Azelex (azelaic acid) NDC 16110-869

NDC codes

FDA NDC Directory

Product NDC (as listed)16110-869Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16110-0869Add 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
16110-869-30	16110086930	1 TUBE in 1 CARTON (16110-869-30) / 30 g in 1 TUBEMarketed from Jul 12, 2019
16110-869-50	16110086950	1 TUBE in 1 CARTON (16110-869-50) / 50 g in 1 TUBEMarketed from Jul 12, 2019

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): Azelex
Generic name (nonproprietary): azelaic acid
Active ingredients: Azelaic acid — .2 g/g
Dosage form: Cream
Route: Cutaneous
Labeler: Almirall, LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020428
Marketing start: Sep 24, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Protein Synthesis (Physiologic effect)Decreased Sebaceous Gland Activity (Physiologic effect)
Identifiers: Product ID 16110-869_ae821f0c-ec53-4612-a505-e1aa9d73a158SPL ID ae821f0c-ec53-4612-a505-e1aa9d73a158SPL set ID ebdfcaf7-b5d6-47e1-be87-ccaba4b97e75RxCUI 1041520, 1043753UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N416110086930 followed by a unit qualifier and the quantity

Package 16110-0869-30. 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 Mar 4, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE AZELEX ® cream is indicated for the topical treatment of mild-to-moderate inflammatory acne vulgaris.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)