Vancomycin Hydrochloride

Product NDC
47781-597
11-digit product format
477810597
Labeler code
47781
Product ID
47781-597_477dcb18-55f4-dc92-fe3b-5fb483fe6c5e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
vancomycin hydrochloride
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Alvogen Inc.
Application
ANDA205694
Marketing category
ANDA
Marketing start
2017-08-28
Marketing end
2022-04-01
Substance
VANCOMYCIN HYDROCHLORIDE
Active strength
1 g/20mL
Pharmacologic classes
Glycopeptide Antibacterial [EPC],Glycopeptides [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-597-07EA - Each47781-597d91239e5-d403-451b-999d-ab9f30fed05b12018-03-08
47781-597-91EA - Each47781-5977b1b49a0-2bd8-4f60-9696-4402b196955412017-09-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47781-597-914778105979110 VIAL in 1 CARTON (47781-597-91) > 20 mL in 1 VIAL (47781-597-07) 10 vial2017-08-282022-04-01NoNoCurrent