NDC 0456-0400

Teflaro

Ceftaroline Fosamil

Teflaro is a Intravenous Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Allergan, Inc.. The primary component is Ceftaroline Fosamil.

• Product ID: 0456-0400_0125d943-1b18-45f9-971f-4ee704ec54b7
• NDC: 0456-0400
• Product Type: Human Prescription Drug
• Proprietary Name: Teflaro
• Generic Name: Ceftaroline Fosamil
• Dosage Form: Powder, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2010-10-29
• Marketing Category: NDA / NDA
• Application Number: NDA200327
• Labeler Name: Allergan, Inc.
• Substance Name: CEFTAROLINE FOSAMIL
• Active Ingredient Strength: 400 mg/20mL
• Pharm Classes: Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0456-0400-10

10 VIAL, SINGLE-DOSE in 1 CARTON (0456-0400-10) > 20 mL in 1 VIAL, SINGLE-DOSE (0456-0400-01)

• Marketing Start Date: 2010-10-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0456-0400-01 [00456040001]

Teflaro POWDER, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA200327
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-10-29

NDC 0456-0400-10 [00456040010]

Teflaro POWDER, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA200327
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-10-29

Drug Details

Active Ingredients

Ingredient	Strength
CEFTAROLINE FOSAMIL	400 mg/20mL

OpenFDA Data

• SPL SET ID: 3ecde48b-75a2-4beb-9999-369f3f61bb8a
• Manufacturer:
  • Allergan, Inc.
• UNII:
  • 7P6FQA5D21
• RxNorm Concept Unique ID - RxCUI:
  • 1040014
  • 1040008
  • 1040016
  • 1040012

Pharmacological Class

• Cephalosporin Antibacterial [EPC]
• Cephalosporins [CS]

NDC Crossover Matching brand name "Teflaro" or generic name "Ceftaroline Fosamil"

NDC	Brand Name	Generic Name
0456-0400	Teflaro	ceftaroline fosamil
0456-0600	Teflaro	ceftaroline fosamil