Cefepime

Product NDC
71288-009
11-digit product format
712880009
Labeler code
71288
Product ID
71288-009_9470e6e2-0b42-4796-a5d6-5b09cf469091
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cefepime hydrochloride
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA091048
Marketing category
ANDA
Marketing start
2018-12-17
Marketing end
0000-00-00
Substance
CEFEPIME HYDROCHLORIDE
Active strength
2 g/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71288-009-202024-02-13C16284748780-11030e365-4a82-111a-e063-dadaa90a10e228f1c403-ab91-405e-bf52-ad81b1c66220
71288-009-202024-01-30C16284748780-11030e365-4a82-111a-e063-dadaa90a10e228f1c403-ab91-405e-bf52-ad81b1c66220

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-009-20EA - Each71288-0099852c3e7-8f14-4fb1-827a-063acfbaa87e12019-01-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71288-009-207128800092010 VIAL, SINGLE-DOSE in 1 CARTON (71288-009-20) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-009-21) 2018-12-172023-11-30NoNoCurrent