Prescription drug · ANDA
Azelaic Acid Gel (Azelaic acid) NDC 21922-038
Azelaic acid .15 g/g · Gel · Topical · Encube Ethicals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 21922-038-14 | 2192200381421922003814 | 1 TUBE in 1 CARTON (21922-038-14) / 50 g in 1 TUBEMarketed from Nov 30, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Azelaic Acid Gel
- Generic name (nonproprietary)
- azelaic acid
- Active ingredients
- Azelaic acid — .15 g/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Encube Ethicals, Inc.NDC labeler code 21922
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208724
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Protein Synthesis (Physiologic effect)Decreased Sebaceous Gland Activity (Physiologic effect)
- Identifiers
- Product ID 21922-038_433f2929-0ee4-4b1f-a548-eff7b66e7fb6SPL ID 433f2929-0ee4-4b1f-a548-eff7b66e7fb6SPL set ID ab3f174c-a3c4-4ae9-b0bc-954efaadf8deRxCUI 1041518UNII F2VW3D43YTUPC 0321922038149
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N421922003814followed by a unit qualifier and the quantityPackage 21922-0038-14. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Azelaic Acid Gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Limitations of Use Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. Azelaic Acid Gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea ( 1 ). Limitations of Use Efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 21922-038
- What is NDC 21922-038?
- 21922-038 is the product NDC for Azelaic Acid Gel (azelaic acid), Azelaic acid .15 g/g gel, listed with the FDA by Encube Ethicals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Azelaic Acid Gel (Azelaic Acid).
- What is the active ingredient?
- Azelaic acid.
- Who is the labeler?
- Encube Ethicals, Inc., NDC labeler code 21922. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Azelaic Acid Gel?
- 2 other product NDCs are listed under this name. See all Azelaic Acid Gel NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Azelaic Acid Gel products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Azelaic Acid Gelazelaic acid | Azelaic acid .15 g/g | GelTopical | Bryant Ranch Prepack | 72162-2297 | 72162-2297-02 |
| Azelaic Acid Gelazelaic acid | Azelaic acid .15 g/g | GelTopical | Sandoz Inc. | 0781-7172 | 00781-7172-50 |
Other NDCs under ANDA 208724
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Azelaic Acid Gelazelaic acid | Azelaic acid .15 g/g | GelTopical | Bryant Ranch Prepack | 72162-2297 |