FDA.reportPublic FDA data

albuterol sulfate

Product NDC
68071-5206
11-digit product format
680715206
Labeler code
68071
Product ID
68071-5206_d773560c-5b72-b368-e053-2995a90aea9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
albuterol sulfate
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA203760
Marketing category
ANDA
Marketing start
2020-02-26
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
2023-12-31
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
68071-5206-22024-01-30C16284748780-1d6a99b39-bbae-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use Albuterol Sulfate Inhalation Aerosol safely and effectively. See full prescribing information for Albuterol Sulfate Inhalation Aerosol . Albuterol Sulfate Inhalation Aerosol Initial U.S. Approval: 1981
68071-5206-22022-02-07C16284748780-1d6a99b39-bbae-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use Albuterol Sulfate Inhalation Aerosol safely and effectively. See full prescribing information for Albuterol Sulfate Inhalation Aerosol . Albuterol Sulfate Inhalation Aerosol Initial U.S. Approval: 1981
68071-5206-22022-01-28C16284748780-1d6a99b39-bbae-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use Albuterol Sulfate Inhalation Aerosol safely and effectively. See full prescribing information for Albuterol Sulfate Inhalation Aerosol . Albuterol Sulfate Inhalation Aerosol Initial U.S. Approval: 1981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-5206-2albuterol sulfate200 in 1 INHALERAEROSOL, METERED2002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5206ALBUTEROL SULFATE AEROSOL, METERED [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 1 package rows20220208_a0ff696c-9fb9-64c5-e053-2a95a90a3a81.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2123072albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProAirPSNa0ff696c-9fb9-64c5-e053-2a95a90a3a812
2123072NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCDa0ff696c-9fb9-64c5-e053-2a95a90a3a812
2123072albuterol 90 MCG/ACTUAT Metered Dose Inhaler, 200 Actuations, generic for ProAirSYa0ff696c-9fb9-64c5-e053-2a95a90a3a812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-5206-268071520602200 AEROSOL, METERED in 1 INHALER (68071-5206-2) 2020-03-160000-00-00NoNoCurrent