FDA.reportPublic FDA data

Albuterol Sulfate

Product NDC
50742-393
11-digit product format
507420393
Labeler code
50742
Product ID
50742-393_250b033d-3ed5-c0d1-e063-6394a90a93c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA215571
Marketing category
ANDA
Marketing start
2024-11-01
Substance
ALBUTEROL SULFATE
Active strength
1.25 mg/3mL
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Albuterol Sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALBUTEROL SULFATE1.25 mg/3mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii021SEF3731
Rxcui351136, 351137

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
26005090-31a1-441d-920b-db3101a55d53Product name320250221
1c39b897-7219-42a1-9f3a-ec86cfd7b04bProduct name320250218
0a278166-c8aa-41b6-b4a5-6ac332bde76aProduct name120230718
c76bcd0f-25eb-471e-b970-1956c95c26c5Product name120230425
36390b75-5438-47d3-af60-732a654e9025Product name220220110
387afa72-0c5a-0d6b-ee2c-60c3506659e8Product name620210518
1b8ea3ec-88bd-98ea-c961-00ae340b5b14Product name220200220
3aa5a017-61e9-0c89-adef-13e7964d22f0Product name320171208
c3c27a99-b8bc-4955-841c-26555f58ee7eProduct name120150421
bc98cf6f-a973-7162-5e30-0e7dd8c56bc3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50742-393-05Albuterol Sulfate3 mL in 1 VIALSOLUTION34
50742-393-05Albuterol Sulfate5 in 1 POUCHSOLUTION54
50742-393-25Albuterol Sulfate5 in 1 CARTONSOLUTION54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-393ALBUTEROL SULFATE SOLUTION [INGENUS PHARMACEUTICALS, LLC]4Current NDC, 3 package rows20241102_e14f5fd6-d01a-489d-9baa-61778b1352a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351137albuterol sulfate 0.021 % (0.63 MG/3 ML) Inhalation SolutionPSNe14f5fd6-d01a-489d-9baa-61778b1352a84
351136albuterol sulfate 0.042 % (1.25 MG/3 ML) Inhalation SolutionPSNe14f5fd6-d01a-489d-9baa-61778b1352a84
351137albuterol 0.21 MG/ML Inhalation SolutionSCDe14f5fd6-d01a-489d-9baa-61778b1352a84
351136albuterol 0.417 MG/ML Inhalation SolutionSCDe14f5fd6-d01a-489d-9baa-61778b1352a84
351136albuterol 0.042 % (1.25 MG/3 ML) Inhalation SolutionSYe14f5fd6-d01a-489d-9baa-61778b1352a84
351137albuterol 0.63 MG (albuterol sulfate 0.75 MG) per 3 ML Inhalation SolutionSYe14f5fd6-d01a-489d-9baa-61778b1352a84
351136albuterol 1.25 MG (albuterol sulfate 1.5 MG) per 3 ML Inhalation SolutionSYe14f5fd6-d01a-489d-9baa-61778b1352a84
351137albuterol sulfate 0.021 % (0.63 MG/3 ML) Inhalation SolutionSYe14f5fd6-d01a-489d-9baa-61778b1352a84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50742-393-05507420393053 mL in 1 VIAL3 mlHistorical
50742-393-25507420393255 POUCH in 1 CARTON (50742-393-25) / 5 VIAL in 1 POUCH (50742-393-05) / 3 mL in 1 VIAL5 pouch2024-11-01NoNoCurrent