NDC 69238-1345

Albuterol

Albuterol

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

Product ID69238-1345_101820cf-5e90-4b75-ac2f-c5300e2dcdfb
NDC69238-1345
Product TypeHuman Prescription Drug
Proprietary NameAlbuterol
Generic NameAlbuterol
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-05-24
Marketing CategoryANDA / ANDA
Application NumberANDA208804
Labeler NameAmneal Pharmaceuticals NY LLC
Substance NameALBUTEROL SULFATE
Active Ingredient Strength4 mg/1
Pharm ClassesAdrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 69238-1345-5

500 BOTTLE in 1 BOTTLE (69238-1345-5) > 100 TABLET in 1 BOTTLE (69238-1345-1)
Marketing Start Date2018-05-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69238-1345-1 [69238134501]

Albuterol TABLET
Marketing CategoryANDA
Application NumberANDA208804
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-05-24

NDC 69238-1345-5 [69238134505]

Albuterol TABLET
Marketing CategoryANDA
Application NumberANDA208804
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-24

Drug Details

Active Ingredients

IngredientStrength
ALBUTEROL SULFATE4 mg/1

OpenFDA Data

SPL SET ID:230d66fc-f62c-42a6-adb3-0a0f879c8ad4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197316
  • 197318
  • Pharmacological Class

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

    Medicade Reported Pricing

    69238134501 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.