FDA.reportPublic FDA data

NDC 69238-1345-05 - Albuterol

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
69238-1345
Requested NDC
69238-1345-05
Package NDCs from labels
69238-1345-1, 69238-1345-5, 69238-1345-05
Manufacturer
Amneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals Private Limited
Effective date
2026-04-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Albuterol Tablets, USP (2 mg and 4 mg) Rx onlyAmneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals Private Limited2026-04-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1345-1Albuterol100 in 1 BOTTLETABLET1007
69238-1345-5Albuterol500 in 1 BOTTLETABLET5007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1345ALBUTEROL TABLET [AMNEAL PHARMACEUTICALS NY LLC]6Current NDC, Legacy NDC, 2 package rows20241220_230d66fc-f62c-42a6-adb3-0a0f879c8ad4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1345-1EA - Each69238-1345e73f277e-4294-4cb5-8048-55da25e57b2f12018-08-13

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 7 · 136 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
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
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
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
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
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEREMEDYREPACK INC.0f9bf2c8-55c0-4b4d-97de-d6c7220c38622026-06-17Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Ipratropium Bromide and Albuterol SulfateIPRATROPIUM BROMIDE AND ALBUTEROL SULFATEA-S Medication Solutions65504330-6c02-4e30-9f32-51393e06f20c2026-05-22Warnings, Adverse reactionsExact identifier
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
unii: 021SEF3731
Albuterol Sulfate Inhalation Solution, 0.5%ALBUTEROL SULFATERitedose Pharmaceuticals, LLCfdb4ac5a-bf0d-4896-89f7-1828c081b79e2026-04-30Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol Sulfate Inhalation SolutionALBUTEROL SULFATERitedose Pharmaceuticals, LLCd4c532be-1f41-60d3-e053-2995a90a98be2026-04-30Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATERitedose Pharmaceuticals, LLCb72742df-1a6b-4483-aff3-3e79db5e015d2026-04-30Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
albuterol sulfateALBUTEROL SULFATESportpharm LLC440a96bb-9e69-bdcc-e063-6294a90a67932026-04-24Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATESportpharm LLCa33e20e0-3936-450d-a9d9-3ff51c6f26c52026-04-24Warnings, Adverse reactionsExact identifier
unii: 021SEF3731

Reported adverse events (FAERS/openFDA)#

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