Prescription drug · ANDA
Dapsone NDC 51672-1387
Dapsone 50 mg/g · Gel · Topical · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51672-1387-2 | 51672138702 | 1 TUBE in 1 CARTON (51672-1387-2) / 30 g in 1 TUBEMarketed from Oct 16, 2017 | |
| 51672-1387-3 | 51672138703 | 1 TUBE in 1 CARTON (51672-1387-3) / 60 g in 1 TUBEMarketed from Oct 16, 2017 | |
| 51672-1387-8 | 51672138708 | 1 TUBE in 1 CARTON (51672-1387-8) / 90 g in 1 TUBEMarketed from Oct 16, 2017 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 50 mg/g
- Dosage form
- Gel
- Route
- Topical
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209506
- Marketing start
- Listing expires
- Other FDA classes
- Sulfones (Chemical structure)
- Identifiers
- Product ID 51672-1387_38e593e2-d4a5-b8dd-e063-6394a90a62c6SPL ID 38e593e2-d4a5-b8dd-e063-6394a90a62c6SPL set ID 97e6444c-1496-4508-9434-8a2a93225e17RxCUI 607295UNII 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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N451672138702followed by a unit qualifier and the quantityPackage 51672-1387-02. 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, 5%, is indicated for the topical treatment of acne vulgaris. Dapsone gel is indicated for the topical treatment of acne vulgaris ( 1 ).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209506
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 50 mg/g | GelTopical | NORTHSTAR RX LLC | 16714-956 |