NDC 0378-7970

Ipratropium Bromide

Ipratropium Bromide

Ipratropium Bromide 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.

Product ID0378-7970_2c5fc3b9-e3f3-4120-947a-815d30502a3a
NDC0378-7970
Product TypeHuman Prescription Drug
Proprietary NameIpratropium Bromide
Generic NameIpratropium Bromide
Dosage FormSolution
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2010-11-09
Marketing CategoryANDA / ANDA
Application NumberANDA075693
Labeler NameMylan Pharmaceuticals Inc.
Substance NameIPRATROPIUM BROMIDE
Active Ingredient Strength1 mg/2.5mL
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-7970-52

1 POUCH in 1 CARTON (0378-7970-52) > 25 AMPULE in 1 POUCH (0378-7970-62) > 2.5 mL in 1 AMPULE
Marketing Start Date2010-11-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-7970-52 [00378797052]

Ipratropium Bromide SOLUTION
Marketing CategoryANDA
Application NumberANDA075693
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-11-09

NDC 0378-7970-93 [00378797093]

Ipratropium Bromide SOLUTION
Marketing CategoryANDA
Application NumberANDA075693
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-11-09

NDC 0378-7970-55 [00378797055]

Ipratropium Bromide SOLUTION
Marketing CategoryANDA
Application NumberANDA075693
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-11-09

NDC 0378-7970-62 [00378797062]

Ipratropium Bromide SOLUTION
Marketing CategoryANDA
Application NumberANDA075693
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-11-09

NDC 0378-7970-91 [00378797091]

Ipratropium Bromide SOLUTION
Marketing CategoryANDA
Application NumberANDA075693
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-11-09

NDC 0378-7970-64 [00378797064]

Ipratropium Bromide SOLUTION
Marketing CategoryANDA
Application NumberANDA075693
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-11-09

NDC 0378-7970-31 [00378797031]

Ipratropium Bromide SOLUTION
Marketing CategoryANDA
Application NumberANDA075693
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-11-09

Drug Details

Active Ingredients

IngredientStrength
IPRATROPIUM BROMIDE.5 mg/2.5mL

OpenFDA Data

SPL SET ID:f625d3e3-c175-4d9a-99ea-dab410b262f1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 836358

    • Pharmacological Class

    • Anticholinergic [EPC]
    • Cholinergic Antagonists [MoA]

    NDC Crossover Matching brand name "Ipratropium Bromide" or generic name "Ipratropium Bromide"

    NDCBrand NameGeneric Name
    0054-0045Ipratropium BromideIpratropium Bromide
    0054-0046Ipratropium BromideIpratropium Bromide
    0378-7970Ipratropium BromideIpratropium Bromide
    0487-9801Ipratropium BromideIpratropium Bromide
    0591-3798Ipratropium BromideIpratropium Bromide
    0781-7157Ipratropium BromideIpratropium Bromide
    16714-526Ipratropium BromideIpratropium Bromide
    16714-527Ipratropium Bromideipratropium bromide
    21695-911Ipratropium BromideIpratropium Bromide
    24208-398Ipratropium bromideIpratropium bromide
    24208-399Ipratropium BromideIpratropium Bromide
    42254-041Ipratropium BromideIpratropium Bromide
    42254-355Ipratropium BromideIpratropium Bromide
    47335-706Ipratropium BromideIpratropium Bromide
    50090-0668Ipratropium BromideIpratropium Bromide
    50090-2566Ipratropium BromideIpratropium Bromide
    50090-4185Ipratropium BromideIpratropium Bromide
    50090-5968Ipratropium Bromideipratropium bromide
    50436-5050Ipratropium BromideIpratropium Bromide
    53217-008Ipratropium BromideIpratropium Bromide
    55154-4351Ipratropium BromideIpratropium Bromide
    60505-0826Ipratropium BromideIpratropium Bromide
    60505-0827Ipratropium Bromideipratropium bromide
    68071-1550Ipratropium BromideIpratropium Bromide
    68071-1737Ipratropium BromideIpratropium Bromide
    68788-6897Ipratropium BromideIpratropium Bromide
    68788-0547Ipratropium BromideIpratropium Bromide
    68788-9775Ipratropium BromideIpratropium Bromide
    70518-1070Ipratropium BromideIpratropium Bromide
    76204-100Ipratropium BromideIpratropium Bromide
    60687-394Ipratropium BromideIpratropium Bromide
    63187-188Ipratropium BromideIpratropium Bromide
    65862-905Ipratropium bromideIpratropium bromide
    70518-2874Ipratropium BromideIpratropium Bromide
    0597-0087Atroventipratropium bromide
    50090-0961Atroventipratropium bromide
    53002-8410Atroventipratropium bromide
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