FIRVANQ

Product NDC
65628-016
11-digit product format
656280016
Labeler code
65628
Product ID
65628-016_3858d9dd-2886-4d67-918f-994d8a22fc52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
vancomycin hydrochloride
Dosage form
KIT
Labeler
Azurity Pharmaceuticals, Inc
Application
NDA208910
Marketing category
NDA
Marketing start
2020-02-14
Marketing end
0000-00-00
Active strength
0
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
65628-016-05ML - Milliliter65628-016108fdb5f-9635-4174-8b00-023f6e5b42cf12020-02-13
65628-016-10ML - Milliliter65628-0169b86ce42-150b-41ea-a50b-3665f774afc912020-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65628-016-05656280016051 KIT in 1 CARTON (65628-016-05) * 145 mL in 1 BOTTLE * 15 g in 1 BOTTLE * 289 mL in 1 BOTTLE * 7.5 g in 1 BOTTLE1 kit2020-02-140000-00-00NoNoCurrent
65628-016-10656280016101 KIT in 1 CARTON (65628-016-10) * 145 mL in 1 BOTTLE * 15 g in 1 BOTTLE * 289 mL in 1 BOTTLE * 7.5 g in 1 BOTTLE1 kit2020-02-140000-00-00NoNoCurrent