FDA.reportPublic FDA data

Teflaro

Product NDC
0456-0400
11-digit product format
004560400
Labeler code
0456
Product ID
0456-0400_80f8b668-c4e3-472a-acfa-edececd8b7e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ceftaroline fosamil
Dosage form
POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Allergan, Inc.
Application
NDA200327
Marketing category
NDA
Marketing start
2010-10-29
Substance
CEFTAROLINE FOSAMIL
Active strength
400 mg/20mL
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Teflaro
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFTAROLINE FOSAMIL400 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7P6FQA5D21
Rxcui1040008, 1040012, 1040014, 1040016

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5748b1db-3b49-460c-ad6d-f428c51d042bProduct name220220316
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0456-0400-01Teflaro20 mL in 1 VIAL, SINGLE-DOSEPOWDER, FOR SOLUTION2043
0456-0400-10Teflaro10 in 1 CARTONPOWDER, FOR SOLUTION1043

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0456-0400-01EA - Each0456-04000fc22a77-53fe-479d-a843-4b3594ae298e12012-07-24
0456-0400-10EA - Each0456-04004269549a-ecba-433f-ad50-2b2ce16c98cc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFTAROLINE FOSAMILACTIVE INGREDIENT7P6FQA5D21TEFLARO (CEFTAROLINE FOSAMIL) POWDER, FOR SOLUTION [FOREST LABORATORIES, INC. ]17
CEFTAROLINEACTIVE MOIETYH36Z0FHR8KTEFLARO (CEFTAROLINE FOSAMIL) POWDER, FOR SOLUTION [FOREST LABORATORIES, INC. ]17
ARGININEINACTIVE INGREDIENT94ZLA3W45FTEFLARO (CEFTAROLINE FOSAMIL) POWDER, FOR SOLUTION [FOREST LABORATORIES, INC. ]17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0456-0400TEFLARO (CEFTAROLINE FOSAMIL) POWDER, FOR SOLUTION [ALLERGAN, INC.]42Current NDC, Legacy NDC, 2 package rows20241127_3ecde48b-75a2-4beb-9999-369f3f61bb8a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1040008ceftaroline fosamil 400 MG InjectionPSN3ecde48b-75a2-4beb-9999-369f3f61bb8a43
1040014ceftaroline fosamil 600 MG InjectionPSN3ecde48b-75a2-4beb-9999-369f3f61bb8a43
1040012Teflaro 400 MG InjectionPSN3ecde48b-75a2-4beb-9999-369f3f61bb8a43
1040016Teflaro 600 MG InjectionPSN3ecde48b-75a2-4beb-9999-369f3f61bb8a43
1040012ceftaroline fosamil 400 MG Injection [Teflaro]SBD3ecde48b-75a2-4beb-9999-369f3f61bb8a43
1040016ceftaroline fosamil 600 MG Injection [Teflaro]SBD3ecde48b-75a2-4beb-9999-369f3f61bb8a43
1040008ceftaroline fosamil 400 MG InjectionSCD3ecde48b-75a2-4beb-9999-369f3f61bb8a43
1040014ceftaroline fosamil 600 MG InjectionSCD3ecde48b-75a2-4beb-9999-369f3f61bb8a43
1040012Teflaro 400 MG InjectionSY3ecde48b-75a2-4beb-9999-369f3f61bb8a43
1040016Teflaro 600 MG InjectionSY3ecde48b-75a2-4beb-9999-369f3f61bb8a43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0456-0400-010045604000120 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical
0456-0400-100045604001010 VIAL, SINGLE-DOSE in 1 CARTON (0456-0400-10) / 20 mL in 1 VIAL, SINGLE-DOSE (0456-0400-01) 2010-10-290000-00-00NoNoCurrent