Creon

Product NDC
0032-0045
11-digit product format
000320045
Labeler code
0032
Product ID
0032-0045_94463229-9296-4640-854f-41d76386d312
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pancrelipase
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
AbbVie Inc.
Application
BLA020725
Marketing category
BLA
Marketing start
2023-10-12
Substance
PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE
Active strength
15000; 3000; 9500 [USP'U]/1; [USP'U]/1; [USP'U]/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
YOJ58O116EPANCRELIPASE AMYLASE9000-90-2PANCRELIPASE AMYLASE
8MYC33932OPANCRELIPASE LIPASE9001-62-1PANCRELIPASE LIPASE
3560D81V50PANCRELIPASE PROTEASE9001-94-9PANCRELIPASE PROTEASE
FQ3DRG0N5KPANCRELIPASE53608-75-6Pancrelipase

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0032-0045-300003200453070 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0032-0045-30) 2023-10-12YesNoHistorical
0032-0045-700003200457070 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0032-0045-70) 2023-10-12NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
CreonAbbVie Inc.2024-02-28HUMAN PRESCRIPTION DRUG LABEL108