NDC 0085-1132

Proventil HFA

Albuterol Sulfate

Proventil HFA is a Respiratory (inhalation) Aerosol, Metered in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Albuterol Sulfate.

Product ID0085-1132_509798c2-1f00-452a-9bb6-37792a3ef226
NDC0085-1132
Product TypeHuman Prescription Drug
Proprietary NameProventil HFA
Generic NameAlbuterol Sulfate
Dosage FormAerosol, Metered
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2018-03-08
Marketing CategoryNDA / NDA
Application NumberNDA020503
Labeler NameMerck Sharp & Dohme Corp.
Substance NameALBUTEROL SULFATE
Active Ingredient Strength108 ug/1
Pharm ClassesAdrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0085-1132-04

1 CANISTER in 1 CARTON (0085-1132-04) > 200 AEROSOL, METERED in 1 CANISTER
Marketing Start Date2018-03-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0085-1132-01 [00085113201]

Proventil HFA AEROSOL, METERED
Marketing CategoryNDA
Application NumberNDA020503
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2001-10-01
Marketing End Date2019-09-30

NDC 0085-1132-02 [00085113202]

Proventil HFA AEROSOL, METERED
Marketing CategoryNDA
Application NumberNDA020503
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2001-10-01
Marketing End Date2019-09-30

NDC 0085-1132-04 [00085113204]

Proventil HFA AEROSOL, METERED
Marketing CategoryNDA
Application NumberNDA020503
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-01-31

Drug Details

Active Ingredients

IngredientStrength
ALBUTEROL SULFATE108 ug/1

OpenFDA Data

SPL SET ID:f454947c-6055-474b-bf35-29a379e01aa3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 745679
  • 746763

    • Pharmacological Class

    • Adrenergic beta2-Agonists [MoA]
    • beta2-Adrenergic Agonist [EPC]

    NDC Crossover Matching brand name "Proventil HFA" or generic name "Albuterol Sulfate"

    NDCBrand NameGeneric Name
    0085-1132Proventil HFAAlbuterol Sulfate
    42254-004Proventil HFAProventil HFA
    50090-0624Proventil HFAProventil HFA
    50090-4326Proventil HFAProventil HFA
    0378-0255Albuterolalbuterol sulfate
    0378-0572Albuterolalbuterol sulfate
    0054-0742Albuterol SulfateAlbuterol Sulfate
    0093-3174Albuterol SulfateAlbuterol Sulfate
    0254-1007Albuterol SulfateAlbuterol Sulfate
    0378-4122Albuterol Sulfatealbuterol sulfate
    0378-4124Albuterol Sulfatealbuterol sulfate
    0378-6991Albuterol Sulfatealbuterol sulfate
    0378-6992Albuterol Sulfatealbuterol sulfate
    0378-7057Albuterol SulfateAlbuterol Sulfate
    0378-7058Albuterol SulfateAlbuterol Sulfate
    0378-8270Albuterol SulfateAlbuterol Sulfate
    0173-0682VENTOLINalbuterol sulfate
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