Prescription drug · ANDA
Dapsone (Dapsone gel, 5%) NDC 21922-018
Dapsone 50 mg/g · Gel · Topical · Encube Ethicals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 21922-018-07 | 2192200180721922001807 | 1 TUBE in 1 CARTON (21922-018-07) / 60 g in 1 TUBEMarketed from Oct 16, 2023 | |
| 21922-018-08 | 2192200180821922001808 | 1 TUBE in 1 CARTON (21922-018-08) / 90 g in 1 TUBEMarketed from Oct 16, 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 gel, 5%
- Active ingredients
- Dapsone — 50 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Encube Ethicals, Inc.NDC labeler code 21922
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212383
- Marketing start
- Listing expires
- Other FDA classes
- Sulfones (Chemical structure)
- Identifiers
- Product ID 21922-018_4805ec1d-1a52-438d-8601-2878f5f40e08SPL ID 4805ec1d-1a52-438d-8601-2878f5f40e08SPL set ID 4205a1a9-c459-47bb-9538-1dd559ca71f1RxCUI 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
N421922001807followed by a unit qualifier and the quantityPackage 21922-0018-07. 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.
Excerpt only. Read the full label for complete information.
About NDC 21922-018
- What is NDC 21922-018?
- 21922-018 is the product NDC for Dapsone, Dapsone 50 mg/g gel, listed with the FDA by Encube Ethicals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dapsone (Dapsone Gel, 5%).
- What is the active ingredient?
- Dapsone.
- Who is the labeler?
- Encube Ethicals, Inc., NDC labeler code 21922. 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 212383
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 | Mayne Pharma | 51862-123 |