Prescription drug · ANDA
Dapsone NDC 52817-832
Dapsone 75 mg/g · Gel · Topical · Trupharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52817-832-60 | 5281708326052817083260 | 1 TUBE in 1 CARTON (52817-832-60) / 60 g in 1 TUBEMarketed from Nov 20, 2024 | |
| 52817-832-90 | 5281708329052817083290 | 1 TUBE in 1 CARTON (52817-832-90) / 90 g in 1 TUBEMarketed from Nov 20, 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 — 75 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Trupharma, LLCNDC labeler code 52817
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213636
- Marketing start
- Listing expires
- Other FDA classes
- Sulfones (Chemical structure)
- Identifiers
- Product ID 52817-832_3e0fc779-85c7-f2b1-e063-6294a90adc6eSPL ID 3e0fc779-85c7-f2b1-e063-6294a90adc6eSPL set ID 2763bcbb-e249-be2b-e063-6394a90a5015RxCUI 1741905UNII 8W5C518302UPC 0352817832900
- 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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N452817083260followed by a unit qualifier and the quantityPackage 52817-0832-60. 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)
Dapsone gel, 7.5%, is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. Dapsone gel, 7.5%, is a sulfone indicated for the topical treatment of acne vulgaris in patients 9 years of age and older (1) .
Excerpt only. Read the full label for complete information.
About NDC 52817-832
- What is NDC 52817-832?
- 52817-832 is the product NDC for Dapsone, Dapsone 75 mg/g gel, listed with the FDA by Trupharma, LLC. 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?
- Trupharma, LLC, NDC labeler code 52817. 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 |