| Product NDC: | 64980-301 |
| Proprietary Name: | Proctozone |
| Non Proprietary Name: | hydrocortisone |
| Active Ingredient(s): | 25 mg/g & nbsp; hydrocortisone |
| Administration Route(s): | TOPICAL |
| Dosage Form(s): | CREAM |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 64980-301 |
| Labeler Name: | Rising Pharmaceuticals, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA089682 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20120501 |
| Package NDC: | 64980-301-30 |
| Package Description: | 1 TUBE in 1 CARTON (64980-301-30) > 30 g in 1 TUBE |
| NDC Code | 64980-301-30 |
| Proprietary Name | Proctozone |
| Package Description | 1 TUBE in 1 CARTON (64980-301-30) > 30 g in 1 TUBE |
| Product NDC | 64980-301 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | hydrocortisone |
| Dosage Form Name | CREAM |
| Route Name | TOPICAL |
| Start Marketing Date | 20120501 |
| Marketing Category Name | ANDA |
| Labeler Name | Rising Pharmaceuticals, Inc. |
| Substance Name | HYDROCORTISONE |
| Strength Number | 25 |
| Strength Unit | mg/g |
| Pharmaceutical Classes | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |