Cefepime

Product NDC
67184-1004
11-digit product format
671841004
Labeler code
67184
Product ID
67184-1004_34afba66-733f-4403-83d1-1b67b8a6633b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEFEPIME HYDROCHLORIDE
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Qilu Pharmaceutical Co., Ltd.
Application
ANDA203704
Marketing category
ANDA
Marketing start
2016-02-01
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, 1665097

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
67184-1004-1Cefepime10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION104
67184-1004-1Cefepime1 in 1 VIALINJECTION, POWDER, FOR SOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67184-1004CEFEPIME (CEFEPIME HYDROCHLORIDE) INJECTION, POWDER, FOR SOLUTION [QILU PHARMACEUTICAL CO., LTD.]4Current NDC, Legacy NDC, 2 package rows20211115_80b4c811-4a71-47fb-8565-85ce9d0f782c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665093cefepime 1 GM InjectionPSN80b4c811-4a71-47fb-8565-85ce9d0f782c4
1665088cefepime 2 GM InjectionPSN80b4c811-4a71-47fb-8565-85ce9d0f782c4
1665097cefepime 500 MG InjectionPSN80b4c811-4a71-47fb-8565-85ce9d0f782c4
1665093cefepime 1000 MG InjectionSCD80b4c811-4a71-47fb-8565-85ce9d0f782c4
1665088cefepime 2000 MG InjectionSCD80b4c811-4a71-47fb-8565-85ce9d0f782c4
1665097cefepime 500 MG InjectionSCD80b4c811-4a71-47fb-8565-85ce9d0f782c4
1665093cefepime 1 GM (as cefepime HCl) InjectionSY80b4c811-4a71-47fb-8565-85ce9d0f782c4
1665088cefepime 2 GM (as cefepime HCl) InjectionSY80b4c811-4a71-47fb-8565-85ce9d0f782c4
1665097cefepime 500 MG (as cefepime HCl) InjectionSY80b4c811-4a71-47fb-8565-85ce9d0f782c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67184-1004-16718410040110 VIAL in 1 CARTON (67184-1004-1) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL10 vial2016-02-010000-00-00NoNoCurrent