FDA.reportPublic FDA data

Proventil HFA

Product NDC
42254-004
11-digit product format
422540004
Labeler code
42254
Product ID
42254-004_12d06309-0483-48c6-a9f2-b25dcc31db72
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
Rebel Distributors Corp.
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
E
Listing certified through
2017-12-31
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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
42254-004-672019-09-24C16284748780-19350213a-3de5-c013-e053-90daa90a1393PROVENTIL® HFA (albuterol sulfate) Inhalation Aerosol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-004-67Proventil HFA200 in 1 CANISTERAEROSOL, METERED2001
42254-004-67Proventil HFA1 in 1 CARTONAEROSOL, METERED11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-004-67GM - Gram42254-0041f36ebce-30b8-4627-b63f-854ed187c08812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Albuterol SulfateACTIVE INGREDIENT021SEF3731PROVENTIL HFA (ALBUTEROL SULFATE) AEROSOL, METERED [REBEL DISTRIBUTORS CORP.]1
AlbuterolACTIVE MOIETYQF8SVZ843EPROVENTIL HFA (ALBUTEROL SULFATE) AEROSOL, METERED [REBEL DISTRIBUTORS CORP.]1
alcoholINACTIVE INGREDIENT3K9958V90MPROVENTIL HFA (ALBUTEROL SULFATE) AEROSOL, METERED [REBEL DISTRIBUTORS CORP.]1
NorfluraneINACTIVE INGREDIENTDH9E53K1Y8PROVENTIL HFA (ALBUTEROL SULFATE) AEROSOL, METERED [REBEL DISTRIBUTORS CORP.]1
Oleic acidINACTIVE INGREDIENT2UMI9U37CPPROVENTIL HFA (ALBUTEROL SULFATE) AEROSOL, METERED [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-004PROVENTIL HFA (ALBUTEROL SULFATE) AEROSOL, METERED [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 2 package rows20111118_12d06309-0483-48c6-a9f2-b25dcc31db72.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilPSN12d06309-0483-48c6-a9f2-b25dcc31db721
746763Proventil HFA 90 MCG/INHAL Metered Dose Inhaler, 200 ActuationsPSN12d06309-0483-48c6-a9f2-b25dcc31db721
746763NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [Proventil]SBD12d06309-0483-48c6-a9f2-b25dcc31db721
2123111NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCD12d06309-0483-48c6-a9f2-b25dcc31db721
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilSY12d06309-0483-48c6-a9f2-b25dcc31db721
746763NDA020503 200 ACTUAT Proventil 0.09 MG/ACTUAT Metered Dose InhalerSY12d06309-0483-48c6-a9f2-b25dcc31db721
746763Proventil 0.09 MG/ACTUAT (albuterol sulfate 0.108 MG/ACTUAT from mouthpiece) 200 ACTUAT Metered Dose InhalerSY12d06309-0483-48c6-a9f2-b25dcc31db721
746763Proventil HFA 90 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUATSY12d06309-0483-48c6-a9f2-b25dcc31db721

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-004-6742254000467200 in 1 CANISTERHistorical