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 2 of 7 · 134 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Albuterol SulfateALBUTEROL SULFATESportpharm LLCe31d8d13-ac19-4738-97d4-d7790ce2e8e32026-04-24Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol sulfateALBUTEROL SULFATESportpharm LLC32d954ee-9790-4beb-95db-72dbf8efa6392026-04-24Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
Albuterol SulfateALBUTEROL SULFATECardinal Health 107, LLCd2132c1c-0f90-4c6f-afc0-f3814b6a7e5c2026-04-20Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
albuterol sulfateALBUTEROL SULFATEGolden State Medical Supply, Inc.a22af54a-c010-ab8b-e053-2a95a90a88622026-04-15Warnings, Adverse reactionsExact identifier
rxcui: 197316
rxcui: 197318
unii: 021SEF3731
AlbuterolALBUTEROLAmneal Pharmaceuticals NY LLC230d66fc-f62c-42a6-adb3-0a0f879c8ad42026-04-14Warnings, Adverse reactionsExact identifier
application number: ANDA208804
ndc (package): 69238-1344-1
ndc (package): 69238-1345-5
ndc (package): 69238-1344-5
ndc (package): 69238-1345-1
ndc (product): 69238-1344
ndc (product): 69238-1345
ndc11 (package): 69238134401
rxcui: 197316
rxcui: 197318
spl id: efcb5cab-b9c0-4ef9-84fc-5f321c13a0ed
spl set id: 230d66fc-f62c-42a6-adb3-0a0f879c8ad4
unii: 021SEF3731
Albuterol sulfateALBUTEROL SULFATEREMEDYREPACK INC.0cfb6c5d-eac2-4a1c-8a0f-6b00e819adda2026-04-13Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Ipratropium Bromide and Albuterol SulfateIPRATROPIUM BROMIDE AND ALBUTEROL SULFATESun Pharmaceutical Industries, Inc.38f9a201-3954-4370-8e71-7ec2df88a1ff2026-04-09Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATESun Pharmaceutical Industries, Inc.bb538b7d-e390-419a-9404-a57c1db4a4472026-04-09Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATECardinal Health 107, LLC6ec88f64-66a2-4ca9-9913-c192fc33f88b2026-04-08Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATENephron Pharmaceuticals Corporation285a656c-f77f-4e77-b0a8-a0e9c901803f2026-04-06Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
albuterol sulfateALBUTEROL SULFATESun Pharmaceutical Industries, Inc.87b8cd3c-2849-4b50-b63e-9ea379165c072026-03-16Warnings, Adverse reactionsExact identifier
rxcui: 197316
rxcui: 197318
unii: 021SEF3731
AlbuterolALBUTEROLMylan Pharmaceuticals Inc.9e6e982b-7dfe-45b8-aa76-754e8d2a8ef62026-03-15Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEPreferred Pharmaceuticals Inc.c90e80b2-882e-4c0c-bfac-d67eb1da724d2026-02-16Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEMylan Pharmaceuticals Inc.5329614f-ae0b-4854-bb6f-ea0b7dae87c02026-02-10Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol Sulate HFAALBUTEROL SULFATEREMEDYREPACK INC.77d34a3c-ccc6-420a-ad31-a1af55f7de762026-01-30Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATEIPRATROPIUM BROMIDE AND ALBUTEROL SULFATEGolden State Medical Supply, Inc.2ebc820b-a423-46ef-8eba-9fbc93daff442026-01-28Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEPreferred Pharmaceuticals Inc.1f0bf143-66d4-4a39-b2d1-a5c460ffdcf92026-01-22Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
VENTOLIN HFAALBUTEROL SULFATEREMEDYREPACK INC.2ed73618-be3a-4331-9509-6401258f791f2026-01-19Warnings, Adverse reactionsExact identifier
unii: 021SEF3731

Reported adverse events (FAERS/openFDA)#

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