Prescription drug · ANDA
Dapsone NDC 69367-379
Dapsone 100 mg/1 · Tablet · Oral · Westminster Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69367-379-01 | 69367037901 | 100 TABLET in 1 BOTTLE (69367-379-01)Marketed from Jan 16, 2024 | |
| 69367-379-30 | 69367037930 | 30 TABLET in 1 BOTTLE (69367-379-30)Marketed from Jan 16, 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 — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 086842
- Marketing start
- Listing expires
- Other FDA classes
- Sulfones (Chemical structure)
- Identifiers
- Product ID 69367-379_133a7b8c-5bf0-41f7-84e1-7dac278986d7SPL ID 133a7b8c-5bf0-41f7-84e1-7dac278986d7SPL set ID d3fc4934-d48b-4a29-9022-0c82bbdad399RxCUI 197557, 197558UNII 8W5C518302UPC 0369367379304, 0369367378307
- 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
N469367037901followed by a unit qualifier and the quantityPackage 69367-0379-01. 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 086842
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 100 mg/1 | TabletOral | Proficient Rx LP | 82804-989 |
| Dapsone | Dapsone 100 mg/1 | TabletOral | Westminster Pharmaceuticals, LLC | 69367-410 |
| Dapsone 100 mgdapsone tablets | Dapsone 100 mg/1 | TabletOral | Everest Life Sciences. LLC | 83098-101 |