NDC 0378-6991

Albuterol Sulfate

Albuterol Sulfate

Albuterol Sulfate is a Respiratory (inhalation) Solution in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Albuterol Sulfate.

Product ID0378-6991_0344b447-b8b0-4179-b336-635f9f37c00f
NDC0378-6991
Product TypeHuman Prescription Drug
Proprietary NameAlbuterol Sulfate
Generic NameAlbuterol Sulfate
Dosage FormSolution
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2009-10-30
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA020949
Labeler NameMylan Pharmaceuticals Inc.
Substance NameALBUTEROL SULFATE
Active Ingredient Strength1 mg/3mL
Pharm ClassesAdrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-6991-52

5 POUCH in 1 CARTON (0378-6991-52) > 5 VIAL in 1 POUCH (0378-6991-98) > 3 mL in 1 VIAL
Marketing Start Date2009-10-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-6991-52 [00378699152]

Albuterol Sulfate SOLUTION
Marketing CategoryNDA authorized generic
Application NumberNDA020949
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-10-30

Drug Details

Active Ingredients

IngredientStrength
ALBUTEROL SULFATE.75 mg/3mL

OpenFDA Data

SPL SET ID:fa5ebedb-069c-4a1e-9a25-b6fa957e6c2b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351137
  • 351136
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    68071-4048Albuterol SulfateAlbuterol Sulfate
    68071-4199Albuterol SulfateAlbuterol Sulfate
    68071-4226Albuterol SulfateAlbuterol Sulfate
    68071-4543Albuterol SulfateAlbuterol Sulfate
    68071-4754Albuterol SulfateAlbuterol Sulfate
    68084-949albuterol sulfatealbuterol sulfate
    68084-952albuterol sulfatealbuterol sulfate
    68151-0661Albuterol SulfateAlbuterol Sulfate
    68258-8001Albuterol SulfateAlbuterol Sulfate
    0472-0825Albuterol SulfateAlbuterol Sulfate
    0487-9904Albuterol SulfateAlbuterol Sulfate
    0487-9501Albuterol SulfateAlbuterol Sulfate
    0487-9901Albuterol SulfateAlbuterol Sulfate
    0487-0301Albuterol SulfateAlbuterol Sulfate
    68788-0177albuterol sulfatealbuterol sulfate
    68788-0255albuterol sulfatealbuterol sulfate
    68788-0825Albuterol SulfateAlbuterol Sulfate
    68788-0134Albuterol SulfateAlbuterol Sulfate
    68788-7390Albuterol SulfateAlbuterol Sulfate
    68788-9298Albuterol SulfateAlbuterol Sulfate
    68788-9782Albuterol SulfateAlbuterol Sulfate
    0591-3467Albuterol SulfateAlbuterol Sulfate
    0591-3468Albuterol SulfateAlbuterol Sulfate
    70518-1095Albuterol SulfateAlbuterol Sulfate
    0591-3797Albuterol SulfateAlbuterol Sulfate
    71872-7054Albuterol SulfateAlbuterol Sulfate
    76204-200Albuterol SulfateAlbuterol Sulfate
    0781-7155Albuterol SulfateAlbuterol Sulfate
    17856-0740Albuterol SulfateAlbuterol Sulfate
    21695-245Albuterol SulfateAlbuterol Sulfate
    21695-350Albuterol SulfateAlbuterol Sulfate
    21695-332Albuterol SulfateAlbuterol Sulfate
    24208-347Albuterol SulfateAlbuterol Sulfate
    33261-789Albuterol SulfateAlbuterol Sulfate
    50090-0516Albuterol SulfateAlbuterol Sulfate
    50383-740Albuterol SulfateAlbuterol Sulfate
    50383-741Albuterol SulfateAlbuterol Sulfate
    51662-1267ALBUTEROL SULFATEALBUTEROL SULFATE
    51662-1202ALBUTEROL SULFATEALBUTEROL SULFATE
    53489-177albuterol sulfatealbuterol sulfate

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