NDC 10922-825
Finacea
Azelaic Acid
Finacea is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Intendis Inc.. The primary component is Azelaic Acid.
| Product ID | 10922-825_a7594a20-f46e-4b33-91d5-410cc5e97b8d |
| NDC | 10922-825 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Finacea |
| Generic Name | Azelaic Acid |
| Dosage Form | Gel |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2004-12-24 |
| Marketing Category | NDA / NDA |
| Application Number | NDA021470 |
| Labeler Name | Intendis Inc. |
| Substance Name | AZELAIC ACID |
| Active Ingredient Strength | 0 g/g |
| Pharm Classes | Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
Packaging
NDC 10922-825-02
1 TUBE in 1 CARTON (10922-825-02) > 50 g in 1 TUBE
| Marketing Start Date | 2004-12-24 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 10922-825-02 [10922082502]
Finacea GEL
| Marketing Category | NDA |
| Application Number | NDA021470 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2004-12-24 |
| Inactivation Date | 2019-11-27 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| AZELAIC ACID | .15 g/g |
OpenFDA Data
| SPL SET ID: | 63773349-0295-4d56-a72e-0d7cade88ddb |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Decreased Protein Synthesis [PE]
- Decreased Sebaceous Gland Activity [PE]
Medicade Reported Pricing
10922082502 FINACEA 15% GEL
Pricing Unit: GM | Drug Type:
NDC Crossover Matching brand name "Finacea" or generic name "Azelaic Acid"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 10922-825 | Finacea | azelaic acid |
| 10922-826 | Finacea | azelaic acid |
| 50090-3032 | Finacea | azelaic acid |
| 50090-4473 | Finacea | azelaic acid |
| 50222-505 | Finacea | azelaic acid |
| 50419-825 | Finacea | azelaic acid |
| 0115-1624 | Azelaic Acid | Azelaic Acid |
| 0591-2131 | azelaic acid | azelaic acid |
| 51672-1389 | Azelaic Acid | Azelaic Acid |
| 68462-626 | azelaic acid | azelaic acid |
| 0781-7172 | Azelaic Acid Gel | azelaic acid |
| 0023-8694 | AZELEX | azelaic acid |
| 16110-869 | AZELEX | azelaic acid |
| 50222-303 | FINACEA FOAM | azelaic acid |
| 50419-829 | FINACEA FOAM | azelaic acid |
Trademark Results [Finacea]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FINACEA 76325515 2811242 Live/Registered |
LEO PHARMA A/S 2001-10-12 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.