NDC codes

FDA NDC Directory
Product NDC (as listed)71475-257Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71475-0257Add 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
71475-257-01714750257012 BLISTER PACK in 1 CARTON (71475-257-01) / 8 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Aug 20, 2018
71475-257-02714750257028 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

N471475025701 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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