teflaro

Generic: ceftaroline fosamil

Labeler: allergan, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name teflaro
Generic Name ceftaroline fosamil
Labeler allergan, inc.
Dosage Form POWDER, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

ceftaroline fosamil 400 mg/20mL

Manufacturer
Allergan, Inc.

Identifiers & Regulatory

Product NDC 0456-0400
Product ID 0456-0400_80f8b668-c4e3-472a-acfa-edececd8b7e4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA200327
Listing Expiration 2026-12-31
Marketing Start 2010-10-29

Pharmacologic Class

Classes
cephalosporin antibacterial [epc] cephalosporins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04560400
Hyphenated Format 0456-0400

Supplemental Identifiers

RxCUI
1040008 1040012 1040014 1040016
UPC
0304560400103
UNII
7P6FQA5D21

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name teflaro (source: ndc)
Generic Name ceftaroline fosamil (source: ndc)
Application Number NDA200327 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 400 mg/20mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (0456-0400-10) / 20 mL in 1 VIAL, SINGLE-DOSE (0456-0400-01)
source: ndc

Packages (1)

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

Ingredients (1)

ceftaroline fosamil (400 mg/20mL)

Linked Drug Pages (1)

Teflaro ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "80f8b668-c4e3-472a-acfa-edececd8b7e4", "openfda": {"upc": ["0304560400103"], "unii": ["7P6FQA5D21"], "rxcui": ["1040008", "1040012", "1040014", "1040016"], "spl_set_id": ["3ecde48b-75a2-4beb-9999-369f3f61bb8a"], "manufacturer_name": ["Allergan, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (0456-0400-10)  / 20 mL in 1 VIAL, SINGLE-DOSE (0456-0400-01)", "package_ndc": "0456-0400-10", "marketing_start_date": "20101029"}], "brand_name": "Teflaro", "product_id": "0456-0400_80f8b668-c4e3-472a-acfa-edececd8b7e4", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "0456-0400", "generic_name": "ceftaroline fosamil", "labeler_name": "Allergan, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Teflaro", "active_ingredients": [{"name": "CEFTAROLINE FOSAMIL", "strength": "400 mg/20mL"}], "application_number": "NDA200327", "marketing_category": "NDA", "marketing_start_date": "20101029", "listing_expiration_date": "20261231"}