| Product NDC: | 59767-016 |
| Proprietary Name: | PERTZYE |
| Non Proprietary Name: | pancrelipase |
| Active Ingredient(s): | 60500; 16000; 57500 [USP'U]/1; [USP'U]/1; [USP'U]/1 & nbsp; pancrelipase |
| Administration Route(s): | ORAL |
| Dosage Form(s): | CAPSULE, DELAYED RELEASE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 59767-016 |
| Labeler Name: | Digestive Care, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022175 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20120517 |
| Package NDC: | 59767-016-01 |
| Package Description: | 1 BOTTLE in 1 CARTON (59767-016-01) > 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE |
| NDC Code | 59767-016-01 |
| Proprietary Name | PERTZYE |
| Package Description | 1 BOTTLE in 1 CARTON (59767-016-01) > 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE |
| Product NDC | 59767-016 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | pancrelipase |
| Dosage Form Name | CAPSULE, DELAYED RELEASE |
| Route Name | ORAL |
| Start Marketing Date | 20120517 |
| Marketing Category Name | NDA |
| Labeler Name | Digestive Care, Inc. |
| Substance Name | PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE |
| Strength Number | 60500; 16000; 57500 |
| Strength Unit | [USP'U]/1; [USP'U]/1; [USP'U]/1 |
| Pharmaceutical Classes |