NDC codes

FDA NDC Directory
Product NDC (as listed)71475-258Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71475-0258Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
71475-258-03714750258031 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

N471475025803 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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