| Product NDC: | 50458-341 |
| Proprietary Name: | PANCREAZE |
| Non Proprietary Name: | PANCRELIPASE |
| Active Ingredient(s): | 10000; 17500; 4200 [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: | 50458-341 |
| Labeler Name: | Janssen Pharmaceuticals, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022523 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20100412 |
| Package NDC: | 50458-341-60 |
| Package Description: | 1 BOTTLE, GLASS in 1 CARTON (50458-341-60) > 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS |
| NDC Code | 50458-341-60 |
| Proprietary Name | PANCREAZE |
| Package Description | 1 BOTTLE, GLASS in 1 CARTON (50458-341-60) > 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS |
| Product NDC | 50458-341 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | PANCRELIPASE |
| Dosage Form Name | CAPSULE, DELAYED RELEASE |
| Route Name | ORAL |
| Start Marketing Date | 20100412 |
| Marketing Category Name | NDA |
| Labeler Name | Janssen Pharmaceuticals, Inc. |
| Substance Name | PANCRELIPASE; PANCRELIPASE; PANCRELIPASE |
| Strength Number | 10000; 17500; 4200 |
| Strength Unit | [USP'U]/1; [USP'U]/1; [USP'U]/1 |
| Pharmaceutical Classes |