FDA.reportPublic FDA data

Albuterol sulfate

Product NDC
70518-3541
11-digit product format
705183541
Labeler code
70518
Product ID
70518-3541_4f588cfe-721a-363f-e063-6394a90af868
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol sulfate
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
REMEDYREPACK INC.
Application
ANDA209954
Marketing category
ANDA
Marketing start
2022-09-28
Substance
ALBUTEROL SULFATE
Active strength
90 ug/1
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Albuterol sulfate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALBUTEROL SULFATE90 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii021SEF3731
Rxcui2123072

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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
70518-3541-0Albuterol sulfate1 in 1 CARTONAEROSOL, METERED18
70518-3541-0Albuterol sulfate200 in 1 CANISTERAEROSOL, METERED2008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3541ALBUTEROL SULFATE AEROSOL, METERED [REMEDYREPACK INC.]4Current NDC, Legacy NDC, 2 package rows20241121_0cfb6c5d-eac2-4a1c-8a0f-6b00e819adda.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2123072albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProAirPSN0cfb6c5d-eac2-4a1c-8a0f-6b00e819adda8
2123072NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCD0cfb6c5d-eac2-4a1c-8a0f-6b00e819adda8
2123072albuterol 90 MCG/ACTUAT Metered Dose Inhaler, 200 Actuations, generic for ProAirSY0cfb6c5d-eac2-4a1c-8a0f-6b00e819adda8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3541-0705183541001 CANISTER in 1 CARTON (70518-3541-0) / 200 AEROSOL, METERED in 1 CANISTER1 canister2022-09-280000-00-00NoNoCurrent