Dapsone NDC 21922-018

NDC codes

FDA NDC Directory

Product NDC (as listed)21922-018Labeler and product segments. Claims need a package NDC.

Product NDC at billing width21922-0018Add 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
21922-018-07	21922001807	1 TUBE in 1 CARTON (21922-018-07) / 60 g in 1 TUBEMarketed from Oct 16, 2023
21922-018-08	21922001808	1 TUBE in 1 CARTON (21922-018-08) / 90 g in 1 TUBEMarketed from Oct 16, 2023

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 gel, 5%
Active ingredients: Dapsone — 50 mg/g
Dosage form: Gel
Route: Topical
Labeler: Encube Ethicals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212383
Marketing start: Oct 16, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Sulfones (Chemical structure)
Identifiers: Product ID 21922-018_4805ec1d-1a52-438d-8601-2878f5f40e08SPL ID 4805ec1d-1a52-438d-8601-2878f5f40e08SPL set ID 4205a1a9-c459-47bb-9538-1dd559ca71f1RxCUI 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

N421922001807 followed by a unit qualifier and the quantity

Package 21922-0018-07. 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 Oct 31, 2025.

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.

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
Dapsone	Dapsone 50 mg/g	GelTopical	Mayne Pharma	51862-123