Vancomycin Hydrochloride

Product NDC
16714-309
11-digit product format
167140309
Labeler code
16714
Product ID
16714-309_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
1 g/20mL
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
16714-309-10EA - Each16714-309c7deb886-0c90-42d8-99cf-a9276c0c1e8012022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-309VANCOMYCIN 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
16714-309-101671403091010 VIAL in 1 CARTON (16714-309-10) > 10 mL in 1 VIAL10 vial2016-03-310000-00-00NoNoCurrent
16714-309-201671403092010 VIAL in 1 CARTON (16714-309-20) > 20 mL in 1 VIAL10 vial2016-03-310000-00-00NoNoCurrent