| 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] |