Prescription drug · NDA
Arakoda (Tafenoquine) NDC 71475-257
Tafenoquine 100 mg/1 · Tablet, Film coated · Oral · 60 Degrees Pharmaceuticals, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71475-257-01 | 71475025701 | 2 BLISTER PACK in 1 CARTON (71475-257-01) / 8 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Aug 20, 2018 | |
| 71475-257-02 | 71475025702 | 8 TABLET, FILM COATED in 1 BOTTLE (71475-257-02)Marketed from Aug 20, 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)
- Arakoda
- Generic name (nonproprietary)
- tafenoquine
- Active ingredients
- Tafenoquine — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- 60 Degrees Pharmaceuticals, INC.NDC labeler code 71475
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 210607
- Marketing start
- Listing expires
- Identifiers
- Product ID 71475-257_661ad23b-4c46-4122-9f6c-06feeb80d95aSPL ID 661ad23b-4c46-4122-9f6c-06feeb80d95aSPL set ID 299e49d8-470f-4779-a010-4a1ee0e0c6cdRxCUI 2054096, 2054102UNII 262P8GS9L9
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
N471475025701followed by a unit qualifier and the quantityPackage 71475-0257-01. 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)
ARAKODA is indicated for the prophylaxis of malaria in patients aged 18 years and older. ARAKODA is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years and older. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 71475-257
- What is NDC 71475-257?
- 71475-257 is the product NDC for Arakoda (tafenoquine), Tafenoquine 100 mg/1 tablet, film coated, listed with the FDA by 60 Degrees Pharmaceuticals, INC.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Arakoda (Tafenoquine).
- What is the active ingredient?
- Tafenoquine.
- Who is the labeler?
- 60 Degrees Pharmaceuticals, INC., NDC labeler code 71475. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Arakoda?
- 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.