Prescription drug · ANDA
Dapsone NDC 16714-956
Dapsone 50 mg/g · Gel · Topical · NORTHSTAR RX LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-956-01 | 16714095601 | 1 TUBE in 1 CARTON (16714-956-01) / 60 g in 1 TUBEMarketed from Apr 25, 2019 | |
| 16714-956-02 | 16714095602 | 1 TUBE in 1 CARTON (16714-956-02) / 90 g in 1 TUBEMarketed from Apr 25, 2019 |
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 — 50 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- NORTHSTAR RX LLC
- 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 16714-956_3980a223-560e-186f-e063-6394a90a0d68SPL ID 3980a223-560e-186f-e063-6394a90a0d68SPL set ID 91d027f1-cbc6-4066-870b-01b1ddb1f48fRxCUI 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
N416714095601followed by a unit qualifier and the quantityPackage 16714-0956-01. 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 | Sun Pharmaceutical Industries, Inc. | 51672-1387 |