Prescription drug · ANDA
Dapsone NDC 69367-409
Dapsone 25 mg/1 · Tablet · Oral · Westminster Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69367-409-01 | 69367040901 | 100 TABLET in 1 BOTTLE (69367-409-01)Marketed from Aug 21, 2025 | |
| 69367-409-30 | 69367040930 | 30 TABLET in 1 BOTTLE (69367-409-30)Marketed from Aug 21, 2025 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 086841
- Marketing start
- Listing expires
- Other FDA classes
- Sulfones (Chemical structure)
- Identifiers
- Product ID 69367-409_94a7ec84-91fc-4cb2-9ddc-49e82e94408fSPL ID 94a7ec84-91fc-4cb2-9ddc-49e82e94408fSPL set ID 7d317576-5edd-4c27-a00d-68b5944c04a8RxCUI 197557, 197558UNII 8W5C518302UPC 0369367410304, 0369367409308
- 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
N469367040901followed by a unit qualifier and the quantityPackage 69367-0409-01. 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 .
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.
Other NDCs under ANDA 086841
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Dapsone | Dapsone 25 mg/1 | TabletOral | AvKARE | 73190-037 |
| Dapsone | Dapsone 25 mg/1 | TabletOral | Proficient Rx LP | 82804-988 |
| Dapsone | Dapsone 25 mg/1 | TabletOral | Westminster Pharmaceuticals, LLC | 69367-378 |
| Dapsone 25 mgdapsone tablets | Dapsone 25 mg/1 | TabletOral | Everest Life Sciences. LLC | 83098-102 |
| Dapsone | Dapsone 25 mg/1 | TabletOral | AvKARE | 42291-008 |