FDA.reportPublic FDA data

Cefepime

Product NDC
44567-130
11-digit product format
445670130
Labeler code
44567
Product ID
44567-130_5a8ec08f-ddc8-4ce9-9ef4-4d97a9188f9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefepime
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
WG Critical Care, LLC
Application
ANDA065441
Marketing category
ANDA
Marketing start
2021-03-31
Substance
CEFEPIME HYDROCHLORIDE
Active strength
1 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 HYDROCHLORIDE1 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
44567-130-10Cefepime10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION107
44567-130-10Cefepime20 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION207

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44567-130-10EA - Each44567-1302842f83a-0a0f-4d3f-8d94-450c21c8038e12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44567-130CEFEPIME INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]4Current NDC, Legacy NDC, 2 package rows20231103_c654ef2e-1067-4026-8931-6a0dc2a17ad1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665093cefepime 1 GM InjectionPSNc654ef2e-1067-4026-8931-6a0dc2a17ad17
1665088cefepime 2 GM InjectionPSNc654ef2e-1067-4026-8931-6a0dc2a17ad17
1665093cefepime 1000 MG InjectionSCDc654ef2e-1067-4026-8931-6a0dc2a17ad17
1665088cefepime 2000 MG InjectionSCDc654ef2e-1067-4026-8931-6a0dc2a17ad17
1665093cefepime 1 GM (as cefepime HCl) InjectionSYc654ef2e-1067-4026-8931-6a0dc2a17ad17
1665088cefepime 2 GM (as cefepime HCl) InjectionSYc654ef2e-1067-4026-8931-6a0dc2a17ad17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44567-130-104456701301010 VIAL in 1 CARTON (44567-130-10) / 20 mL in 1 VIAL10 vial2021-03-310000-00-00NoNoCurrent