FDA.reportPublic FDA data

NDC 69238-1344-01 - 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
69238-1344
Requested NDC
69238-1344-01
Package NDCs from labels
69238-1344-1, 69238-1344-5, 69238-1344-01
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
69238-1344-1Albuterol100 in 1 BOTTLETABLET1007
69238-1344-5Albuterol500 in 1 BOTTLETABLET5007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1344ALBUTEROL 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
69238-1344-1EA - Each69238-134429bb6679-5fac-4f19-876b-f576ef9db7de12018-08-13

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 3 of 7 · 134 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
Albuterol SulfateALBUTEROL SULFATEPreferred Pharmaceuticals Inc.5de6a189-a8b7-4b33-b162-add6b6e4b2752026-01-16Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEPreferred Pharmaceuticals Inc.d6acb5a7-555a-463a-ae65-2911d6789b422026-01-14Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
AlbuterolALBUTEROL SULFATECipla USA Inc.fd0389e0-3713-42e0-8ef2-3bb97676fded2026-01-04Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
ALBUTEROL SULFATEALBUTEROL SULFATEChartwell Governmental & Specialty RX, LLC.dd47559a-84f6-42a5-a00e-48754505418e2025-12-17Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATESandoz Incf8a2c4b7-a162-48ab-90b0-350e4da25c662025-12-16Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATEIPRATROPIUM BROMIDE AND ALBUTEROL SULFATERitedose Pharmaceuticals, LLCe0dee492-8bf9-4360-be9b-9d6ee1ecb2562025-12-10Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Ipratropium Bromide and Albuterol SulfateIPRATROPIUM BROMIDE AND ALBUTEROL SULFATEChartwell RX, LLCb444478a-10ce-484f-9039-6383dfb8161e2025-12-02Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Combivent RespimatIPRATROPIUM BROMIDE AND ALBUTEROLBoehringer Ingelheim Pharmaceuticals, Inc.9832312e-0310-4ab6-8501-afa976fc7eb22025-12-01Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
ALBUTEROL SULFATEALBUTEROL SULFATEBryant Ranch Prepack378461f2-7271-44a3-9da3-b39970b65d3a2025-11-10Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATENephron Pharmaceuticals Corporation574824f3-51cc-4b94-9c10-e3204d8b19f82025-11-07Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEASCLEMED USA INC.8ea40065-4f59-434f-9ea1-7ef006fde66e2025-11-07Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEAsclemed USA, Inc.056e145b-87aa-4009-a7ab-2ac0bd086eb02025-11-06Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATENuCare Pharmaceuticals, Inc.2c3f975c-dbd8-0362-e063-6394a90a16dd2025-10-21Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATENuCare Pharmaceuticals,Inc.4120061a-dbae-8918-e063-6394a90afbf22025-10-14Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEPreferred Pharmaceuticals, Inc.081b7bbb-6692-4512-b135-863b73bf30a52025-10-13Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
AIRSUPRAALBUTEROL SULFATE AND BUDESONIDEAstraZeneca Pharmaceuticals LPe60aa9f9-5139-44df-b886-ebddc3c7eb132025-09-18Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
TRIMO SANOXYQUINOLINE SULFATE AND SODIUM LAURYL SULFATECooperSurgical, Inc.1e4a1caa-e6ba-44ef-8347-07e6385a7c9e2025-09-03WarningsExact identifier
unii: 368GB5141J
Albuterol Sulate HFAALBUTEROL SULFATENuCare Pharmaceuticals,Inc.825975b1-a4a9-78ca-e053-2a91aa0a39482025-09-02Warnings, Adverse reactionsExact identifier
unii: 021SEF3731

Reported adverse events (FAERS/openFDA)#

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