FDA.reportPublic FDA data

NDC 0378-0255-05 - 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
0378-0255
Requested NDC
0378-0255-05
Package NDCs from labels
0378-0255-01, 0378-0255-05
Manufacturer
Mylan Pharmaceuticals Inc.
Effective date
2020-07-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Albuterol - Mylan Pharmaceuticals Inc.Mylan Pharmaceuticals Inc.2020-07-30HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0255-01EA - Each0378-02552a92a2fd-05c9-4944-87ac-360bff64249612012-07-24
0378-0255-05EA - Each0378-0255511acfd7-97dc-49ba-acb1-bba9e552367e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALBUTEROL SULFATEACTIVE INGREDIENT021SEF3731ALBUTEROL (ALBUTEROL SULFATE) TABLET [MYLAN PHARMACEUTICALS INC.]5
ALBUTEROLACTIVE MOIETYQF8SVZ843EALBUTEROL (ALBUTEROL SULFATE) TABLET [MYLAN PHARMACEUTICALS INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALBUTEROL (ALBUTEROL SULFATE) TABLET [MYLAN PHARMACEUTICALS INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALBUTEROL (ALBUTEROL SULFATE) TABLET [MYLAN PHARMACEUTICALS INC.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JALBUTEROL (ALBUTEROL SULFATE) TABLET [MYLAN PHARMACEUTICALS INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALBUTEROL (ALBUTEROL SULFATE) TABLET [MYLAN PHARMACEUTICALS INC.]5

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 · 135 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
unii: 021SEF3731
AlbuterolALBUTEROLAmneal Pharmaceuticals NY LLC230d66fc-f62c-42a6-adb3-0a0f879c8ad42026-04-14Warnings, Adverse reactionsExact identifier
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
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.