FDA.reportPublic FDA data

cefepime

Product NDC
25021-121
11-digit product format
250210121
Labeler code
25021
Product ID
25021-121_a980a9e1-16f8-41c8-a8e4-31101948966c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cefepime hydrochloride
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA065441
Marketing category
ANDA
Marketing start
2008-05-01
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
25021-121-20cefepime10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1022
25021-121-20cefepime1 in 1 VIALINJECTION, POWDER, FOR SOLUTION122

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-121-20EA - Each25021-1218261a0bc-1c95-4df0-930e-014279b60b1b12012-07-24
25021-121-66EA - Each25021-121fcbf34f1-218d-4fa4-a5ce-de4705bbe12b12015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
cefepime hydrochlorideACTIVE INGREDIENTI8X1O0607PCEFEPIME (CEFEPIME HYDROCHLORIDE) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]12
cefepimeACTIVE MOIETY807PW4VQE3CEFEPIME (CEFEPIME HYDROCHLORIDE) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]12
arginineINACTIVE INGREDIENT94ZLA3W45FCEFEPIME (CEFEPIME HYDROCHLORIDE) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-121CEFEPIME (CEFEPIME HYDROCHLORIDE) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]22Current NDC, Legacy NDC, 2 package rows20221130_de477f37-40f6-4295-ae72-a2ee36a8922e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665093cefepime 1 GM InjectionPSNde477f37-40f6-4295-ae72-a2ee36a8922e22
1665088cefepime 2 GM InjectionPSNde477f37-40f6-4295-ae72-a2ee36a8922e22
1665093cefepime 1000 MG InjectionSCDde477f37-40f6-4295-ae72-a2ee36a8922e22
1665088cefepime 2000 MG InjectionSCDde477f37-40f6-4295-ae72-a2ee36a8922e22
1665093cefepime 1 GM (as cefepime HCl) InjectionSYde477f37-40f6-4295-ae72-a2ee36a8922e22
1665088cefepime 2 GM (as cefepime HCl) InjectionSYde477f37-40f6-4295-ae72-a2ee36a8922e22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-121-202502101212010 VIAL in 1 CARTON (25021-121-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL10 vial2008-05-010000-00-00NoNoCurrent
25021-121-662502101216610 VIAL in 1 CARTON (25021-121-66) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL10 vial2015-07-010000-00-00NoNoCurrent