What is NDC 33342-535?

33342-535 is the product NDC for Dapsone, Dapsone 100 mg/1 tablet, listed with the FDA by Macleods Pharmaceuticals Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Macleods Pharmaceuticals Limited, NDC labeler code 33342. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Dapsone?

45 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Dapsone NDC 33342-535 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-535Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0535Add 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
33342-535-07	3334205350733342053507	30 TABLET in 1 BOTTLE (33342-535-07)Marketed from Jul 8, 2026
33342-535-11	3334205351133342053511	100 TABLET in 1 BOTTLE (33342-535-11)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 — 100 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Macleods Pharmaceuticals LimitedNDC labeler code 33342
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 33342-535_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

N433342053507 followed by a unit qualifier and the quantity

Package 33342-0535-07. 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)

About NDC 33342-535

What is NDC 33342-535?: 33342-535 is the product NDC for Dapsone, Dapsone 100 mg/1 tablet, listed with the FDA by Macleods Pharmaceuticals Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Dapsone.
What is the active ingredient?: Dapsone.
Who is the labeler?: Macleods Pharmaceuticals Limited, NDC labeler code 33342. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dapsone?: 45 other product NDCs are listed under this name. See all Dapsone 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 Dapsone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Dapsone	Dapsone 25 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-534	33342-0534-0733342-0534-11
Dapsone	Dapsone 50 mg/g	GelTopical	Alembic Pharmaceuticals Limited	46708-551	46708-0551-3046708-0551-6046708-0551-90
Dapsone	Dapsone 50 mg/g	GelTopical	Alembic Pharmaceuticals Inc.	62332-551	62332-0551-3062332-0551-6062332-0551-90
Dapsone	Dapsone 25 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1979	70771-1979-0170771-1979-03
Dapsone	Dapsone 100 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1980	70771-1980-0170771-1980-03
Dapsone	Dapsone 25 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-177	72578-0177-0172578-0177-06
Dapsone	Dapsone 100 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-178	72578-0178-0172578-0178-06
Dapsone	Dapsone 25 mg/1	TabletOral	AvKARE	73190-037	73190-0037-01
Dapsone	Dapsone 25 mg/1	TabletOral	Westminster Pharmaceuticals, LLC	69367-409	69367-0409-0169367-0409-30
Dapsone	Dapsone 100 mg/1	TabletOral	Westminster Pharmaceuticals, LLC	69367-410	69367-0410-0169367-0410-30

All 46 Dapsone NDCs

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 25 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-534