NDC 21695-291

PULMICORT FLEXHALER

Budesonide

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

• Product ID: 21695-291_0950cd08-a48b-4376-9647-da22cf5a8a70
• NDC: 21695-291
• Product Type: Human Prescription Drug
• Proprietary Name: PULMICORT FLEXHALER
• Generic Name: Budesonide
• Dosage Form: Aerosol, Powder
• Route of Administration: RESPIRATORY (INHALATION)
• Marketing Start Date: 2010-07-30
• Marketing Category: NDA / NDA
• Application Number: NDA021949
• Labeler Name: Rebel Distributors Corp
• Substance Name: BUDESONIDE
• Active Ingredient Strength: 90 ug/1
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 21695-291-01

1 INHALER in 1 CARTON (21695-291-01) > 60 AEROSOL, POWDER in 1 INHALER

• Marketing Start Date: 2010-07-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 21695-291-01 [21695029101]

PULMICORT FLEXHALER AEROSOL, POWDER

• Marketing Category: NDA
• Application Number: NDA021949
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-07-30
• Inactivation Date: 2019-09-24

Drug Details

Active Ingredients

Ingredient	Strength
BUDESONIDE	90 ug/1

OpenFDA Data

• SPL SET ID: 0950cd08-a48b-4376-9647-da22cf5a8a70
• Manufacturer:
  • Rebel Distributors Corp
• UNII:
  • Q3OKS62Q6X
• RxNorm Concept Unique ID - RxCUI:
  • 966527
  • 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