FDA.reportPublic FDA data

Cefepime

Product NDC
63323-326
11-digit product format
633230326
Labeler code
63323
Product ID
63323-326_8c2fbf43-34bd-49d1-bda8-a2191c8bc54b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefepime
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA065441
Marketing category
ANDA
Marketing start
2010-08-30
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
63323-326-20Cefepime10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1011
63323-326-21Cefepime1 in 1 VIALINJECTION, POWDER, FOR SOLUTION111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-326-20EA - Each63323-3266223e7cb-e669-4170-b11e-4869e3767bed12012-07-24
63323-326-21EA - Each63323-326d2bc8562-433a-4132-b056-14a9fd0a8d0b12018-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFEPIME HYDROCHLORIDEACTIVE INGREDIENTI8X1O0607PCEFEPIME INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]5
CEFEPIMEACTIVE MOIETY807PW4VQE3CEFEPIME INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-326CEFEPIME INJECTION, POWDER, FOR SOLUTION CEFEPIME (CEFEPIME) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]11Current NDC, Legacy NDC, 2 package rows20231014_5e1695e0-1310-4cd8-a5da-ad1a7dcd1792.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665093cefepime 1 GM InjectionPSN5e1695e0-1310-4cd8-a5da-ad1a7dcd179211
1665088cefepime 2 GM InjectionPSN5e1695e0-1310-4cd8-a5da-ad1a7dcd179211
1665093cefepime 1000 MG InjectionSCD5e1695e0-1310-4cd8-a5da-ad1a7dcd179211
1665088cefepime 2000 MG InjectionSCD5e1695e0-1310-4cd8-a5da-ad1a7dcd179211
1665093cefepime 1 GM (as cefepime HCl) InjectionSY5e1695e0-1310-4cd8-a5da-ad1a7dcd179211
1665088cefepime 2 GM (as cefepime HCl) InjectionSY5e1695e0-1310-4cd8-a5da-ad1a7dcd179211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-326-206332303262010 VIAL in 1 CARTON (63323-326-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (63323-326-21) 10 vial2010-08-300000-00-00NoNoCurrent
63323-326-21633230326211 in 1 VIALHistorical