Azelaic Acid Gel (azelaic acid) NDC 72162-2297

NDC codes

FDA NDC Directory

Product NDC (as listed)72162-2297Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72162-2297Add 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
72162-2297-2	72162229702	1 TUBE in 1 CARTON (72162-2297-2) / 50 g in 1 TUBEMarketed from Nov 30, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208724
Marketing start: Nov 30, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Protein Synthesis (Physiologic effect)Decreased Sebaceous Gland Activity (Physiologic effect)
Identifiers: Product ID 72162-2297_92d67e5a-c010-4edf-bce7-858c8a4cc818SPL ID 92d67e5a-c010-4edf-bce7-858c8a4cc818SPL set ID 9c151fc7-cb0b-4931-9c1b-0c29f46ac21fRxCUI 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

N472162229702 followed by a unit qualifier and the quantity

Package 72162-2297-02. 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 21, 2026.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 208724

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 208724
Product	Strength	Form · route	Labeler	Product NDC
Azelaic Acid Gelazelaic acid	Azelaic acid .15 g/g	GelTopical	Encube Ethicals, Inc.	21922-038