FDA.reportPublic FDA data

NDC 50090-1382-00 - 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
50090-1382
Requested NDC
50090-1382-00
Package NDCs from labels
50090-1382-0, 50090-1382-00
Manufacturer
A-S Medication Solutions
Effective date
2024-06-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE - A-S Medication SolutionsA-S Medication Solutions2024-06-10HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1382-02023-02-07C16284748780-1f386c649-f8c6-0266-e053-dadaa90a7c1aIpratropium Bromide and Albuterol Sulfate Inhalation Solution 0.5 mg / 3 mg per 3 mL (RDP)
50090-1382-02023-01-30C16284748780-1f386c649-f8c6-0266-e053-dadaa90a7c1aIpratropium Bromide and Albuterol Sulfate Inhalation Solution 0.5 mg / 3 mg per 3 mL (RDP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1382-0IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE3 mL in 1 VIALSOLUTION318
50090-1382-0IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE30 in 1 CARTONSOLUTION3018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1382IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [A-S MEDICATION SOLUTIONS]18Current NDC, Legacy NDC, 2 package rows20240612_e452afc2-dc33-4be7-949e-143b2e5f530c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1382-0ML - Milliliter50090-138299af8832-e85f-4b08-a889-7cb38083d22c12021-09-07

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 1 of 8 · 157 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATEIPRATROPIUM BROMIDE AND ALBUTEROL SULFATERedpharm Drug594bb030-e6e5-1da4-e063-6394a90aba552026-08-18Warnings, Adverse reactionsExact identifier
application number: ANDA202496
rxcui: 1437702
unii: J697UZ2A9J
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEArmstrong Pharmaceuticals, Inc.17858afa-dcdf-4612-b475-3b6baadfb6392026-08-06Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATENuCare Pharmaceuticals, Inc.583c6408-45cc-9121-e063-6294a90afcc42026-08-04Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Ipratropium BromideIPRATROPIUM BROMIDECardinal Health 107, LLC6b730dd7-4d93-403a-bfd2-fa0efa298b752026-07-24Warnings, Adverse reactionsExact identifier
unii: J697UZ2A9J
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
IPRATROPIUM BROMIDEIPRATROPIUM BROMIDESportpharm LLC7e8fdd92-1e55-47e2-aa85-e48cfebbb8d72026-07-14Warnings, Adverse reactionsExact identifier
unii: J697UZ2A9J
Albuterol SulfateALBUTEROL SULFATEHAWAII REPACK, INC.b18fad6e-f117-4840-83b7-8c261c646af12026-07-03Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEAmerican Health Packaging4aec7f59-b429-4b0e-a779-8df1dd8f80d72026-06-23Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Ipratropium Bromide and Albuterol SulfateIPRATROPIUM BROMIDE AND ALBUTEROL SULFATECipla USA Inc.3c64255e-074c-41f8-a344-3686a06850202026-06-22Warnings, Adverse reactionsExact identifier
rxcui: 1437702
unii: J697UZ2A9J
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEREMEDYREPACK INC.0f9bf2c8-55c0-4b4d-97de-d6c7220c38622026-06-17Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Ipratropium BromideIPRATROPIUM BROMIDECardinal Health 107, LLC51350fab-a919-4d97-9d0c-d9dc7286244c2026-06-02Warnings, Adverse reactionsExact identifier
unii: J697UZ2A9J
Ipratropium BromideIPRATROPIUM BROMIDERedpharm Drug52c63e41-dbbc-d9d7-e063-6294a90a30c92026-05-27Warnings, Adverse reactionsExact identifier
unii: J697UZ2A9J
Ipratropium Bromide and Albuterol SulfateIPRATROPIUM BROMIDE AND ALBUTEROL SULFATEA-S Medication Solutions65504330-6c02-4e30-9f32-51393e06f20c2026-05-22Warnings, Adverse reactionsExact identifier
rxcui: 1437702
unii: J697UZ2A9J
unii: 021SEF3731
ALBUTEROL SULFATEALBUTEROL SULFATECipla USA Inc.c4d6d76a-14b8-411a-8019-e2c923c2c5322026-05-20Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEAmerican Health Packagingb0a5da99-6553-4088-ae27-7fa1944383402026-05-20Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Ipratropium Bromide and Albuterol SulfateIPRATROPIUM BROMIDE AND ALBUTEROL SULFATEPreferred Pharmaceuticals Inc.66f32a06-c880-4b5b-837b-951e1e01e0402026-05-13Warnings, Adverse reactionsExact identifier
rxcui: 1437702
unii: J697UZ2A9J
unii: 021SEF3731

Reported adverse events (FAERS/openFDA)#

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