| Product NDC: | 64980-302 | 
| Proprietary Name: | Procto-Pak | 
| Non Proprietary Name: | hydrocortisone | 
| Active Ingredient(s): | 10 mg/g & nbsp; hydrocortisone | 
| Administration Route(s): | TOPICAL | 
| Dosage Form(s): | CREAM | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 64980-302 | 
| Labeler Name: | Rising Pharmaceuticals, Inc. | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | ANDA087795 | 
| Marketing Category: | ANDA | 
| Start Marketing Date: | 20120601 | 
| Package NDC: | 64980-302-30 | 
| Package Description: | 1 TUBE in 1 CARTON (64980-302-30) > 28 g in 1 TUBE | 
| NDC Code | 64980-302-30 | 
| Proprietary Name | Procto-Pak | 
| Package Description | 1 TUBE in 1 CARTON (64980-302-30) > 28 g in 1 TUBE | 
| Product NDC | 64980-302 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | hydrocortisone | 
| Dosage Form Name | CREAM | 
| Route Name | TOPICAL | 
| Start Marketing Date | 20120601 | 
| Marketing Category Name | ANDA | 
| Labeler Name | Rising Pharmaceuticals, Inc. | 
| Substance Name | HYDROCORTISONE | 
| Strength Number | 10 | 
| Strength Unit | mg/g | 
| Pharmaceutical Classes | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |