| Product NDC: | 54868-5236 |
| Proprietary Name: | Finacea |
| Non Proprietary Name: | azelaic acid |
| Active Ingredient(s): | .15 g/g & nbsp; azelaic acid |
| Administration Route(s): | TOPICAL |
| Dosage Form(s): | GEL |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 54868-5236 |
| Labeler Name: | Physicians Total Care, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021470 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20050303 |
| Package NDC: | 54868-5236-1 |
| Package Description: | 1 TUBE in 1 CARTON (54868-5236-1) > 50 g in 1 TUBE |
| NDC Code | 54868-5236-1 |
| Proprietary Name | Finacea |
| Package Description | 1 TUBE in 1 CARTON (54868-5236-1) > 50 g in 1 TUBE |
| Product NDC | 54868-5236 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | azelaic acid |
| Dosage Form Name | GEL |
| Route Name | TOPICAL |
| Start Marketing Date | 20050303 |
| Marketing Category Name | NDA |
| Labeler Name | Physicians Total Care, Inc. |
| Substance Name | AZELAIC ACID |
| Strength Number | .15 |
| Strength Unit | g/g |
| Pharmaceutical Classes | Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE] |