Vancomycin Hydrochloride

Product NDC
16714-247
11-digit product format
167140247
Labeler code
16714
Product ID
16714-247_35e6482a-e807-4504-a06c-adbcfb2e3e4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vancomycin Hydrochloride
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
NorthStar Rx LLC
Application
ANDA205780
Marketing category
ANDA
Marketing start
2016-03-31
Marketing end
0000-00-00
Substance
VANCOMYCIN HYDROCHLORIDE
Active strength
500 mg/10mL
Pharmacologic classes
Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-247-10EA - Each16714-2471938e53e-2f34-428c-bcbc-9714490b074912022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-247VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NORTHSTAR RX LLC]3Legacy NDC20231208_aa4be6d1-ef15-4d44-82a8-dc6291c95f30.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-247-101671402471010 VIAL in 1 CARTON (16714-247-10) > 10 mL in 1 VIAL10 vial2016-03-310000-00-00NoNoCurrent