NDC 0487-9801

Ipratropium Bromide

Ipratropium Bromide

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

Product ID0487-9801_82f9966e-f615-23f2-e053-2991aa0a0844
NDC0487-9801
Product TypeHuman Prescription Drug
Proprietary NameIpratropium Bromide
Generic NameIpratropium Bromide
Dosage FormSolution
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2001-09-27
Marketing CategoryANDA / ANDA
Application NumberANDA075562
Labeler NameNephron SC 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 0487-9801-01

30 POUCH in 1 CARTON (0487-9801-01) > 1 VIAL, SINGLE-DOSE in 1 POUCH > 2.5 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2001-09-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0487-9801-01 [00487980101]

Ipratropium Bromide SOLUTION
Marketing CategoryANDA
Application NumberANDA075562
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2001-09-27

NDC 0487-9801-60 [00487980160]

Ipratropium Bromide SOLUTION
Marketing CategoryANDA
Application NumberANDA075562
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2001-09-27

NDC 0487-9801-25 [00487980125]

Ipratropium Bromide SOLUTION
Marketing CategoryANDA
Application NumberANDA075562
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2001-09-27

NDC 0487-9801-02 [00487980102]

Ipratropium Bromide SOLUTION
Marketing CategoryANDA
Application NumberANDA075562
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2001-09-27

NDC 0487-9801-30 [00487980130]

Ipratropium Bromide SOLUTION
Marketing CategoryANDA
Application NumberANDA075562
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2001-09-27

Drug Details

Active Ingredients

IngredientStrength
IPRATROPIUM BROMIDE.5 mg/2.5mL

OpenFDA Data

SPL SET ID:db8095db-d1fd-4099-9fb1-d1ad4e284976
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 836358
    • UPC Code
  • 0304879801011

    • Pharmacological Class

    • Anticholinergic [EPC]
    • Cholinergic Antagonists [MoA]
    • 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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.