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 4 of 7 · 134 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALBUTEROL SULFATEALBUTEROL SULFATEQUAGEN PHARMACEUTICALS LLC99a490cc-e41d-436b-9cf3-8facb7ac714f2025-07-03Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol sulfateALBUTEROL SULFATEPreferred Pharmaceuticals, Inc.99782bc8-56d9-41f8-935e-0d0de27f0c342025-05-19Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEPreferred Pharmaceuticals Inc.1c72fd84-7dbc-45d0-ab88-fb4221ce369f2025-05-16Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol sulfateALBUTEROL SULFATEAsclemed USA, Inc.264e2145-c7d4-4f4f-aa5b-9fe48a7c5b472025-05-07Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
AlbuterolALBUTEROLBryant Ranch Prepack601a18ed-d66e-498f-a804-f1a3330827d42025-04-21Warnings, Adverse reactionsExact identifier
rxcui: 197318
unii: 021SEF3731
Ipratropium Bromide and Albuterol SulfateIPRATROPIUM BROMIDE AND ALBUTEROL SULFATENephron Pharmaceuticals Corporationae35ec1f-526a-49bf-8262-c50e40190d1f2025-04-08Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEProficient Rx LPa6545fbe-b0a6-41ae-8bb6-91af38410f562025-04-01Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
ALBUTEROL SULFATEALBUTEROL SULFATEChartwell RX, LLC560df50c-e2c4-459f-9d89-bf7e6588949e2025-03-28Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATENephron Pharmaceuticals Corporationecc00500-58b8-491f-80df-dc6c89a08cae2025-03-21Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
AlbuterolALBUTEROLRising Pharma Holdings, Inc.40f3cdbc-c9ee-4a3c-8061-a44b9a1d035c2025-03-06Warnings, Adverse reactionsExact identifier
rxcui: 197316
rxcui: 197318
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATENuCare Pharmaceuticals,Inc.813d49be-3651-6759-e053-2991aa0a6a9f2025-02-06Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol sulfateALBUTEROL SULFATELupin Pharmaceuticals, Inc.973b8686-c6ce-4280-85c4-c1e7ceab3c092025-01-23Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATENuCare Pharmaceuticals,Inc.749992b4-69e0-0cc8-e053-2991aa0aeb252025-01-08Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
ALBUTEROL SULFATEALBUTEROL SULFATEHF Acquisition Co LLC, DBA HealthFirst9d4ef83f-8ca0-811e-e053-2995a90a6d0d2025-01-08Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
ALBUTEROL SULFATEALBUTEROL SULFATEPreferred Pharmaceuticals, Inc.4aafc2dd-744d-4726-828f-70355aee6f702025-01-03Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEProficient Rx LP53eecdef-a7ff-4ca3-a313-d4b9c29c898d2025-01-01Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol Sulfate HFAALBUTEROL SULFATEAdvanced Rx of Tennessee, LLC04c8a345-0a0d-5a01-e063-6294a90a40d22024-12-31Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEAdvanced Rx Pharmacy of Tennessee, LLCf44b325d-0f74-552c-e053-2995a90ac1c92024-12-31Warnings, 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, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PROPYLPARABEN, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR, PARAFFINUMEnergique, Inc.f3db63df-62a4-48d6-92e7-94e4a57015522024-12-20WarningsExact identifier
unii: 368GB5141J
Albuterol Sulfate InhalationALBUTEROL SULFATEAmneal Pharmaceuticals NY LLC2e449282-ee58-4e36-b983-85c4e6f0864d2024-12-20Warnings, Adverse reactionsExact identifier
unii: 021SEF3731

Reported adverse events (FAERS/openFDA)#

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