Prescription drug · UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Kodatef (Tafenoquine) NDC 71475-258
Tafenoquine 100 mg/1 · Tablet, Film coated · Oral · 60 Degrees Pharmaceuticals, INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71475-258-03 | 71475025803 | 1 TABLET, FILM COATED in 1 CARTON (71475-258-03)Marketed from Feb 20, 2025 |
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)
- Kodatef
- Generic name (nonproprietary)
- tafenoquine
- Active ingredients
- Tafenoquine — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- 60 Degrees Pharmaceuticals, INCNDC labeler code 71475
- Product type
- Prescription drug
- Marketing category
- Unapproved drug for use in drug shortage
- Marketing start
- Marketing end
- Identifiers
- Product ID 71475-258_2dd1af4c-76f8-d933-e063-6394a90a3931SPL ID 2dd1af4c-76f8-d933-e063-6394a90a3931SPL set ID 2d808b36-5e84-2825-e063-6394a90a3f9fRxCUI 2054096, 2705375UNII 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
N471475025803followed by a unit qualifier and the quantityPackage 71475-0258-03. 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)
Malaria prophylaxis, consistent with the approved use of ARAKODA
Excerpt only. Read the full label for complete information.
About NDC 71475-258
- What is NDC 71475-258?
- 71475-258 is the product NDC for Kodatef (tafenoquine), Tafenoquine 100 mg/1 tablet, film coated, listed with the FDA by 60 Degrees Pharmaceuticals, INC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Kodatef (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 Kodatef?
- 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.