Prescription drug · ANDA
Dapsone 100mg NDC 85185-105
Dapsone 100 mg/1 · Tablet · Oral · Solis Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85185-105-01 | 8518501050185185010501 | 30 TABLET in 1 BOTTLE (85185-105-01)Marketed from May 9, 2016 | |
| 85185-105-02 | 8518501050285185010502 | 100 TABLET in 1 BOTTLE (85185-105-02)Marketed from May 9, 2016 |
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 100mg
- Generic name (nonproprietary)
- dapsone 100mg
- Active ingredients
- Dapsone — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Solis Pharmaceuticals Inc.NDC labeler code 85185
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203887
- Marketing start
- Listing expires
- Other FDA classes
- Sulfones (Chemical structure)
- Identifiers
- Product ID 85185-105_50209cd1-afc6-53f4-e063-6394a90af9cfSPL ID 50209cd1-afc6-53f4-e063-6394a90af9cfSPL set ID 50204029-4c29-5b8d-e063-6394a90af383RxCUI 197557, 197558UNII 8W5C518302UPC 0385185105024
- 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
N485185010501followed by a unit qualifier and the quantityPackage 85185-0105-01. 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)
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 85185-105
- What is NDC 85185-105?
- 85185-105 is the product NDC for Dapsone 100mg, Dapsone 100 mg/1 tablet, listed with the FDA by Solis Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dapsone 100mg.
- What is the active ingredient?
- Dapsone.
- Who is the labeler?
- Solis Pharmaceuticals Inc., NDC labeler code 85185. 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 100mg?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 203887
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 25mg | Dapsone 25 mg/1 | TabletOral | Solis Pharmaceuticals Inc. | 85185-104 |