Dapsone NDC 33342-534

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-534Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0534Add 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
33342-534-07	33342053407	30 TABLET in 1 BOTTLE (33342-534-07)Marketed from Jul 8, 2026
33342-534-11	33342053411	100 TABLET in 1 BOTTLE (33342-534-11)Marketed from Jul 8, 2026

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 — 25 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Macleods Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218335
Marketing start: Jul 8, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Sulfones (Chemical structure)
Identifiers: Product ID 33342-534_839d7440-ba0e-4c56-b648-d374b155cf03SPL ID 839d7440-ba0e-4c56-b648-d374b155cf03SPL set ID 839d7440-ba0e-4c56-b648-d374b155cf03RxCUI 197557, 197558UNII 8W5C518302UPC 0333342535078, 0333342535115, 0333342534071, 0333342534118
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N433342053407 followed by a unit qualifier and the quantity

Package 33342-0534-07. 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 Jul 20, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Dermatitis herpetiformis: (D.H.) Leprosy: All forms of leprosy except for cases of proven dapsone resistance.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 218335

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

FDA NDC Directory listings under ANDA 218335
Product	Strength	Form · route	Labeler	Product NDC
Dapsone	Dapsone 100 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-535