Azelaic Acid NDC 51672-1389

NDC codes

FDA NDC Directory

Product NDC (as listed)51672-1389Labeler and product segments. Claims need a package NDC.

Product NDC at billing width51672-1389Add 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
51672-1389-3	51672138903	1 TUBE in 1 CARTON (51672-1389-3) / 50 g in 1 TUBEMarketed from Aug 23, 2019

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
Generic name (nonproprietary): azelaic acid
Active ingredients: Azelaic acid — .15 g/g
Dosage form: Gel
Route: Topical
Labeler: Sun Pharmaceutical Industries, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210549
Marketing start: Aug 23, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Protein Synthesis (Physiologic effect)Decreased Sebaceous Gland Activity (Physiologic effect)
Identifiers: Product ID 51672-1389_3cf92843-22fd-ba71-e063-6294a90a1fc6SPL ID 3cf92843-22fd-ba71-e063-6294a90a1fc6SPL set ID d4e9e95d-1ebd-44df-a91e-59819715659cRxCUI 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

N451672138903 followed by a unit qualifier and the quantity

Package 51672-1389-03. 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 Aug 22, 2025.

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.

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