NDC 0378-4122

Albuterol Sulfate

Albuterol Sulfate

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

Product ID0378-4122_d9cf9a6d-6f4d-466d-bea2-c006d33085f8
NDC0378-4122
Product TypeHuman Prescription Drug
Proprietary NameAlbuterol Sulfate
Generic NameAlbuterol Sulfate
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2007-01-30
Marketing CategoryANDA / ANDA
Application NumberANDA078092
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 Through2019-12-31

Packaging

NDC 0378-4122-01

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4122-01)
Marketing Start Date2007-01-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-4122-01 [00378412201]

Albuterol Sulfate TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078092
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-01-30

NDC 0378-4122-05 [00378412205]

Albuterol Sulfate TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078092
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-01-30
Marketing End Date2015-02-02

Drug Details

Active Ingredients

IngredientStrength
ALBUTEROL SULFATE4 mg/1

OpenFDA Data

SPL SET ID:99d6ba1a-1599-48a3-8dbd-a8b06af20fe1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 359144
  • 359145
  • 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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