Prescription drug · NDA
Tabloid (Thioguanine) NDC 80725-630
Thioguanine 40 mg/1 · Tablet · Oral · Waylis Therapeutics LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80725-630-25 | 80725063025 | 1 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
N480725063025followed by a unit qualifier and the quantityPackage 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.
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.