FDA.reportPublic FDA data

CEFEPIME

Product NDC
66288-8100
11-digit product format
662888100
Labeler code
66288
Product ID
66288-8100_c3258e86-4c07-4656-9767-ca959ecee86d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEFEPIME
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
SAMSON MEDICAL TECHNOLOGIES LLC
Application
ANDA209408
Marketing category
ANDA
Marketing start
2018-10-01
Substance
CEFEPIME HYDROCHLORIDE
Active strength
100 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 HYDROCHLORIDE100 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI8X1O0607P
Rxcui2058953

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66288-8100-12024-03-12C16284748780-11030e365-5a63-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CEFEPIME FOR INJECTION safely and effectively. See full prescribing information for CEFEPIME FOR INJECTION. CEFEPIME for Injection, for intravenous use PHARMACY BULK PACKAGE - NOT FOR DIRECT INFUSION Initial U.S. Approval: 1996
66288-8100-12024-01-30C16284748780-11030e365-5a63-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CEFEPIME FOR INJECTION safely and effectively. See full prescribing information for CEFEPIME FOR INJECTION. CEFEPIME for Injection, for intravenous use PHARMACY BULK PACKAGE - NOT FOR DIRECT INFUSION Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66288-8100-1CEFEPIME1 in 1 BAGINJECTION, POWDER, FOR SOLUTION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66288-8100-1EA - Each66288-8100b1d05228-89c3-4772-afc3-4944291b5c1412019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66288-8100CEFEPIME INJECTION, POWDER, FOR SOLUTION [SAMSON MEDICAL TECHNOLOGIES LLC]7Current NDC, Legacy NDC, 1 package rows20240314_f776421b-bd46-4664-b9ff-533d805e1277.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2058953cefepime 100 MG/ML Injectable SolutionPSNf776421b-bd46-4664-b9ff-533d805e12777
2058953cefepime 100 MG/ML Injectable SolutionSCDf776421b-bd46-4664-b9ff-533d805e12777

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66288-8100-1662888100011 BAG in 1 BAG (66288-8100-1) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BAG1 bag2018-10-010000-00-00NoNoCurrent