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 ID: 0186-1989_0220044c-c59b-4373-831f-6fa7828993ec
• NDC: 0186-1989
• Product Type: Human Prescription Drug
• Proprietary Name: PULMICORT RESPULES
• Generic Name: Budesonide
• Dosage Form: Suspension
• Route of Administration: RESPIRATORY (INHALATION)
• Marketing Start Date: 2000-09-08
• Marketing Category: NDA / NDA
• Application Number: NDA020929
• Labeler Name: AstraZeneca Pharmaceuticals LP
• Substance Name: BUDESONIDE
• Active Ingredient Strength: 1 mg/2mL
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

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 Date: 2000-09-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0186-1989-04 [00186198904]

PULMICORT RESPULES SUSPENSION

• Marketing Category: NDA
• Application Number: NDA020929
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2000-09-08

Drug Details

Active Ingredients

Ingredient	Strength
BUDESONIDE	.5 mg/2mL

OpenFDA Data

• SPL SET ID: 33cd9834-76df-4f26-3fa2-aab6b9eee8f2
• Manufacturer:
  • AstraZeneca Pharmaceuticals LP
• UNII:
  • Q3OKS62Q6X
• 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"

NDC	Brand Name	Generic Name
0186-1988	PULMICORT RESPULES	Budesonide
0186-1989	PULMICORT RESPULES	Budesonide
0186-1990	PULMICORT RESPULES	Budesonide
0093-6815	Budesonide	Budesonide
0093-6816	Budesonide	Budesonide
0093-6817	Budesonide	Budesonide
0093-7445	Budesonide	Budesonide
0115-1687	Budesonide Inhalation	Budesonide
0115-1689	Budesonide Inhalation	Budesonide
0186-0916	PULMICORT	Budesonide
0186-0917	PULMICORT	Budesonide