NDC 0591-3467

Albuterol Sulfate

Albuterol Sulfate

Albuterol Sulfate is a Intrabronchial Solution in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Albuterol Sulfate.

Product ID0591-3467_822389a6-a2ba-498a-bf4e-ba76319ea127
NDC0591-3467
Product TypeHuman Prescription Drug
Proprietary NameAlbuterol Sulfate
Generic NameAlbuterol Sulfate
Dosage FormSolution
Route of AdministrationINTRABRONCHIAL
Marketing Start Date2007-09-25
Marketing CategoryANDA / ANDA
Application NumberANDA077772
Labeler NameActavis Pharma, 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 0591-3467-53

5 POUCH in 1 CARTON (0591-3467-53) > 5 VIAL in 1 POUCH > 3 mL in 1 VIAL
Marketing Start Date2007-09-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0591-3467-72 [00591346772]

Albuterol Sulfate SOLUTION
Marketing CategoryANDA
Application NumberANDA077772
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-07-31
Marketing End Date2012-08-16

NDC 0591-3467-53 [00591346753]

Albuterol Sulfate SOLUTION
Marketing CategoryANDA
Application NumberANDA077772
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2007-09-25

NDC 0591-3467-03 [00591346703]

Albuterol Sulfate SOLUTION
Marketing CategoryANDA
Application NumberANDA077772
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-07-31
Marketing End Date2012-08-16

Drug Details

Active Ingredients

IngredientStrength
ALBUTEROL SULFATE.63 mg/3mL

OpenFDA Data

SPL SET ID:ab1cbed4-50c4-4769-9947-1927333f278c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351137
  • 351136
  • 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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