Product NDC: | 54092-189 |
Proprietary Name: | Pentasa |
Non Proprietary Name: | mesalamine |
Active Ingredient(s): | 250 mg/1 & nbsp; mesalamine |
Administration Route(s): | ORAL |
Dosage Form(s): | CAPSULE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 54092-189 |
Labeler Name: | Shire US Manufacturing Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA020049 |
Marketing Category: | NDA |
Start Marketing Date: | 19930510 |
Package NDC: | 54092-189-81 |
Package Description: | 240 CAPSULE in 1 BOTTLE (54092-189-81) |
NDC Code | 54092-189-81 |
Proprietary Name | Pentasa |
Package Description | 240 CAPSULE in 1 BOTTLE (54092-189-81) |
Product NDC | 54092-189 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | mesalamine |
Dosage Form Name | CAPSULE |
Route Name | ORAL |
Start Marketing Date | 19930510 |
Marketing Category Name | NDA |
Labeler Name | Shire US Manufacturing Inc. |
Substance Name | MESALAMINE |
Strength Number | 250 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] |