FDA.reportPublic FDA data

Cefepime

Product NDC
60505-6145
11-digit product format
605056145
Labeler code
60505
Product ID
60505-6145_12c44be3-e077-4579-ad2e-868b503eadb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefepime
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Apotex Corp.
Application
ANDA203704
Marketing category
ANDA
Marketing start
2017-11-14
Substance
CEFEPIME HYDROCHLORIDE
Active strength
2 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 HYDROCHLORIDE2 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
60505-6145-4Cefepime1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION17
60505-6145-4Cefepime10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-6145-4EA - Each60505-6145b9c583fc-94f1-4030-a709-0f106e4da21212018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-6145CEFEPIME INJECTION, POWDER, FOR SOLUTION [APOTEX CORP.]7Current NDC, Legacy NDC, 2 package rows20230512_d63d360a-15ec-44a4-b80d-b2a5cb5759eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665093cefepime 1 GM InjectionPSNd63d360a-15ec-44a4-b80d-b2a5cb5759eb7
1665088cefepime 2 GM InjectionPSNd63d360a-15ec-44a4-b80d-b2a5cb5759eb7
1665093cefepime 1000 MG InjectionSCDd63d360a-15ec-44a4-b80d-b2a5cb5759eb7
1665088cefepime 2000 MG InjectionSCDd63d360a-15ec-44a4-b80d-b2a5cb5759eb7
1665093cefepime 1 GM (as cefepime HCl) InjectionSYd63d360a-15ec-44a4-b80d-b2a5cb5759eb7
1665088cefepime 2 GM (as cefepime HCl) InjectionSYd63d360a-15ec-44a4-b80d-b2a5cb5759eb7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-6145-46050561450410 VIAL, SINGLE-DOSE in 1 CARTON (60505-6145-4) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE2017-11-140000-00-00NoNoCurrent