NDC 0186-0370

SYMBICORT

Budesonide And Formoterol Fumarate Dihydrate

SYMBICORT is a Respiratory (inhalation) Aerosol in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Budesonide; Formoterol Fumarate.

• Product ID: 0186-0370_5b03fd09-2533-4975-88da-a0b9c8495d1e
• NDC: 0186-0370
• 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: AstraZeneca Pharmaceuticals LP
• 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: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0186-0370-20

1 POUCH in 1 CARTON (0186-0370-20) > 1 CANISTER in 1 POUCH > 120 AEROSOL in 1 CANISTER

• Marketing Start Date: 2007-05-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0186-0370-28 [00186037028]

SYMBICORT AEROSOL

• Marketing Category: NDA
• Application Number: NDA021929
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2007-09-06

NDC 0186-0370-20 [00186037020]

SYMBICORT AEROSOL

• Marketing Category: NDA
• Application Number: NDA021929
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2007-05-29

NDC 0186-0370-60 [00186037060]

SYMBICORT AEROSOL

• Marketing Category: NDA
• Application Number: NDA021929
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2007-09-06

Drug Details

Active Ingredients

Ingredient	Strength
BUDESONIDE	160 ug/1

OpenFDA Data

• SPL SET ID: fafa4cf1-99c2-43d5-73ad-51f256de3be0
• Manufacturer:
  • AstraZeneca Pharmaceuticals LP
• UNII:
  • W34SHF8J2K
  • Q3OKS62Q6X
• RxNorm Concept Unique ID - RxCUI:
  • 1246290
  • 1246288
  • 1246304
  • 1246306
  • 1246316
  • 1246317
  • 1246314
  • 1246315

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