Prescription drug · ANDA
Dapsone NDC 82804-988
Dapsone 25 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-988-00 | 8280409880082804098800 | 100 TABLET in 1 BOTTLE (82804-988-00)Marketed from May 21, 2024 | |
| 82804-988-11 | 8280409881182804098811 | 1000 TABLET in 1 BOTTLE (82804-988-11)Marketed from May 21, 2024 | |
| 82804-988-30 | 8280409883082804098830 | 30 TABLET in 1 BOTTLE (82804-988-30)Marketed from May 21, 2024 | |
| 82804-988-55 | 8280409885582804098855 | 500 TABLET in 1 BOTTLE (82804-988-55)Marketed from May 21, 2024 | |
| 82804-988-60 | 8280409886082804098860 | 60 TABLET in 1 BOTTLE (82804-988-60)Marketed from May 21, 2024 | |
| 82804-988-64 | 8280409886482804098864 | 240 TABLET in 1 BOTTLE (82804-988-64)Marketed from May 21, 2024 | |
| 82804-988-72 | 8280409887282804098872 | 120 TABLET in 1 BOTTLE (82804-988-72)Marketed from May 21, 2024 | |
| 82804-988-78 | 8280409887882804098878 | 180 TABLET in 1 BOTTLE (82804-988-78)Marketed from May 21, 2024 | |
| 82804-988-90 | 8280409889082804098890 | 90 TABLET in 1 BOTTLE (82804-988-90)Marketed from May 21, 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 — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 82804
- 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 82804-988_9cfe5fe7-abc7-4f48-a597-1b1a5c70a354SPL ID 9cfe5fe7-abc7-4f48-a597-1b1a5c70a354SPL set ID 9cfe5fe7-abc7-4f48-a597-1b1a5c70a354RxCUI 197557, 197558UNII 8W5C518302UPC 0382804989300, 0382804988303
- 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
N482804098800followed by a unit qualifier and the quantityPackage 82804-0988-00. 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 82804-988
- What is NDC 82804-988?
- 82804-988 is the product NDC for Dapsone, Dapsone 25 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 9 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?
- Proficient Rx LP, NDC labeler code 82804. 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 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 25 mgdapsone tablets | Dapsone 25 mg/1 | TabletOral | Everest Life Sciences. LLC | 83098-102 |