Prescription drug · ANDA
Dapsone NDC 70954-136
Dapsone 100 mg/1 · Tablet · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70954-136-10 | 7095401361070954013610 | 30 TABLET in 1 BOTTLE (70954-136-10)Marketed from Jan 15, 2018 | |
| 70954-136-20 | 7095401362070954013620 | 100 TABLET in 1 BOTTLE (70954-136-20)Marketed from Jan 15, 2018 |
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 — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.NDC labeler code 70954
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206505
- Marketing start
- Listing expires
- Other FDA classes
- Sulfones (Chemical structure)
- Identifiers
- Product ID 70954-136_846ff8b6-d395-4e67-98ea-9dbfd688b97eSPL ID 846ff8b6-d395-4e67-98ea-9dbfd688b97eSPL set ID 57a47368-d1f6-4d61-a2ee-c5f1fe7ff690RxCUI 197557, 197558UNII 8W5C518302UPC 0370954135104, 0370954136200, 0370954135203, 0370954136101
- 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
N470954013610followed by a unit qualifier and the quantityPackage 70954-0136-10. 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 .
About NDC 70954-136
- What is NDC 70954-136?
- 70954-136 is the product NDC for Dapsone, Dapsone 100 mg/1 tablet, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dapsone.
- What is the active ingredient?
- Dapsone.
- Who is the labeler?
- ANI Pharmaceuticals, Inc., NDC labeler code 70954. 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 206505
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 25 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-135 |