NDC 50090-1403

SYMBICORT

Budesonide And Formoterol Fumarate Dihydrate

SYMBICORT is a Respiratory (inhalation) Aerosol in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Budesonide; Formoterol Fumarate.

• Product ID: 50090-1403_bda9d789-4d3d-4d02-9fbb-ef55a585b5bd
• NDC: 50090-1403
• Product Type: Human Prescription Drug
• Proprietary Name: SYMBICORT
• Generic Name: Budesonide And Formoterol Fumarate Dihydrate
• Dosage Form: Aerosol
• Route of Administration: RESPIRATORY (INHALATION)
• Marketing Start Date: 2007-05-29
• Marketing Category: NDA / NDA
• Application Number: NDA021929
• Labeler Name: A-S Medication Solutions
• Substance Name: BUDESONIDE; FORMOTEROL FUMARATE
• Active Ingredient Strength: 160 ug/1; ug/1
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 50090-1403-0

1 POUCH in 1 CARTON (50090-1403-0) > 1 AEROSOL in 1 POUCH

• Marketing Start Date: 2014-11-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50090-1403-0 [50090140300]

SYMBICORT AEROSOL

• Marketing Category: NDA
• Application Number: NDA021929
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2014-11-28
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
BUDESONIDE	160 ug/1

OpenFDA Data

• SPL SET ID: 6b78d08a-e098-4188-8f7f-94fbd5f396ef
• Manufacturer:
  • A-S Medication Solutions
• UNII:
  • W34SHF8J2K
  • Q3OKS62Q6X

Pharmacological Class

• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]
• Adrenergic beta2-Agonists [MoA]
• beta2-Adrenergic Agonist [EPC]

NDC Crossover Matching brand name "SYMBICORT" or generic name "Budesonide And Formoterol Fumarate Dihydrate"

NDC	Brand Name	Generic Name
0186-0370	SYMBICORT	Budesonide and Formoterol Fumarate Dihydrate
0186-0372	SYMBICORT	Budesonide and Formoterol Fumarate Dihydrate
50090-1403	SYMBICORT	Budesonide and Formoterol Fumarate Dihydrate
70518-2696	SYMBICORT	Budesonide and Formoterol Fumarate Dihydrate
0310-7370	Budesonide and Formoterol Fumarate Dihydrate	Budesonide and Formoterol Fumarate Dihydrate
0310-7372	Budesonide and Formoterol Fumarate Dihydrate	Budesonide and Formoterol Fumarate Dihydrate
53002-2666	Budesonide and Formoterol Fumarate Dihydrate	Budesonide and Formoterol Fumarate Dihydrate
53002-2667	Budesonide and Formoterol Fumarate Dihydrate	Budesonide and Formoterol Fumarate Dihydrate
70518-3107	Budesonide and Formoterol Fumarate Dihydrate	Budesonide and Formoterol Fumarate Dihydrate