Product NDC: | 68084-213 |
Proprietary Name: | Ursodiol |
Non Proprietary Name: | Ursodiol |
Active Ingredient(s): | 300 mg/1 & nbsp; Ursodiol |
Administration Route(s): | ORAL |
Dosage Form(s): | CAPSULE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 68084-213 |
Labeler Name: | American Health Packaging |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA019594 |
Marketing Category: | NDA |
Start Marketing Date: | 20091105 |
Package NDC: | 68084-213-01 |
Package Description: | 10 BLISTER PACK in 1 CARTON (68084-213-01) > 10 CAPSULE in 1 BLISTER PACK (68084-213-11) |
NDC Code | 68084-213-01 |
Proprietary Name | Ursodiol |
Package Description | 10 BLISTER PACK in 1 CARTON (68084-213-01) > 10 CAPSULE in 1 BLISTER PACK (68084-213-11) |
Product NDC | 68084-213 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Ursodiol |
Dosage Form Name | CAPSULE |
Route Name | ORAL |
Start Marketing Date | 20091105 |
Marketing Category Name | NDA |
Labeler Name | American Health Packaging |
Substance Name | URSODIOL |
Strength Number | 300 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] |