Prescription drug · NDA AUTHORIZED GENERIC
Azelaic Acid Gel (azelaic acid) NDC 0781-7172
Azelaic acid .15 g/g · Gel · Topical · Sandoz Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-7172-50 | 00781717250 | 1 TUBE in 1 CARTON (0781-7172-50) / 50 g in 1 TUBEMarketed from Oct 1, 2018 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Sandoz Inc.
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021470
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Protein Synthesis (Physiologic effect)Decreased Sebaceous Gland Activity (Physiologic effect)
- Identifiers
- Product ID 0781-7172_d6c8343f-d169-4924-9fa2-4fbf097a32a7SPL ID d6c8343f-d169-4924-9fa2-4fbf097a32a7SPL set ID 66178511-5c1a-4ecd-bc98-2ceb54e710acRxCUI 1041518UNII F2VW3D43YT
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
N400781717250followed by a unit qualifier and the quantityPackage 00781-7172-50. 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. 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 ) 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.
Excerpt only. Read the full label for complete information.