"58914-005-50" National Drug Code (NDC)

Ultresa 1 BOTTLE in 1 CARTON (58914-005-50) > 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE
(Aptalis Pharma US, Inc)

NDC Code58914-005-50
Package Description1 BOTTLE in 1 CARTON (58914-005-50) > 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Product NDC58914-005
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameUltresa
Non-Proprietary NamePancrelipase
Dosage FormCAPSULE, DELAYED RELEASE
UsageORAL
Start Marketing Date20120301
Marketing Category NameNDA
Application NumberNDA022222
ManufacturerAptalis Pharma US, Inc
Substance NamePANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE
Strength46000; 23000; 46000
Strength Unit[USP'U]/1; [USP'U]/1; [USP'U]/1

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