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NDC 21922-0038-14 Azelaic Acid Gel 0.15 g/g Details
Azelaic Acid Gel 0.15 g/g
Azelaic Acid Gel is a TOPICAL GEL in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Encube Ethicals Private Limited. The primary component is AZELAIC ACID.
MedlinePlus Drug Summary
Azelaic acid gel and foam is used to clear the bumps, lesions, and swelling caused by rosacea (a skin disease that causes redness, flushing, and pimples on the face). Azelaic acid cream is used to treat the pimples and swelling caused by acne. Azelaic acid is in a class of medications called dicarboxylic acids. It works to treat rosacea by decreasing the swelling and redness of the skin. It works to treat acne by killing the bacteria that infect pores and by decreasing production of keratin, a natural substance that can lead to the development of acne.
Related Packages: 21922-0038-14Last Updated: 03/24/2024
MedLinePlus Full Drug Details: Azelaic Acid Topical
Product Information
| NDC | 21922-0038 |
|---|---|
| Product ID | 21922-038_ab3f174c-a3c4-4ae9-b0bc-954efaadf8de |
| Associated GPIs | |
| GCN Sequence Number | 051812 |
| GCN Sequence Number Description | azelaic acid GEL (GRAM) 15 % TOPICAL |
| HIC3 | L5G |
| HIC3 Description | ROSACEA AGENTS, TOPICAL |
| GCN | 19198 |
| HICL Sequence Number | 007471 |
| HICL Sequence Number Description | AZELAIC ACID |
| Brand/Generic | Generic |
| Proprietary Name | Azelaic Acid Gel |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Azelaic Acid |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | GEL |
| Route | TOPICAL |
| Active Ingredient Strength | 0.15 |
| Active Ingredient Units | g/g |
| Substance Name | AZELAIC ACID |
| Labeler Name | Encube Ethicals Private Limited |
| Pharmaceutical Class | Decreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA208724 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 21922-0038-14 (21922003814)
| NDC Package Code | 21922-038-14 |
|---|---|
| Billing NDC | 21922003814 |
| Package | 1 TUBE in 1 CARTON (21922-038-14) / 50 g in 1 TUBE |
| Marketing Start Date | 2023-11-30 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.77944 |
| Pricing Unit | GM |
| Effective Date | 2024-02-21 |
| NDC Description | AZELAIC ACID 15% GEL |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
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