Prescription drug · NDA
Krintafel (tafenoquine succinate) NDC 0173-0889
Tafenoquine succinate 150 mg/1 · Tablet, Film coated · Oral · GlaxoSmithKline LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0173-0889-39 | 00173088939 | 2 TABLET, FILM COATED in 1 BOTTLE (0173-0889-39)Marketed from Jan 22, 2019 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Krintafel
- Generic name (nonproprietary)
- tafenoquine succinate
- Active ingredients
- Tafenoquine succinate — 150 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- GlaxoSmithKline LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 210795
- Marketing start
- Listing expires
- Identifiers
- Product ID 0173-0889_d400b994-abe7-40a6-a7bd-0fbf45f855adSPL ID d400b994-abe7-40a6-a7bd-0fbf45f855adSPL set ID 5cf989d5-36f5-4561-a30b-9fcb9deb6b6aRxCUI 2109233, 2109239UNII DL5J0B8VSSUPC 0301730889393
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
N400173088939followed by a unit qualifier and the quantityPackage 00173-0889-39. 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)
KRINTAFEL is indicated for the radical cure (prevention of relapse) of Plasmodium vivax malaria in patients aged 16 years and older who are receiving chloroquine therapy for acute P. vivax infection [see Dosage and Administration ( 2.2 )] . Limitations of Use • KRINTAFEL is NOT indicated for the treatment of acute P. vivax malaria. • Concomitant use of KRINTAFEL with antimalarials other than chloroquine is not recommended because of the risk of recurrence of P. vivax malaria [see Warnings and Precautions ( 5.6 )] . KRINTAFEL is an antimalarial indicated for the radical cure (prevention of relapse) of Plasmodium vivax malaria in patients aged 16 years and older who are receiving chloroquine t…
Excerpt only. Read the full label for complete information.
- openFDA data updated
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