NDC 0378-9671

Ipratropium Bromide and Albuterol Sulfate

Ipratropium Bromide And Albuterol Sulfate

Ipratropium Bromide and Albuterol Sulfate is a Respiratory (inhalation) Solution in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals, Inc.. The primary component is Ipratropium Bromide; Albuterol Sulfate.

Product ID0378-9671_7cda1cf7-02fb-3da3-e053-2a91aa0a4889
NDC0378-9671
Product TypeHuman Prescription Drug
Proprietary NameIpratropium Bromide and Albuterol Sulfate
Generic NameIpratropium Bromide And Albuterol Sulfate
Dosage FormSolution
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2013-03-01
Marketing CategoryANDA / ANDA
Application NumberANDA202496
Labeler NameMylan Pharmaceuticals, Inc.
Substance NameIPRATROPIUM BROMIDE; ALBUTEROL SULFATE
Active Ingredient Strength1 mg/3mL; mg/3mL
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0378-9671-30

1 POUCH in 1 CARTON (0378-9671-30) > 30 AMPULE in 1 POUCH (0378-9671-64) > 3 mL in 1 AMPULE
Marketing Start Date2013-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-9671-60 [00378967160]

Ipratropium Bromide and Albuterol Sulfate SOLUTION
Marketing CategoryANDA
Application NumberANDA202496
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-03-01

NDC 0378-9671-91 [00378967191]

Ipratropium Bromide and Albuterol Sulfate SOLUTION
Marketing CategoryANDA
Application NumberANDA202496
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-03-01
Marketing End Date2019-05-13

NDC 0378-9671-30 [00378967130]

Ipratropium Bromide and Albuterol Sulfate SOLUTION
Marketing CategoryANDA
Application NumberANDA202496
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-03-01

NDC 0378-9671-98 [00378967198]

Ipratropium Bromide and Albuterol Sulfate SOLUTION
Marketing CategoryANDA
Application NumberANDA202496
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-03-01
Marketing End Date2019-05-13

NDC 0378-9671-64 [00378967164]

Ipratropium Bromide and Albuterol Sulfate SOLUTION
Marketing CategoryANDA
Application NumberANDA202496
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-02-08

NDC 0378-9671-31 [00378967131]

Ipratropium Bromide and Albuterol Sulfate SOLUTION
Marketing CategoryANDA
Application NumberANDA202496
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-03-01

NDC 0378-9671-93 [00378967193]

Ipratropium Bromide and Albuterol Sulfate SOLUTION
Marketing CategoryANDA
Application NumberANDA202496
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-03-01

NDC 0378-9671-58 [00378967158]

Ipratropium Bromide and Albuterol Sulfate SOLUTION
Marketing CategoryANDA
Application NumberANDA202496
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-03-01
Marketing End Date2019-05-13

Drug Details

Active Ingredients

IngredientStrength
IPRATROPIUM BROMIDE.5 mg/3mL

OpenFDA Data

SPL SET ID:23c05e9a-9df5-4978-8831-cf562aa4ba92
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1437702
    • UPC Code
  • 0303789671608
  • 0303789671936
  • 0303789671301

    • Pharmacological Class

    • Anticholinergic [EPC]
    • Cholinergic Antagonists [MoA]
    • Adrenergic beta2-Agonists [MoA]
    • beta2-Adrenergic Agonist [EPC]

    NDC Crossover Matching brand name "Ipratropium Bromide and Albuterol Sulfate" or generic name "Ipratropium Bromide And Albuterol Sulfate"

    NDCBrand NameGeneric Name
    0185-7322Ipratropium Bromide and Albuterol Sulfateipratropium bromide and albuterol sulfate
    0378-9671Ipratropium Bromide and Albuterol SulfateIpratropium Bromide and Albuterol Sulfate
    0487-0201Ipratropium Bromide and Albuterol SulfateIpratropium Bromide and Albuterol Sulfate
    0591-3817Ipratropium Bromide and Albuterol Sulfateipratropium bromide and albuterol sulfate
    0781-7146Ipratropium Bromide and Albuterol SulfateIpratropium Bromide and Albuterol Sulfate
    47335-756Ipratropium Bromide and Albuterol SulfateIpratropium Bromide and Albuterol Sulfate
    50090-1382IPRATROPIUM BROMIDE AND ALBUTEROL SULFATEIpratropium Bromide and Albuterol Sulfate
    50090-1669Ipratropium Bromide and Albuterol SulfateIpratropium Bromide and Albuterol Sulfate
    50090-2567Ipratropium Bromide and Albuterol Sulfateipratropium bromide and albuterol sulfate
    50090-4103IPRATROPIUM BROMIDE AND ALBUTEROL SULFATEIpratropium Bromide and Albuterol Sulfate
    50090-6288Ipratropium Bromide and Albuterol SulfateIpratropium Bromide and Albuterol Sulfate
    55154-4357Ipratropium Bromide and Albuterol SulfateIpratropium Bromide and Albuterol Sulfate
    60429-975IPRATROPIUM BROMIDE AND ALBUTEROL SULFATEIpratropium Bromide and Albuterol Sulfate
    60687-405IPRATROPIUM BROMIDE AND ALBUTEROL SULFATEIpratropium Bromide and Albuterol Sulfate
    63187-529ipratropium bromide and albuterol sulfateipratropium bromide and albuterol sulfate
    65302-047Ipratropium Bromide and Albuterol SulfateIpratropium Bromide and Albuterol Sulfate
    65302-053Ipratropium Bromide and Albuterol SulfateIpratropium Bromide and Albuterol Sulfate
    65862-906Ipratropium Bromide and Albuterol SulfateIpratropium Bromide and Albuterol Sulfate
    68788-7678Ipratropium Bromide and Albuterol SulfateIpratropium Bromide and Albuterol Sulfate
    68788-8103Ipratropium Bromide and Albuterol SulfateIpratropium Bromide and Albuterol Sulfate
    68788-9279ipratropium bromide and albuterol sulfateipratropium bromide and albuterol sulfate
    69097-173Ipratropium Bromide and Albuterol SulfateIpratropium Bromide and Albuterol Sulfate
    69097-840Ipratropium Bromide and Albuterol SulfateIpratropium Bromide and Albuterol Sulfate
    70518-1724Ipratropium Bromide and Albuterol SulfateIpratropium Bromide and Albuterol Sulfate
    70518-1722Ipratropium Bromide and Albuterol SulfateIpratropium Bromide and Albuterol Sulfate
    71152-201Ipratropium Bromide and Albuterol SulfateIpratropium Bromide and Albuterol Sulfate
    71205-051Ipratropium Bromide and Albuterol SulfateIpratropium Bromide and Albuterol Sulfate
    76204-600IPRATROPIUM BROMIDE AND ALBUTEROL SULFATEIPRATROPIUM BROMIDE AND ALBUTEROL SULFATE
    70518-2243Ipratropium Bromide and Albuterol SulfateIpratropium Bromide and Albuterol Sulfate
    70518-2250Ipratropium Bromide and Albuterol SulfateIpratropium Bromide and Albuterol Sulfate
    70518-2351Ipratropium Bromide and Albuterol SulfateIpratropium Bromide and Albuterol Sulfate
    70518-2627Ipratropium Bromide and Albuterol SulfateIpratropium Bromide and Albuterol Sulfate
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.