATERising Pharma Holdings, Inc.3236f82c-14e9-dfd4-e063-6294a90ac43d2026-07-16Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Ipratropium Bromide and Albuterol SulfateIPRATROPIUM BROMIDE AND ALBUTEROL SULFATERising Pharma Holdings, Inc.3246dfab-61d7-27ba-e063-6294a90ac1802026-07-16Warnings, Adverse reactionsExact identifier
rxcui: 1437702
unii: J697UZ2A9J
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATERising Pharma Holdings, Inc.32377c09-da6d-331c-e063-6294a90a7a462026-07-16Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATERising Pharma Holdings, Inc32474c0e-af35-69d1-e063-6394a90a53c62026-07-16Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Sodium ChlorideSODIUM CHLORIDELABORATORIOS GRIFOLS SAeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf2026-07-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
IPRATROPIUM BROMIDEIPRATROPIUM BROMIDESportpharm LLC7e8fdd92-1e55-47e2-aa85-e48cfebbb8d72026-07-14Warnings, Adverse reactionsExact identifier
unii: J697UZ2A9J
WHWSWB 0.9% SALINESODIUM CHLORIDEYiwu Huanshu E-commerce Co., Ltd5082b773-79b2-2501-e063-6394a90a170f2026-07-11WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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