NDC 0186-0916

PULMICORT FLEXHALER

Budesonide

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

• Product ID: 0186-0916_0cf571de-53d5-4c3d-89a6-abf4d6ce52db
• NDC: 0186-0916
• Product Type: Human Prescription Drug
• Proprietary Name: PULMICORT FLEXHALER
• Generic Name: Budesonide
• Dosage Form: Aerosol, Powder
• Route of Administration: RESPIRATORY (INHALATION)
• Marketing Start Date: 2007-03-19
• Marketing Category: NDA / NDA
• Application Number: NDA021949
• Labeler Name: AstraZeneca Pharmaceuticals LP
• Substance Name: BUDESONIDE
• Active Ingredient Strength: 180 ug/1
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0186-0916-12

1 INHALER in 1 CARTON (0186-0916-12) > 120 AEROSOL, POWDER in 1 INHALER

• Marketing Start Date: 2007-03-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0186-0916-65 [00186091665]

PULMICORT FLEXHALER AEROSOL, POWDER

• Marketing Category: NDA
• Application Number: NDA021949
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2007-03-19
• Marketing End Date: 2019-09-19

NDC 0186-0916-12 [00186091612]

PULMICORT FLEXHALER AEROSOL, POWDER

• Marketing Category: NDA
• Application Number: NDA021949
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2007-03-19

Drug Details

Active Ingredients

Ingredient	Strength
BUDESONIDE	180 ug/1

OpenFDA Data

• SPL SET ID: 54234b7d-3bcc-4809-1881-1d21484856a0
• Manufacturer:
  • AstraZeneca Pharmaceuticals LP
• UNII:
  • Q3OKS62Q6X
• RxNorm Concept Unique ID - RxCUI:
  • 966527
  • 966524
  • 966522
  • 966529

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
21695-291	PULMICORT FLEXHALER	PULMICORT FLEXHALER
50090-2239	PULMICORT FLEXHALER	PULMICORT FLEXHALER
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
0186-1988	PULMICORT RESPULES	Budesonide
0186-1989	PULMICORT RESPULES	Budesonide
0186-1990	PULMICORT RESPULES	Budesonide