What is NDC 68462-626?

68462-626 is the product NDC for azelaic acid, Azelaic acid .15 g/g gel, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 1 package NDC, shown above in 10- and 11-digit form.

Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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 68462-626 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-626Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0626Add 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
68462-626-52	6846206265268462062652	1 TUBE in 1 CARTON (68462-626-52) / 50 g in 1 TUBEMarketed from Nov 19, 2018

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): azelaic acid
Generic name (nonproprietary): azelaic acid
Active ingredients: Azelaic acid — .15 g/g
Dosage form: Gel
Route: Topical
Labeler: Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204637
Marketing start: Nov 19, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Protein Synthesis (Physiologic effect)Decreased Sebaceous Gland Activity (Physiologic effect)
Identifiers: Product ID 68462-626_28cca0c1-2f38-4fa2-8aaf-d3c8978b0fc6SPL ID 28cca0c1-2f38-4fa2-8aaf-d3c8978b0fc6SPL set ID 0b5ab22e-c78a-4429-9a76-a4ba2d11fcdeRxCUI 1041518UNII F2VW3D43YTUPC 0368462626528

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

N468462062652 followed by a unit qualifier and the quantity

Package 68462-0626-52. 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 Dec 23, 2021.

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)

About NDC 68462-626

What is NDC 68462-626?: 68462-626 is the product NDC for azelaic acid, Azelaic acid .15 g/g gel, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. 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?: Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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	Sun Pharmaceutical Industries, Inc.	51672-1389	51672-1389-03
azelaic acid	Azelaic acid .15 g/g	GelTopical	Actavis Pharma, Inc.	0591-2131	00591-2131-55