NDC 69543-291

Albuterol

Albuterol

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

Product ID69543-291_668b9bba-eaf1-4250-9943-204e78fa074f
NDC69543-291
Product TypeHuman Prescription Drug
Proprietary NameAlbuterol
Generic NameAlbuterol
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-10-27
Marketing CategoryANDA / ANDA
Application NumberANDA211397
Labeler NameVirtus Pharmaceuticals 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 69543-291-10

100 TABLET in 1 BOTTLE (69543-291-10)
Marketing Start Date2018-10-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69543-291-10 [69543029110]

Albuterol TABLET
Marketing CategoryANDA
Application NumberANDA211397
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-10-27

NDC 69543-291-50 [69543029150]

Albuterol TABLET
Marketing CategoryANDA
Application NumberANDA211397
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-27
Marketing End Date2018-10-27

NDC 69543-291-18 [69543029118]

Albuterol TABLET
Marketing CategoryANDA
Application NumberANDA211397
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-10-27
Marketing End Date2020-08-31

Drug Details

Active Ingredients

IngredientStrength
ALBUTEROL SULFATE4 mg/1

OpenFDA Data

SPL SET ID:3f81d53d-c8b2-46f2-b6c4-dfcc18b5ae00
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197316
  • 197318
  • UPC Code
  • 0369543291109
  • 0369543290102
  • Pharmacological Class

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

    Medicade Reported Pricing

    69543029118 ALBUTEROL SULFATE 4 MG TAB

    Pricing Unit: EA | Drug Type:

    69543029110 ALBUTEROL SULFATE 4 MG TAB

    Pricing Unit: EA | Drug Type:

    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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