What is NDC 51672-1389?

51672-1389 is the product NDC for Azelaic Acid, Azelaic acid .15 g/g gel, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Sun Pharmaceutical Industries, Inc., NDC labeler code 51672. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Azelaic Acid?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Azelaic Acid NDC 51672-1389 | National Drug Code

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	5167213890351672138903	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.NDC labeler code 51672
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.

Full label on DailyMed (opens in a new tab)

About NDC 51672-1389

What is NDC 51672-1389?: 51672-1389 is the product NDC for Azelaic Acid, Azelaic acid .15 g/g gel, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Azelaic Acid.
What is the active ingredient?: Azelaic acid.
Who is the labeler?: Sun Pharmaceutical Industries, Inc., NDC labeler code 51672. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Azelaic Acid?: 2 other product NDCs are listed under this name. See all Azelaic Acid NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Azelaic Acid NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
azelaic acid	Azelaic acid .15 g/g	GelTopical	Actavis Pharma, Inc.	0591-2131	00591-2131-55
azelaic acid	Azelaic acid .15 g/g	GelTopical	Glenmark Pharmaceuticals Inc., USA	68462-626	68462-0626-52