NDC 0186-1989

PULMICORT RESPULES

Budesonide

PULMICORT RESPULES is a Respiratory (inhalation) Suspension in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Budesonide.

Product ID0186-1989_0220044c-c59b-4373-831f-6fa7828993ec
NDC0186-1989
Product TypeHuman Prescription Drug
Proprietary NamePULMICORT RESPULES
Generic NameBudesonide
Dosage FormSuspension
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2000-09-08
Marketing CategoryNDA / NDA
Application NumberNDA020929
Labeler NameAstraZeneca Pharmaceuticals LP
Substance NameBUDESONIDE
Active Ingredient Strength1 mg/2mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0186-1989-04

6 POUCH in 1 CARTON (0186-1989-04) > 5 AMPULE in 1 POUCH > 2 mL in 1 AMPULE
Marketing Start Date2000-09-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0186-1989-04 [00186198904]

PULMICORT RESPULES SUSPENSION
Marketing CategoryNDA
Application NumberNDA020929
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-09-08

Drug Details

Active Ingredients

IngredientStrength
BUDESONIDE.5 mg/2mL

OpenFDA Data

SPL SET ID:33cd9834-76df-4f26-3fa2-aab6b9eee8f2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 349094
  • 351109
  • 616830
  • 252559
  • 616819
  • 616817
  • Pharmacological Class

    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]

    NDC Crossover Matching brand name "PULMICORT RESPULES" or generic name "Budesonide"

    NDCBrand NameGeneric Name
    0186-1988PULMICORT RESPULESBudesonide
    0186-1989PULMICORT RESPULESBudesonide
    0186-1990PULMICORT RESPULESBudesonide
    0093-6815BudesonideBudesonide
    0093-6816BudesonideBudesonide
    0093-6817BudesonideBudesonide
    0093-7445BudesonideBudesonide
    0115-1687Budesonide InhalationBudesonide
    0115-1689Budesonide InhalationBudesonide
    0186-0916PULMICORTBudesonide
    0186-0917PULMICORTBudesonide

    Trademark Results [PULMICORT RESPULES]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PULMICORT RESPULES
    PULMICORT RESPULES
    78611647 3079539 Live/Registered
    AstraZeneca AB
    2005-04-19
    PULMICORT RESPULES
    PULMICORT RESPULES
    75391323 2502318 Live/Registered
    ASTRA AKTIEBOLAG
    1997-11-17

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