Cefepime

Product NDC
71288-008
11-digit product format
712880008
Labeler code
71288
Product ID
71288-008_9470e6e2-0b42-4796-a5d6-5b09cf469091
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cefepime hydrochloride
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; 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
1 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
71288-008-152024-02-13C16284748780-11030e365-4a82-111a-e063-dadaa90a10e228f1c403-ab91-405e-bf52-ad81b1c66220
71288-008-152024-01-30C16284748780-11030e365-4a82-111a-e063-dadaa90a10e228f1c403-ab91-405e-bf52-ad81b1c66220

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-008-15EA - Each71288-00865a9a2c9-ece5-4b89-9760-6f85bec8b15512019-01-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71288-008-157128800081510 VIAL, SINGLE-DOSE in 1 CARTON (71288-008-15) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-008-16) 2018-12-170000-00-00NoNoCurrent