What is NDC 84651-200?

84651-200 is the product NDC for Ibtrozi (taletrectinib), Taletrectinib adipate 272 mg/1 capsule, listed with the FDA by Nuvation Bio Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Nuvation Bio Inc., NDC labeler code 84651. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Ibtrozi?

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.

Ibtrozi NDC 84651-200 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)84651-200Labeler and product segments. Claims need a package NDC.

Product NDC at billing width84651-0200Add 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 NDC	11-digit (billing)	Package	Copy
84651-200-90	84651020090	1 BOTTLE in 1 CARTON (84651-200-90) / 90 CAPSULE in 1 BOTTLEMarketed from Sep 1, 2026
84651-200-93	84651020093	3 BOTTLE in 1 CARTON (84651-200-93) / 30 CAPSULE in 1 BOTTLE (84651-200-30)Marketed from Jun 13, 2025

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): Ibtrozi
Generic name (nonproprietary): taletrectinib
Active ingredients: Taletrectinib adipate — 272 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Nuvation Bio Inc.NDC labeler code 84651
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 219713
Marketing start: Jun 11, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Proto-Oncogene Tyrosine-Protein Kinase ROS1 Inhibitors (Mechanism)
Identifiers: Product ID 84651-200_12274fa4-44f0-4e87-9683-67b1515ea180SPL ID 12274fa4-44f0-4e87-9683-67b1515ea180
Pharmacologic class: Kinase 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

N484651020090 followed by a unit qualifier and the quantity

Package 84651-0200-90. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 84651-200

What is NDC 84651-200?: 84651-200 is the product NDC for Ibtrozi (taletrectinib), Taletrectinib adipate 272 mg/1 capsule, listed with the FDA by Nuvation Bio Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Ibtrozi (Taletrectinib).
What is the active ingredient?: Taletrectinib adipate.
Who is the labeler?: Nuvation Bio Inc., NDC labeler code 84651. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ibtrozi?: 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.

Ibtrozi (Taletrectinib) NDC 84651-200