Prescription drug · ANDA
Dapsone NDC 83209-566
Dapsone 100 mg/1 · Tablet · Oral · Boswell Pharmacy Services LLC d/b/a BPS Wholesale
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83209-566-30 | 8320905663083209056630 | 30 TABLET in 1 BLISTER PACK (83209-566-30)Marketed from Aug 30, 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
- Labeler
- Boswell Pharmacy Services LLC d/b/a BPS WholesaleNDC labeler code 83209
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207165
- Marketing start
- Listing expires
- Other FDA classes
- Sulfones (Chemical structure)
- Identifiers
- Product ID 83209-566_20e8edf4-4458-c1da-e063-6394a90aa891SPL ID 20e8edf4-4458-c1da-e063-6394a90aa891SPL set ID 20e8ca55-513e-8935-e063-6394a90a11cdRxCUI 197557UNII 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
N483209056630followed by a unit qualifier and the quantityPackage 83209-0566-30. 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 & 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 83209-566
- What is NDC 83209-566?
- 83209-566 is the product NDC for Dapsone, Dapsone 100 mg/1 tablet, listed with the FDA by Boswell Pharmacy Services LLC d/b/a BPS Wholesale. It has 1 package NDC, 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?
- Boswell Pharmacy Services LLC d/b/a BPS Wholesale, NDC labeler code 83209. 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.
Related NDCs: other Dapsone products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 100 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-535 | 33342-0535-0733342-0535-11 |
| 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 |
Other NDCs under ANDA 207165
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 | Rising Pharma Holdings, Inc. | 64980-566 |
| Dapsone | Dapsone 25 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-567 |
| Dapsone | Dapsone 100 mg/1 | TabletOral | Coupler LLC | 67046-1477 |