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 5 of 7 · 134 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlbuterolALBUTEROLZydus Lifesciences Limiteda4709eea-e4a2-46e2-850f-1e6afca018932024-11-25Exact identifier
rxcui: 197316
rxcui: 197318
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEIngenus Pharmaceuticals, LLCe14f5fd6-d01a-489d-9baa-61778b1352a82024-10-22Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
albuterol sulfateALBUTEROL SULFATEPadagis Israel Pharmaceuticals Ltd489201d2-9ed0-419b-81dc-a7f7f86b59ed2024-09-30Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUREnergique, Inc.87c92497-8a51-4977-87fe-e0b4c6bafb192024-09-27WarningsExact identifier
unii: 368GB5141J
ALBUTEROL SULFATEALBUTEROL SULFATEBryant Ranch Prepack45e07bdd-78f9-4055-9de3-646e67de7eaf2024-08-15Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
ALBUTEROL SULFATEALBUTEROL SULFATELuoxin Aurovitas Pharma (Chengdu) Co., Ltd.1d6be2b8-c670-b783-e063-6294a90ae5032024-07-31Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
ALBUTEROL SULFATEALBUTEROL SULFATEAurobindo Pharma Limited78e6bee2-7113-46cf-8c97-dc61b0f7b94f2024-07-31Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEAmerican Health Packagingb0f73459-baeb-42a7-be48-2c3647d9b2052024-07-30Warnings, Adverse reactionsExact identifier
rxcui: 197316
rxcui: 197318
unii: 021SEF3731
Albuterol sulfateALBUTEROL SULFATENuCare Pharmaceuticals,Inc.b478d9e9-9704-6af2-e053-2995a90aafd42024-07-17Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
VENTOLIN HFAALBUTEROL SULFATENuCare Pharmaceuticals,Inc.7043bc12-8a58-8ff8-e053-2a91aa0ab6272024-07-16Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
VENTOLIN HFAALBUTEROL SULFATENuCare Pharmaceuticals,Inc.54d90668-5237-4330-e054-00144ff88e882024-07-15Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol Sulfate HFAALBUTEROL SULFATENuCare Pharmaceuticals,Inc.8c278b6f-d32b-b750-e053-2995a90ad7e92024-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATEIPRATROPIUM BROMIDE AND ALBUTEROL SULFATEA-S Medication Solutionse452afc2-dc33-4be7-949e-143b2e5f530c2024-06-10Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATEIPRATROPIUM BROMIDE AND ALBUTEROL SULFATEAmerican Health Packagingc04c6ec8-1401-424d-8126-63080e36c4b92024-06-03Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
VENTOLIN HFAALBUTEROL SULFATEA-S Medication Solutionsaa6d5c00-46a5-4f93-95e4-09319abfe71e2024-05-07Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEA-S Medication Solutions19867b61-77a2-46f1-97c7-7fadfec5882b2024-05-07Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
VENTOLIN HFAALBUTEROL SULFATEA-S Medication Solutionsaff836e4-34f2-4ab9-bbf8-0c41ac848cb02024-05-07Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
EnviroclenzBERBERIS VULGARIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, STILLINGIA SYLVATICA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, GERMANIUM SESQUIOXIDE, PHYTOLACCA DECANDRA, ACETONE, AMMONIUM MURIATICUM, BENZINUM, PROPYLENE GLYCOL, SODIUM LAURYL SULFATE, SODIUM TRIPOLYPHOSPHATE, TEREBINTHINA, METHANOL, CHLORINUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUMDeseret Biologicals, Inc.92816bbe-96d6-45fc-9929-d3e6df394a332024-05-02WarningsExact identifier
unii: 368GB5141J
Albuterol Sulfate HFAALBUTEROL SULFATEPrasco Laboratoriesb25d9d6b-eb4c-452e-89ef-10e611deebd62024-04-30Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
VENTOLIN HFAALBUTEROL SULFATEGlaxoSmithKline LLCd92c5d6b-ff10-4087-36a2-1cfc464cb9672024-04-26Warnings, Adverse reactionsExact identifier
unii: 021SEF3731

Reported adverse events (FAERS/openFDA)#

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