Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Physicians Total Care, Inc.
Physicians Total Care, Inc.
194123980
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ZENPEP
Product Details
NDC Product Code
54868-6435Application Number
NDA022210Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
September 15, 2014Pancrelipase proteaseActive
Code: 3560D81V50Class: ACTIBQuantity: 34000 [USP'U] in 1 1
Pancrelipase lipaseActive
Code: 8MYC33932OClass: ACTIBQuantity: 10000 [USP'U] in 1 1
Pancrelipase amylaseActive
Code: YOJ58O116EClass: ACTIBQuantity: 55000 [USP'U] in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEYClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)Inactive
Code: 8LDD2V82F5Class: IACT
CARRAGEENANInactive
Code: 5C69YCD2YJClass: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT