azelaic acid NDC 0591-2131

NDC codes

FDA NDC Directory

Product NDC (as listed)0591-2131Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00591-2131Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0591-2131-55	00591213155	1 TUBE in 1 CARTON (0591-2131-55) / 50 g in 1 TUBEMarketed from Nov 19, 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
Generic name (nonproprietary): azelaic acid
Active ingredients: Azelaic acid — .15 g/g
Dosage form: Gel
Route: Topical
Labeler: Actavis Pharma, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208011
Marketing start: Nov 19, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Protein Synthesis (Physiologic effect)Decreased Sebaceous Gland Activity (Physiologic effect)
Identifiers: Product ID 0591-2131_38d8c966-bb27-4b39-b436-4e7ffbd2d134SPL ID 38d8c966-bb27-4b39-b436-4e7ffbd2d134SPL set ID 66298d50-d4e2-4852-bbab-581389c488cbRxCUI 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

N400591213155 followed by a unit qualifier and the quantity

Package 00591-2131-55. 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 May 30, 2022.

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.

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