Dapsone NDC 51862-123

NDC codes

FDA NDC Directory

Product NDC (as listed)51862-123Labeler and product segments. Claims need a package NDC.

Product NDC at billing width51862-0123Add 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
51862-123-60	51862012360	1 TUBE in 1 CARTON (51862-123-60) / 60 g in 1 TUBEMarketed from Feb 14, 2024

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): Dapsone
Generic name (nonproprietary): dapsone
Active ingredients: Dapsone — 50 mg/g
Dosage form: Gel
Route: Topical
Labeler: Mayne Pharma
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212383
Marketing start: Feb 14, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Sulfones (Chemical structure)
Identifiers: Product ID 51862-123_45c41a7a-58d6-48fd-bfe3-f9bc9508c335SPL ID 45c41a7a-58d6-48fd-bfe3-f9bc9508c335SPL set ID dc495e54-8917-42de-a9fa-1f961bd99d61RxCUI 607295UNII 8W5C518302
Pharmacologic class: Sulfone

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

N451862012360 followed by a unit qualifier and the quantity

Package 51862-0123-60. 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 Jan 31, 2024.

Indications (excerpt from the label)

Dapsone gel, 5%, is indicated for the topical treatment of acne vulgaris. Dapsone gel is indicated for the topical treatment of acne vulgaris ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 212383

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

FDA NDC Directory listings under ANDA 212383
Product	Strength	Form · route	Labeler	Product NDC
Dapsonedapsone gel, 5%	Dapsone 50 mg/g	GelTopical	Encube Ethicals, Inc.	21922-018