FDA.reportPublic FDA data

Cefepime

Product NDC
44567-241
11-digit product format
445670241
Labeler code
44567
Product ID
44567-241_9202aa9e-9a7a-46a7-b964-72330948ed4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefepime
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
WG Critical Care, LLC
Application
ANDA065441
Marketing category
ANDA
Marketing start
2014-10-10
Substance
CEFEPIME HYDROCHLORIDE
Active strength
2 g/20mL
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cefepime
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFEPIME HYDROCHLORIDE2 g/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI8X1O0607P
Rxcui1665088, 1665093

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4878f213-798f-d240-b895-da945519fdacProduct name520250221
2c48ebbc-4556-4270-89c4-74bed6fedfeaProduct name120250117
c050dd27-f8ee-4d60-beb5-08930938e02eProduct name120231115
61f3932f-d389-4aed-124d-cf14f88e190fProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44567-241-10Cefepime10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1015
44567-241-10Cefepime20 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION2015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44567-241-10EA - Each44567-241b1f40203-e663-4a05-8871-9196cb3f783912013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFEPIME HYDROCHLORIDEACTIVE INGREDIENTI8X1O0607PCEFEPIME INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]3
CEFEPIMEACTIVE MOIETY807PW4VQE3CEFEPIME INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44567-241CEFEPIME INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]13Current NDC, Legacy NDC, 2 package rows20240228_5fd857e5-591f-44ca-80cf-fd903660b03c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665093cefepime 1 GM InjectionPSN5fd857e5-591f-44ca-80cf-fd903660b03c15
1665088cefepime 2 GM InjectionPSN5fd857e5-591f-44ca-80cf-fd903660b03c15
1665093cefepime 1000 MG InjectionSCD5fd857e5-591f-44ca-80cf-fd903660b03c15
1665088cefepime 2000 MG InjectionSCD5fd857e5-591f-44ca-80cf-fd903660b03c15
1665093cefepime 1 GM (as cefepime HCl) InjectionSY5fd857e5-591f-44ca-80cf-fd903660b03c15
1665088cefepime 2 GM (as cefepime HCl) InjectionSY5fd857e5-591f-44ca-80cf-fd903660b03c15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44567-241-104456702411010 VIAL in 1 CARTON (44567-241-10) / 20 mL in 1 VIAL10 vial2014-10-100000-00-00NoNoCurrent