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ZENPEP
ZENPEP - 42865-103-04 - (pancrelipase)
Drug Information of ZENPEP
| Product NDC: | 42865-103 |
| Proprietary Name: | ZENPEP |
| Non Proprietary Name: | pancrelipase |
| Active Ingredient(s): | 109000; 20000; 68000 [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) |
Labeler Information of ZENPEP
| Product NDC: | 42865-103 |
| Labeler Name: | Aptalis Pharma US, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022210 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20090922 |
Package Information of ZENPEP
| Package NDC: | 42865-103-04 |
| Package Description: | 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS (42865-103-04) |
NDC Information of ZENPEP
| NDC Code | 42865-103-04 |
| Proprietary Name | ZENPEP |
| Package Description | 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS (42865-103-04) |
| Product NDC | 42865-103 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | pancrelipase |
| Dosage Form Name | CAPSULE, DELAYED RELEASE |
| Route Name | ORAL |
| Start Marketing Date | 20090922 |
| Marketing Category Name | NDA |
| Labeler Name | Aptalis Pharma US, Inc. |
| Substance Name | PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE |
| Strength Number | 109000; 20000; 68000 |
| Strength Unit | [USP'U]/1; [USP'U]/1; [USP'U]/1 |
| Pharmaceutical Classes |
