FDA.reportPublic FDA data

Cefepime

Product NDC
0338-1301
11-digit product format
003381301
Labeler code
0338
Product ID
0338-1301_7e2eb55e-e6d6-40a0-9274-274fff3d9262
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cefepime
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Company
Application
NDA050817
Marketing category
NDA
Marketing start
2008-08-05
Substance
CEFEPIME HYDROCHLORIDE
Active strength
1 g/50mL
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cefepime
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFEPIME HYDROCHLORIDE1 g/50mL

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
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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
0338-1301-41Cefepime50 mL in 1 BAGINJECTION, SOLUTION5028
0338-1301-41Cefepime24 in 1 BOXINJECTION, SOLUTION2428
0338-1301-48Cefepime100 mL in 1 BAGINJECTION, SOLUTION10028
0338-1301-48Cefepime12 in 1 BOXINJECTION, SOLUTION1228

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-1301-41ML - Milliliter0338-130126a9cbf0-f849-47e0-a90c-88af8d7a2cb612012-07-24
0338-1301-48ML - Milliliter0338-130125a52550-9eca-4f57-8f43-b9d0fe9988ca12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFEPIME HYDROCHLORIDEACTIVE INGREDIENTI8X1O0607PCEFEPIME INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]10
CEFEPIMEACTIVE MOIETY807PW4VQE3CEFEPIME INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]10
ARGININEINACTIVE INGREDIENT94ZLA3W45FCEFEPIME INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]10
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083GCEFEPIME INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]10
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBCEFEPIME INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]10
WATERINACTIVE INGREDIENT059QF0KO0RCEFEPIME INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-1301CEFEPIME INJECTION, SOLUTION [BAXTER HEALTHCARE COMPANY]25Current NDC, Legacy NDC, 4 package rows20250410_be5f8ca6-7232-423a-a2d5-cccb7abe7921.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665093cefepime 1 GM InjectionPSNbe5f8ca6-7232-423a-a2d5-cccb7abe792128
1665088cefepime 2 GM InjectionPSNbe5f8ca6-7232-423a-a2d5-cccb7abe792128
1665093cefepime 1000 MG InjectionSCDbe5f8ca6-7232-423a-a2d5-cccb7abe792128
1665088cefepime 2000 MG InjectionSCDbe5f8ca6-7232-423a-a2d5-cccb7abe792128
1665093cefepime 1 GM (as cefepime HCl) InjectionSYbe5f8ca6-7232-423a-a2d5-cccb7abe792128
1665088cefepime 2 GM (as cefepime HCl) InjectionSYbe5f8ca6-7232-423a-a2d5-cccb7abe792128

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-1301-410033813014124 BAG in 1 BOX (0338-1301-41) / 50 mL in 1 BAG24 bag2008-08-050000-00-00NoNoCurrent
0338-1301-480033813014812 BAG in 1 BOX (0338-1301-48) / 100 mL in 1 BAG12 bag2008-08-050000-00-00NoNoCurrent