Prescription drug · ANDA
Dapsone 25 mg (Dapsone tablets) NDC 83098-102
Dapsone 25 mg/1 · Tablet · Oral · Everest Life Sciences. LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83098-102-01 | 8309801020183098010201 | 100 TABLET in 1 BOTTLE (83098-102-01)Marketed from Sep 1, 2024 | |
| 83098-102-03 | 8309801020383098010203 | 30 TABLET in 1 BOTTLE (83098-102-03)Marketed from Sep 1, 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 25 mg
- Generic name (nonproprietary)
- dapsone tablets
- Active ingredients
- Dapsone — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Everest Life Sciences. LLCNDC labeler code 83098
- 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 83098-102_2127568d-553c-c142-e063-6394a90a4ef7SPL ID 2127568d-553c-c142-e063-6394a90a4ef7SPL set ID 1d026bb6-05da-e9cf-e063-6394a90a2485RxCUI 197557, 197558UNII 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N483098010201followed by a unit qualifier and the quantityPackage 83098-0102-01. 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.
About NDC 83098-102
- What is NDC 83098-102?
- 83098-102 is the product NDC for Dapsone 25 mg (dapsone tablets), Dapsone 25 mg/1 tablet, listed with the FDA by Everest Life Sciences. LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dapsone 25 mg (Dapsone Tablets).
- What is the active ingredient?
- Dapsone.
- Who is the labeler?
- Everest Life Sciences. LLC, NDC labeler code 83098. 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 25 mg?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 | 42291-008 |
| Dapsone | Dapsone 25 mg/1 | TabletOral | Westminster Pharmaceuticals, LLC | 69367-378 |
| Dapsone | Dapsone 25 mg/1 | TabletOral | Westminster Pharmaceuticals, LLC | 69367-409 |
| Dapsone | Dapsone 25 mg/1 | TabletOral | AvKARE | 73190-037 |
| Dapsone | Dapsone 25 mg/1 | TabletOral | Proficient Rx LP | 82804-988 |