Xipere

Product NDC
71565-040
11-digit product format
715650040
Labeler code
71565
Product ID
71565-040_41a36414-2553-47c7-8a9a-2bed93592e1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
triamcinolone acetonide
Dosage form
INJECTION, SUSPENSION
Route
OPHTHALMIC
Labeler
Clearside Biomedical, Inc.
Application
NDA211950
Marketing category
NDA
Marketing start
2021-11-12
Marketing end
0000-00-00
Substance
TRIAMCINOLONE ACETONIDE
Active strength
40 mg/mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
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
71565-040-01ML - Milliliter71565-040f9404019-e362-42b2-b875-7e5e4fbd05e512021-12-08
71565-040-25ML - Milliliter71565-040e299154f-5ac6-4cd9-b099-a477e9a61c7f12021-12-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71565-040-01715650040011 TRAY in 1 CARTON (71565-040-01) > 1 VIAL in 1 TRAY > .9 mL in 1 VIAL (71565-040-25) 1 tray2021-11-120000-00-00NoNoCurrent
71565-040-99715650040991 TRAY in 1 CARTON (71565-040-99) > 1 VIAL in 1 TRAY > .9 mL in 1 VIAL (71565-040-95) 1 tray2021-11-120000-00-00YesNoCurrent