FDA.reportPublic FDA data

Albuterol Sulfate

Product NDC
53002-2584
11-digit product format
530022584
Labeler code
53002
Product ID
53002-2584_df2b6491-a28d-4c73-8b5c-36fcb940976f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
albuterol sulfate
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
RPK Pharmaceuticals, Inc.
Application
NDA020983
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-01-15
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-2584-22025-01-30C16284748780-1f386c64a-0559-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Albuterol Sulfate HFA safely and effectively. See full prescribing information for Albuterol Sulfate HFA. Albuterol Sulfate HFA Inhalation Aerosol, for oral inhalation use Initial U.S. Approval: 1981
53002-2584-22023-06-07C16284748780-1f386c64a-0559-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Albuterol Sulfate HFA safely and effectively. See full prescribing information for Albuterol Sulfate HFA. Albuterol Sulfate HFA Inhalation Aerosol, for oral inhalation use Initial U.S. Approval: 1981
53002-2584-22023-01-30C16284748780-1f386c64a-0559-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Albuterol Sulfate HFA safely and effectively. See full prescribing information for Albuterol Sulfate HFA. Albuterol Sulfate HFA Inhalation Aerosol, for oral inhalation use Initial U.S. Approval: 1981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-2584-2Albuterol SulfateHFA200 in 1 INHALERAEROSOL, METERED2003
53002-2584-2Albuterol SulfateHFA1 in 1 CARTONAEROSOL, METERED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2584ALBUTEROL SULFATE HFA (ALBUTEROL SULFATE) AEROSOL, METERED [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 2 package rows20230609_b1d90674-5e9e-4295-aea7-28a9c84f3d74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2123076albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuation, generic for VentolinPSNb1d90674-5e9e-4295-aea7-28a9c84f3d743
2123076NDA020983 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCDb1d90674-5e9e-4295-aea7-28a9c84f3d743
2123076albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuation, generic for VentolinSYb1d90674-5e9e-4295-aea7-28a9c84f3d743

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-2584-2530022584021 INHALER in 1 CARTON (53002-2584-2) > 200 AEROSOL, METERED in 1 INHALER1 inhaler2019-01-150000-00-00NoNoCurrent