ALBUTEROL SULFATE

Product NDC
76519-1171
11-digit product format
765191171
Labeler code
76519
Product ID
76519-1171_874bcb9b-3b52-1375-e053-2a95a90ad559
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALBUTEROL SULFATE
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
H.J. Harkins Company, Inc.
Application
NDA021457
Marketing category
NDA
Marketing start
2019-03-25
Marketing end
0000-00-00
Substance
ALBUTEROL SULFATE
Active strength
90 ug/g
Pharmacologic classes
Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
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
76519-1171-02022-01-28C16284748780-1d6a99b39-848c-a426-e053-dadaa90af4c21171 ALBUTEROL (PROAIR)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76519-1171-0ALBUTEROL SULFATEHFA8.5 g in 1 INHALERAEROSOL, METERED8.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76519-1171ALBUTEROL SULFATE HFA (ALBUTEROL SULFATE) AEROSOL, METERED [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 1 package rows20190425_874bcb9b-3b51-1375-e053-2a95a90ad559.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2123072albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProAirPSN874bcb9b-3b51-1375-e053-2a95a90ad5591
2123072NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCD874bcb9b-3b51-1375-e053-2a95a90ad5591
2123072albuterol 90 MCG/ACTUAT Metered Dose Inhaler, 200 Actuations, generic for ProAirSY874bcb9b-3b51-1375-e053-2a95a90ad5591

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76519-1171-0765191171008.5 g in 1 INHALER (76519-1171-0) 8.5 g2019-03-250000-00-00NoNoCurrent