NDC 53217-008

Ipratropium Bromide

Ipratropium Bromide

Ipratropium Bromide is a Respiratory (inhalation) Solution in the Human Prescription Drug category. It is labeled and distributed by Aidarex Pharmaceuticals Llc. The primary component is Ipratropium Bromide.

Product ID53217-008_3a79526b-bcfe-4635-82a6-73cafe9b13eb
NDC53217-008
Product TypeHuman Prescription Drug
Proprietary NameIpratropium Bromide
Generic NameIpratropium Bromide
Dosage FormSolution
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2011-02-01
Marketing CategoryANDA / ANDA
Application NumberANDA075693
Labeler NameAidarex Pharmaceuticals LLC
Substance NameIPRATROPIUM BROMIDE
Active Ingredient Strength1 mg/2.5mL
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53217-008-01

2 POUCH in 1 CARTON (53217-008-01) > 30 AMPULE in 1 POUCH > 2.5 mL in 1 AMPULE
Marketing Start Date2011-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53217-008-01 [53217000801]

Ipratropium Bromide SOLUTION
Marketing CategoryANDA
Application NumberANDA075693
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-02-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
IPRATROPIUM BROMIDE.5 mg/2.5mL

OpenFDA Data

SPL SET ID:769febba-671d-476b-b0c8-71489a2f9d20
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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