Cefepime

Product NDC
71288-021
11-digit product format
712880021
Labeler code
71288
Product ID
71288-021_29116a89-8b37-4fd0-b0b8-5f42d3e63228
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cefepime hydrochloride
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA212721
Marketing category
ANDA
Marketing start
2020-07-21
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
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71288-021-212024-02-13C16284748780-1f386c64a-20c3-0266-e053-dadaa90a7c1afafc9cde-18fd-46ed-b50d-4586ed40c5fc
71288-021-212023-01-30C16284748780-1f386c64a-20c3-0266-e053-dadaa90a7c1afafc9cde-18fd-46ed-b50d-4586ed40c5fc

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71288-021-217128800212110 VIAL, SINGLE-DOSE in 1 CARTON (71288-021-21) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-021-20) 2020-07-210000-00-00NoNoCurrent