FDA.reportPublic FDA data

Cefepime

Product NDC
0409-9566
11-digit product format
004099566
Labeler code
0409
Product ID
0409-9566_ab7654ec-e6eb-499c-9aab-63d9b76394a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefepime
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA065441
Marketing category
ANDA
Marketing start
2020-08-24
Substance
CEFEPIME HYDROCHLORIDE
Active strength
1 g/1
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
Cefepime
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFEPIME HYDROCHLORIDE1 g/1

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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
61f3932f-d389-4aed-124d-cf14f88e190fProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-9566-01Cefepime1 in 1 VIALINJECTION, POWDER, FOR SOLUTION14
0409-9566-10Cefepime10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-9566-01EA - Each0409-956632b52a99-1192-493d-9793-56a52857ecd912020-09-14
0409-9566-10EA - Each0409-956675339c82-56a0-4d0b-98d1-7db71e337cd412020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-9566CEFEPIME INJECTION, POWDER, FOR SOLUTION [HOSPIRA, INC.]4Current NDC, Legacy NDC, 2 package rows20241108_e80c27e2-164d-4836-ba24-c160d75dc5d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665093cefepime 1 GM InjectionPSNe80c27e2-164d-4836-ba24-c160d75dc5d34
1665088cefepime 2 GM InjectionPSNe80c27e2-164d-4836-ba24-c160d75dc5d34
1665093cefepime 1000 MG InjectionSCDe80c27e2-164d-4836-ba24-c160d75dc5d34
1665088cefepime 2000 MG InjectionSCDe80c27e2-164d-4836-ba24-c160d75dc5d34
1665093cefepime 1 GM (as cefepime HCl) InjectionSYe80c27e2-164d-4836-ba24-c160d75dc5d34
1665088cefepime 2 GM (as cefepime HCl) InjectionSYe80c27e2-164d-4836-ba24-c160d75dc5d34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-9566-01004099566011 in 1 VIALHistorical
0409-9566-100040995661010 VIAL in 1 CARTON (0409-9566-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-9566-01) 10 vial2020-08-240000-00-00NoNoCurrent