Fentanyl Citrate

Product NDC
63323-817
11-digit product format
633230817
Labeler code
63323
Product ID
63323-817_8fca5c17-40f0-4b06-8beb-fd2f49229f7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fentanyl Citrate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA212086
Marketing category
ANDA
Marketing start
2021-01-15
Marketing end
0000-00-00
Substance
FENTANYL CITRATE
Active strength
100 ug/2mL
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-817-01ML - Milliliter63323-817aa67546e-16b8-4297-a649-655cf3ea1eb012021-10-08
63323-817-20ML - Milliliter63323-817b58924d1-9e57-4bd0-bfa8-c25c04b2478212021-10-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-817-206332308172010 SYRINGE in 1 CARTON (63323-817-20) > 2 mL in 1 SYRINGE (63323-817-01) 10 syringe2021-01-150000-00-00NoNoCurrent