Prescription drug · ANDA
Dapsone NDC 62332-663
Dapsone 75 mg/g · Gel · Topical · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-663-30 | 62332066330 | 1 BOTTLE, PUMP in 1 CARTON (62332-663-30) / 30 g in 1 BOTTLE, PUMPMarketed from Oct 30, 2023 | |
| 62332-663-60 | 62332066360 | 1 BOTTLE, PUMP in 1 CARTON (62332-663-60) / 60 g in 1 BOTTLE, PUMPMarketed from Oct 30, 2023 | |
| 62332-663-90 | 62332066390 | 1 BOTTLE, PUMP in 1 CARTON (62332-663-90) / 90 g in 1 BOTTLE, PUMPMarketed from Oct 30, 2023 |
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
- Alembic Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215718
- Marketing start
- Listing expires
- Other FDA classes
- Sulfones (Chemical structure)
- Identifiers
- Product ID 62332-663_5fa76202-2367-486b-bfe8-73f3dcd5a574SPL ID 5fa76202-2367-486b-bfe8-73f3dcd5a574SPL set ID 2811f7de-13bf-45cd-8413-5b04d11f40ffRxCUI 1741905UNII 8W5C518302UPC 0362332663309
- 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
N462332066330followed by a unit qualifier and the quantityPackage 62332-0663-30. 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)
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.
Other NDCs under ANDA 215718
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 75 mg/g | GelTopical | Alembic Pharmaceuticals Limited | 46708-663 |