Prescription drug · NDA
Revuforj (Revumenib) NDC 73555-502
Revumenib citrate 160 mg/1 · Tablet, Film coated · Oral · Syndax Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73555-502-00 | 73555050200 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (73555-502-00)Marketed from Nov 15, 2024 |
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)
- Revuforj
- Generic name (nonproprietary)
- revumenib
- Active ingredients
- Revumenib citrate — 160 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Syndax Pharmaceuticals, Inc.NDC labeler code 73555
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 218944
- Marketing start
- Listing expires
- Other FDA classes
- Menin Inhibitors (Mechanism)
- Identifiers
- Product ID 73555-502_76183831-b710-4be2-a6a7-9349dd501830SPL ID 76183831-b710-4be2-a6a7-9349dd501830SPL set ID 6eb3cdbc-0e74-477d-82d6-3bb172d3f63fRxCUI 2698331, 2698337, 2698339, 2698341, 2698343, 2698345UNII YL4RYN734DUPC 0300000000001
- Pharmacologic class
- Menin Inhibitor
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
N473555050200followed by a unit qualifier and the quantityPackage 73555-0502-00. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
REVUFORJ is a menin inhibitor indicated for: the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene ( KMT2A ) translocation as determined by an FDA-authorized test in adult and pediatric patients 1 year and older. ( 1 ) the treatment of relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 ( NPM1 ) mutation in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options. ( 1 ) Relapsed or Refractory Acute Leukemia REVUFORJ is indicated for the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene ( KMT2A ) translocation as determined by an FDA-…
Excerpt only. Read the full label for complete information.
About NDC 73555-502
- What is NDC 73555-502?
- 73555-502 is the product NDC for Revuforj (revumenib), Revumenib citrate 160 mg/1 tablet, film coated, listed with the FDA by Syndax Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Revuforj (Revumenib).
- What is the active ingredient?
- Revumenib citrate.
- Who is the labeler?
- Syndax Pharmaceuticals, Inc., NDC labeler code 73555. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Revuforj?
- 2 other product NDCs are listed under this name. See all Revuforj NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Revuforj products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Revuforjrevumenib | Revumenib citrate 25 mg/1 | Tablet, Film coatedOral | Syndax Pharmaceuticals, Inc. | 73555-500 | 73555-0500-00 |
| Revuforjrevumenib | Revumenib citrate 110 mg/1 | Tablet, Film coatedOral | Syndax Pharmaceuticals, Inc. | 73555-501 | 73555-0501-00 |
Other NDCs under NDA 218944
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Revuforjrevumenib | Revumenib citrate 25 mg/1 | Tablet, Film coatedOral | Syndax Pharmaceuticals, Inc. | 73555-500 |
| Revuforjrevumenib | Revumenib citrate 110 mg/1 | Tablet, Film coatedOral | Syndax Pharmaceuticals, Inc. | 73555-501 |