CEFEPIME HYDROCHLORIDE

Product NDC
70594-090
11-digit product format
705940090
Labeler code
70594
Product ID
70594-090_5ceacb56-4bff-4036-aadd-2843c6fe45cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEFEPIME HYDROCHLORIDE
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Xellia Pharmaceuticals USA LLC
Application
ANDA212721
Marketing category
ANDA
Marketing start
2021-01-10
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#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70594-090-01EA - Each70594-090433a91b4-57ce-4c51-a8a5-8410b56cd02312021-12-08
70594-090-02EA - Each70594-0903592fccd-4c45-4fa4-83b3-45c4763d183c12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70594-090CEFEPIME HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC]4Legacy NDC20241213_91f72dcf-eb1f-4fc6-b9a2-042424012e3e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70594-090-027059400900210 VIAL in 1 CARTON (70594-090-02) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-090-01) 10 vial2021-01-100000-00-00NoNoCurrent