NDC 70954-079

Albuterol

Albuterol

Albuterol is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Novitium Pharma Llc. The primary component is Albuterol Sulfate.

Product ID70954-079_c22ec856-4582-4b65-9f41-6f9f16bdae37
NDC70954-079
Product TypeHuman Prescription Drug
Proprietary NameAlbuterol
Generic NameAlbuterol
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-10-30
Marketing CategoryANDA / ANDA
Application NumberANDA211397
Labeler NameNovitium Pharma LLC
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 70954-079-10

100 TABLET in 1 BOTTLE (70954-079-10)
Marketing Start Date2018-10-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70954-079-20 [70954007920]

Albuterol TABLET
Marketing CategoryANDA
Application NumberANDA211397
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-30

NDC 70954-079-10 [70954007910]

Albuterol TABLET
Marketing CategoryANDA
Application NumberANDA211397
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-30

Drug Details

Active Ingredients

IngredientStrength
ALBUTEROL SULFATE4 mg/1

OpenFDA Data

SPL SET ID:c22ec856-4582-4b65-9f41-6f9f16bdae37
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197316
  • 197318
  • UPC Code
  • 0370954001102
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0378-0255Albuterolalbuterol sulfate
    0378-0572Albuterolalbuterol sulfate
    21695-198AlbuterolAlbuterol
    51079-657Albuterolalbuterol
    51079-658Albuterolalbuterol
    55289-045Albuterolalbuterol sulfate
    59651-333AlbuterolAlbuterol
    59651-334AlbuterolAlbuterol
    63629-2611Albuterolalbuterol
    64980-442Albuterolalbuterol
    64980-443Albuterolalbuterol
    69238-1344AlbuterolAlbuterol
    69238-1345AlbuterolAlbuterol
    69339-126Albuterolalbuterol sulfate
    69339-127Albuterolalbuterol sulfate
    69543-290AlbuterolAlbuterol
    69543-291AlbuterolAlbuterol
    70710-1061AlbuterolAlbuterol
    70710-1062AlbuterolAlbuterol
    70954-078AlbuterolAlbuterol
    70954-079AlbuterolAlbuterol
    70771-1511AlbuterolAlbuterol
    70771-1512AlbuterolAlbuterol
    75834-273AlbuterolAlbuterol
    75834-274AlbuterolAlbuterol
    66689-100Albuterol SulfateAlbuterol

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