Azelaic Acid is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Of New York Llc. The primary component is Azelaic Acid.
| Product ID | 0115-1624_8adcda98-4dc1-4379-84b8-c16b122c16d1 |
| NDC | 0115-1624 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Azelaic Acid |
| Generic Name | Azelaic Acid |
| Dosage Form | Gel |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2018-11-19 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA208724 |
| Labeler Name | Amneal Pharmaceuticals of New York LLC |
| Substance Name | AZELAIC ACID |
| Active Ingredient Strength | 0 g/g |
| Pharm Classes | Decreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2018-11-19 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA208724 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2018-11-19 |
| Ingredient | Strength |
|---|---|
| AZELAIC ACID | .15 g/g |
| SPL SET ID: | ed69bd06-9eae-4354-9250-dc92e16480ac |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 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 |
| 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 |
| 50222-303 | FINACEA FOAM | azelaic acid |
| 50419-829 | FINACEA FOAM | azelaic acid |