Product NDC: | 54868-6067 |
Proprietary Name: | Creon |
Non Proprietary Name: | Pancrelipase |
Active Ingredient(s): | 60000; 12000; 38000 [USP'U]/1; [USP'U]/1; [USP'U]/1 & nbsp; Pancrelipase |
Administration Route(s): | ORAL |
Dosage Form(s): | CAPSULE, DELAYED RELEASE PELLETS |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 54868-6067 |
Labeler Name: | Physicians Total Care, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA020725 |
Marketing Category: | NDA |
Start Marketing Date: | 20090929 |
Package NDC: | 54868-6067-1 |
Package Description: | 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (54868-6067-1) |
NDC Code | 54868-6067-1 |
Proprietary Name | Creon |
Package Description | 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (54868-6067-1) |
Product NDC | 54868-6067 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Pancrelipase |
Dosage Form Name | CAPSULE, DELAYED RELEASE PELLETS |
Route Name | ORAL |
Start Marketing Date | 20090929 |
Marketing Category Name | NDA |
Labeler Name | Physicians Total Care, Inc. |
Substance Name | PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE |
Strength Number | 60000; 12000; 38000 |
Strength Unit | [USP'U]/1; [USP'U]/1; [USP'U]/1 |
Pharmaceutical Classes |