Product NDC: | 51991-728 |
Proprietary Name: | Hydrocortisone |
Non Proprietary Name: | Hydrocortisone |
Active Ingredient(s): | 100 mg/60mL & nbsp; Hydrocortisone |
Administration Route(s): | RECTAL |
Dosage Form(s): | SUSPENSION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 51991-728 |
Labeler Name: | Breckenridge Pharmaceutical, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA016199 |
Marketing Category: | NDA |
Start Marketing Date: | 20101015 |
Package NDC: | 51991-728-67 |
Package Description: | 7 BOTTLE, WITH APPLICATOR in 1 BOX (51991-728-67) > 60 mL in 1 BOTTLE, WITH APPLICATOR (51991-728-99) |
NDC Code | 51991-728-67 |
Proprietary Name | Hydrocortisone |
Package Description | 7 BOTTLE, WITH APPLICATOR in 1 BOX (51991-728-67) > 60 mL in 1 BOTTLE, WITH APPLICATOR (51991-728-99) |
Product NDC | 51991-728 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Hydrocortisone |
Dosage Form Name | SUSPENSION |
Route Name | RECTAL |
Start Marketing Date | 20101015 |
Marketing Category Name | NDA |
Labeler Name | Breckenridge Pharmaceutical, Inc. |
Substance Name | HYDROCORTISONE |
Strength Number | 100 |
Strength Unit | mg/60mL |
Pharmaceutical Classes | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |