NDC 63187-204

Albuterol Sulfate

Albuterol Sulfate

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

Product ID63187-204_162c7ed8-7caa-49eb-8ccc-77f81bce4f8b
NDC63187-204
Product TypeHuman Prescription Drug
Proprietary NameAlbuterol Sulfate
Generic NameAlbuterol Sulfate
Dosage FormSolution
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date1997-09-17
Marketing CategoryANDA / ANDA
Application NumberANDA074880
Labeler NameProficient Rx LP
Substance NameALBUTEROL SULFATE
Active Ingredient Strength3 mg/3mL
Pharm ClassesAdrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 63187-204-25

1 POUCH in 1 CARTON (63187-204-25) > 25 VIAL, SINGLE-DOSE in 1 POUCH > 3 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2018-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63187-204-25 [63187020425]

Albuterol Sulfate SOLUTION
Marketing CategoryANDA
Application NumberANDA074880
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-01

Drug Details

Active Ingredients

IngredientStrength
ALBUTEROL SULFATE2.5 mg/3mL

OpenFDA Data

SPL SET ID:d3d2ab1e-8f91-4a4d-aa6b-5a57f59ad56b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 630208
  • Pharmacological Class

    • 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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