Augtyro (repotrectinib) NDC 0003-4160

NDC codes

FDA NDC Directory

Product NDC (as listed)0003-4160Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00003-4160Add 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
0003-4160-14	00003416014	14 CAPSULE in 1 BOTTLE (0003-4160-14)Marketed from Nov 1, 2024
0003-4160-60	00003416060	60 CAPSULE in 1 BOTTLE (0003-4160-60)Marketed from Nov 1, 2024

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): Augtyro
Generic name (nonproprietary): repotrectinib
Active ingredients: Repotrectinib — 160 mg/1
Dosage form: Capsule
Route: Oral
Labeler: E.R. Squibb & Sons, L.L.C.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 218213
Marketing start: Nov 1, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Cytochrome P450 3A4 Inducers (Mechanism)Proto-Oncogene Tyrosine-Protein Kinase ROS1 Inhibitors (Mechanism)Tropomyosin Receptor Tyrosine Kinase A Inhibitors (Mechanism)Tropomyosin Receptor Tyrosine Kinase B Inhibitors (Mechanism)Tropomyosin Receptor Tyrosine Kinase C Inhibitors (Mechanism)
Identifiers: Product ID 0003-4160_9fa5a47f-24bf-464a-aed7-54ad81abf121SPL ID 9fa5a47f-24bf-464a-aed7-54ad81abf121SPL set ID fb526827-40ba-4462-94cf-179ae3b0cb8aRxCUI 2670649, 2670655, 2696876, 2696878UNII 08O3FQ4UNPUPC 0300000000001
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

N400003416014 followed by a unit qualifier and the quantity

Package 00003-4160-14. 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 Jun 13, 2024.

Indications (excerpt from the label)

AUGTYRO is a kinase inhibitor indicated for the treatment of • adult patients with locally advanced or metastatic ROS1- positive non-small cell lung cancer (NSCLC). ( 1.1 ) • adult and pediatric patients 12 years of age and older with solid tumors that: • have a neurotrophic tyrosine receptor kinase ( NTRK ) gene fusion and • are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity. • have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verificatio…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 218213

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 218213
Product	Strength	Form · route	Labeler	Product NDC
Augtyrorepotrectinib	Repotrectinib 40 mg/1	CapsuleOral	E.R. Squibb & Sons, L.L.C.	0003-4040