| Product NDC: | 62559-111 |
| Proprietary Name: | Cortenema |
| Non Proprietary Name: | Hydrocortisone |
| Active Ingredient(s): | 100 mg/60mL & nbsp; Hydrocortisone |
| Administration Route(s): | RECTAL |
| Dosage Form(s): | ENEMA |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 62559-111 |
| Labeler Name: | ANIP Acquisition Company |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA016199 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20120810 |
| Package NDC: | 62559-111-07 |
| Package Description: | 7 BOTTLE, UNIT-DOSE in 1 CARTON (62559-111-07) > 60 mL in 1 BOTTLE, UNIT-DOSE |
| NDC Code | 62559-111-07 |
| Proprietary Name | Cortenema |
| Package Description | 7 BOTTLE, UNIT-DOSE in 1 CARTON (62559-111-07) > 60 mL in 1 BOTTLE, UNIT-DOSE |
| Product NDC | 62559-111 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Hydrocortisone |
| Dosage Form Name | ENEMA |
| Route Name | RECTAL |
| Start Marketing Date | 20120810 |
| Marketing Category Name | NDA |
| Labeler Name | ANIP Acquisition Company |
| Substance Name | HYDROCORTISONE |
| Strength Number | 100 |
| Strength Unit | mg/60mL |
| Pharmaceutical Classes | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |