FDA.reportPublic FDA data

Proventil HFA

Product NDC
50090-4326
11-digit product format
500904326
Labeler code
50090
Product ID
50090-4326_83584e7c-47f3-4ba8-a11a-ab3228cbc14c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
A-S Medication Solutions
Application
NDA020503
Marketing category
NDA
Marketing start
2001-10-01
Marketing end
0000-00-00
Substance
ALBUTEROL SULFATE
Active strength
108 ug/1
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
50090-4326-02023-01-30C16284748780-1f386c64a-09bb-0266-e053-dadaa90a7c1aPROVENTIL® HFA (albuterol sulfate) Inhalation Aerosol
50090-4326-12023-01-30C16284748780-1f386c64a-09bb-0266-e053-dadaa90a7c1aPROVENTIL® HFA (albuterol sulfate) Inhalation Aerosol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4326-0Proventil HFA200 in 1 CANISTERAEROSOL, METERED2001
50090-4326-0Proventil HFA1 in 1 CARTONAEROSOL, METERED11
50090-4326-1Proventil HFA1 in 1 CARTONAEROSOL, METERED11
50090-4326-1Proventil HFA200 in 1 CANISTERAEROSOL, METERED2001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4326PROVENTIL HFA (ALBUTEROL SULFATE) AEROSOL, METERED [A-S MEDICATION SOLUTIONS]1Legacy NDC, 4 package rows20190614_1c16cecd-8e1d-43b2-87e9-6d79a81c26a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilPSN1c16cecd-8e1d-43b2-87e9-6d79a81c26a11
746763Proventil HFA 90 MCG/INHAL Metered Dose Inhaler, 200 ActuationsPSN1c16cecd-8e1d-43b2-87e9-6d79a81c26a11
746763NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [Proventil]SBD1c16cecd-8e1d-43b2-87e9-6d79a81c26a11
2123111NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCD1c16cecd-8e1d-43b2-87e9-6d79a81c26a11
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilSY1c16cecd-8e1d-43b2-87e9-6d79a81c26a11
746763NDA020503 200 ACTUAT Proventil 0.09 MG/ACTUAT Metered Dose InhalerSY1c16cecd-8e1d-43b2-87e9-6d79a81c26a11
746763Proventil 0.09 MG/ACTUAT (albuterol sulfate 0.108 MG/ACTUAT from mouthpiece) 200 ACTUAT Metered Dose InhalerSY1c16cecd-8e1d-43b2-87e9-6d79a81c26a11
746763Proventil HFA 90 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUATSY1c16cecd-8e1d-43b2-87e9-6d79a81c26a11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4326-0500904326001 CANISTER in 1 CARTON (50090-4326-0) > 200 AEROSOL, METERED in 1 CANISTER1 canister2019-05-300000-00-00NoNoCurrent
50090-4326-1500904326011 CANISTER in 1 CARTON (50090-4326-1) > 200 AEROSOL, METERED in 1 CANISTER1 canister2019-05-310000-00-00NoNoCurrent