NDC codes

FDA NDC Directory
Product NDC (as listed)80725-630Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80725-0630Add 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
80725-630-25807250630251 BOTTLE in 1 CARTON (80725-630-25) / 25 TABLET in 1 BOTTLEMarketed from May 15, 2023

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)
Tabloid
Generic name (nonproprietary)
thioguanine
Active ingredients
Thioguanine — 40 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Waylis Therapeutics LLCNDC labeler code 80725
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 012429
Marketing start
Listing expires
Identifiers
Product ID 80725-630_120a3a37-e84a-406b-94f8-243897706dc6SPL ID 120a3a37-e84a-406b-94f8-243897706dc6SPL set ID 44b0c461-47fb-4106-ba11-6ed85530235cRxCUI 105590, 198269UNII FTK8U1GZNX
Pharmacologic class
Antimetabolite

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

N480725063025 followed by a unit qualifier and the quantity

Package 80725-0630-25. 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)

INDICATIONS AND USAGE a) Acute Nonlymphocytic Leukemias TABLOID brand Thioguanine is indicated for remission induction and remission consolidation treatment of acute nonlymphocytic leukemias. However, it is not recommended for use during maintenance therapy or similar long-term continuous treatments due to the high risk of liver toxicity (see WARNINGS and ADVERSE REACTIONS). The response to this agent depends upon the age of the patient (younger patients faring better than older) and whether thioguanine is used in previously treated or previously untreated patients. Reliance upon thioguanine alone is seldom justified for initial remission induction of acute nonlymphocytic leukemias because c…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80725-630

What is NDC 80725-630?
80725-630 is the product NDC for Tabloid (thioguanine), Thioguanine 40 mg/1 tablet, listed with the FDA by Waylis Therapeutics LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Tabloid (Thioguanine).
What is the active ingredient?
Thioguanine.
Who is the labeler?
Waylis Therapeutics LLC, NDC labeler code 80725. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tabloid?
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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