FDA.reportPublic FDA data

Proventil HFA

Product NDC
0085-1132
11-digit product format
000851132
Labeler code
0085
Product ID
0085-1132_bd0c720f-c140-401e-e053-2a95a90a970d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
Merck Sharp & Dohme Corp.
Application
NDA020503
Marketing category
NDA
Marketing start
2018-03-08
Marketing end
2022-07-31
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
0000-00-00
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
0085-1132-012020-09-27C16284748780-1ab0e2407-28cc-f274-e053-dbdaa90a6471PROVENTIL® HFA (albuterol sulfate) Inhalation Aerosol
0085-1132-022020-09-27C16284748780-1ab0e2407-28cc-f274-e053-dbdaa90a6471PROVENTIL® HFA (albuterol sulfate) Inhalation Aerosol
0085-1132-012020-09-25C16284748780-1ab0e2407-28cc-f274-e053-dbdaa90a6471PROVENTIL® HFA (albuterol sulfate) Inhalation Aerosol
0085-1132-022020-09-25C16284748780-1ab0e2407-28cc-f274-e053-dbdaa90a6471PROVENTIL® HFA (albuterol sulfate) Inhalation Aerosol
0085-1132-012020-07-22C16284748780-1ab0e2407-28cc-f274-e053-dbdaa90a6471PROVENTIL® HFA (albuterol sulfate) Inhalation Aerosol
0085-1132-022020-07-22C16284748780-1ab0e2407-28cc-f274-e053-dbdaa90a6471PROVENTIL® HFA (albuterol sulfate) Inhalation Aerosol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0085-1132-01Proventil HFA200 in 1 CANISTERAEROSOL, METERED20017
0085-1132-01Proventil HFA1 in 1 CARTONAEROSOL, METERED117
0085-1132-02Proventil HFA1 in 1 CARTONAEROSOL, METERED117
0085-1132-02Proventil HFA100 in 1 CANISTERAEROSOL, METERED10017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0085-1132PROVENTIL HFA (ALBUTEROL SULFATE) AEROSOL, METERED [MERCK SHARP & DOHME CORP.]17Legacy NDC, 4 package rows20191008_f454947c-6055-474b-bf35-29a379e01aa3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilPSNf454947c-6055-474b-bf35-29a379e01aa317
746763Proventil HFA 90 MCG/INHAL Metered Dose Inhaler, 200 ActuationsPSNf454947c-6055-474b-bf35-29a379e01aa317
746763NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [Proventil]SBDf454947c-6055-474b-bf35-29a379e01aa317
2123111NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCDf454947c-6055-474b-bf35-29a379e01aa317
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilSYf454947c-6055-474b-bf35-29a379e01aa317
746763NDA020503 200 ACTUAT Proventil 0.09 MG/ACTUAT Metered Dose InhalerSYf454947c-6055-474b-bf35-29a379e01aa317
746763Proventil 0.09 MG/ACTUAT (albuterol sulfate 0.108 MG/ACTUAT from mouthpiece) 200 ACTUAT Metered Dose InhalerSYf454947c-6055-474b-bf35-29a379e01aa317
746763Proventil HFA 90 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUATSYf454947c-6055-474b-bf35-29a379e01aa317
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilPSN12d06309-0483-48c6-a9f2-b25dcc31db721
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilPSNcb4f1002-9372-4fac-aea3-99142f93dd371
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 ActuationsPSN12d06309-0483-48c6-a9f2-b25dcc31db721
746763Proventil HFA 90 MCG/INHAL Metered Dose Inhaler, 200 ActuationsPSNcb4f1002-9372-4fac-aea3-99142f93dd371
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]SBD12d06309-0483-48c6-a9f2-b25dcc31db721
746763NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [Proventil]SBDcb4f1002-9372-4fac-aea3-99142f93dd371
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
2123111NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCD12d06309-0483-48c6-a9f2-b25dcc31db721
2123111NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCDcb4f1002-9372-4fac-aea3-99142f93dd371
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilSYcb4f1002-9372-4fac-aea3-99142f93dd371
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilSY1c16cecd-8e1d-43b2-87e9-6d79a81c26a11
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 InhalerSYcb4f1002-9372-4fac-aea3-99142f93dd371
746763NDA020503 200 ACTUAT Proventil 0.09 MG/ACTUAT Metered Dose InhalerSY1c16cecd-8e1d-43b2-87e9-6d79a81c26a11
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 InhalerSYcb4f1002-9372-4fac-aea3-99142f93dd371
746763Proventil 0.09 MG/ACTUAT (albuterol sulfate 0.108 MG/ACTUAT from mouthpiece) 200 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 InhalerSY12d06309-0483-48c6-a9f2-b25dcc31db721
746763Proventil HFA 90 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUATSY12d06309-0483-48c6-a9f2-b25dcc31db721
746763Proventil HFA 90 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUATSYcb4f1002-9372-4fac-aea3-99142f93dd371
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
0085-1132-0100085113201200 in 1 CANISTERHistorical
0085-1132-02000851132021 in 1 CARTONHistorical
0085-1132-04000851132041 CANISTER in 1 CARTON (0085-1132-04) > 200 AEROSOL, METERED in 1 CANISTER1 canister2018-03-080000-00-00NoNoCurrent