NDC 0378-0572

Albuterol

Albuterol Sulfate

Albuterol is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Albuterol Sulfate.

Product ID0378-0572_31c0b117-8f51-4a45-9d5d-c6488e73751c
NDC0378-0572
Product TypeHuman Prescription Drug
Proprietary NameAlbuterol
Generic NameAlbuterol Sulfate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1991-01-17
Marketing CategoryANDA / ANDA
Application NumberANDA072894
Labeler NameMylan Pharmaceuticals Inc.
Substance NameALBUTEROL SULFATE
Active Ingredient Strength4 mg/1
Pharm ClassesAdrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-0572-01

100 TABLET in 1 BOTTLE, PLASTIC (0378-0572-01)
Marketing Start Date1991-01-17
Marketing End Date2023-02-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-0572-05 [00378057205]

Albuterol TABLET
Marketing CategoryANDA
Application NumberANDA072894
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1991-01-17
Marketing End Date2020-06-30

NDC 0378-0572-01 [00378057201]

Albuterol TABLET
Marketing CategoryANDA
Application NumberANDA072894
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1991-01-17

Drug Details

Active Ingredients

IngredientStrength
ALBUTEROL SULFATE4 mg/1

OpenFDA Data

SPL SET ID:1c1f3881-2b68-4bdb-a12f-8134fe8ba961
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197316
  • 197318
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0378-0255Albuterolalbuterol sulfate
    0378-0572Albuterolalbuterol sulfate
    69238-1344AlbuterolAlbuterol
    69238-1345AlbuterolAlbuterol
    69339-127AlbuterolAlbuterol
    69339-126AlbuterolAlbuterol
    69543-290AlbuterolAlbuterol
    69543-291AlbuterolAlbuterol
    21695-198AlbuterolAlbuterol
    51079-658AlbuterolAlbuterol
    51079-657AlbuterolAlbuterol
    55289-045AlbuterolAlbuterol
    64980-443AlbuterolAlbuterol
    64980-442AlbuterolAlbuterol
    70954-078AlbuterolAlbuterol
    70954-079AlbuterolAlbuterol
    70710-1062AlbuterolAlbuterol
    70710-1061AlbuterolAlbuterol
    70771-1511AlbuterolAlbuterol
    59651-333AlbuterolAlbuterol
    59651-334AlbuterolAlbuterol
    70771-1512AlbuterolAlbuterol
    75834-273AlbuterolAlbuterol
    75834-274AlbuterolAlbuterol
    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
    0085-1132Proventil HFAAlbuterol Sulfate
    0173-0682VENTOLINalbuterol sulfate

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