ALBUTEROL SULFATE

Product NDC
76519-1175
11-digit product format
765191175
Labeler code
76519
Product ID
76519-1175_87747f82-9009-ab34-e053-2995a90a6808
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALBUTEROL SULFATE
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
H.J. Harkins Company, Inc.
Application
NDA020983
Marketing category
NDA AUTHORIZED GENERIC
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
76519-1175-02022-01-28C16284748780-1d6a99b39-6a8a-a426-e053-dadaa90af4c21175 ALBUTEROL (VENTOLIN)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76519-1175-0ALBUTEROL SULFATEHFA18 g in 1 INHALERAEROSOL, METERED181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76519-1175ALBUTEROL SULFATE HFA (ALBUTEROL SULFATE) AEROSOL, METERED [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 1 package rows20190501_87747f82-9008-ab34-e053-2995a90a6808.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2123076albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuation, generic for VentolinPSN87747f82-9008-ab34-e053-2995a90a68081
2123076NDA020983 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCD87747f82-9008-ab34-e053-2995a90a68081
2123076albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuation, generic for VentolinSY87747f82-9008-ab34-e053-2995a90a68081

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76519-1175-07651911750018 g in 1 INHALER (76519-1175-0) 18 g2019-03-250000-00-00NoNoCurrent