FDA.reportPublic FDA data

CEFEPIME HYDROCHLORIDE AND DEXTROSE

Product NDC
0264-3193
11-digit product format
002643193
Labeler code
0264
Product ID
0264-3193_8b4b5fb9-6be2-40c8-a8ef-60a9d7967e3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEFEPIME HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
B. Braun Medical Inc.
Application
NDA050821
Marketing category
NDA
Marketing start
2010-05-06
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 HYDROCHLORIDE AND DEXTROSE
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
61f3932f-d389-4aed-124d-cf14f88e190fProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0264-3193-11CEFEPIME HYDROCHLORIDE AND DEXTROSE50 mL in 1 CONTAINERINJECTION, SOLUTION5025
0264-3193-11CEFEPIME HYDROCHLORIDE AND DEXTROSE24 in 1 CASEINJECTION, SOLUTION2425

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0264-3193-11EA - Each0264-31936309c1d6-cf77-4474-a7b7-143c9034c24e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFEPIME HYDROCHLORIDEACTIVE INGREDIENTI8X1O0607PCEFEPIME HYDROCHLORIDE AND DEXTROSE (CEFEPIME HYDROCHLORIDE) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]18
CEFEPIMEACTIVE MOIETY807PW4VQE3CEFEPIME HYDROCHLORIDE AND DEXTROSE (CEFEPIME HYDROCHLORIDE) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]18
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083GCEFEPIME HYDROCHLORIDE AND DEXTROSE (CEFEPIME HYDROCHLORIDE) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]18
WATERINACTIVE INGREDIENT059QF0KO0RCEFEPIME HYDROCHLORIDE AND DEXTROSE (CEFEPIME HYDROCHLORIDE) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0264-3193CEFEPIME HYDROCHLORIDE AND DEXTROSE (CEFEPIME HYDROCHLORIDE) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]23Current NDC, Legacy NDC, 2 package rows20220402_57517a0e-ec1b-4605-a7cc-7e3801158ec9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665093cefepime 1 GM InjectionPSN57517a0e-ec1b-4605-a7cc-7e3801158ec925
1665088cefepime 2 GM InjectionPSN57517a0e-ec1b-4605-a7cc-7e3801158ec925
1665093cefepime 1000 MG InjectionSCD57517a0e-ec1b-4605-a7cc-7e3801158ec925
1665088cefepime 2000 MG InjectionSCD57517a0e-ec1b-4605-a7cc-7e3801158ec925
1665093cefepime 1 GM (as cefepime HCl) InjectionSY57517a0e-ec1b-4605-a7cc-7e3801158ec925
1665088cefepime 2 GM (as cefepime HCl) InjectionSY57517a0e-ec1b-4605-a7cc-7e3801158ec925

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0264-3193-110026431931124 CONTAINER in 1 CASE (0264-3193-11) / 50 mL in 1 CONTAINER24 container2010-05-060000-00-00NoNoCurrent