augtyro

Generic: repotrectinib

Labeler: e.r. squibb & sons, l.l.c.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name augtyro
Generic Name repotrectinib
Labeler e.r. squibb & sons, l.l.c.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

repotrectinib 160 mg/1

Manufacturer
E.R. Squibb & Sons, L.L.C.

Identifiers & Regulatory

Product NDC 0003-4160
Product ID 0003-4160_03987a7d-5ac9-4c41-9a48-c9aee4dd13de
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA218213
Listing Expiration 2026-12-31
Marketing Start 2024-11-01

Pharmacologic Class

Established (EPC)
kinase inhibitor [epc]
Mechanism of Action
proto-oncogene tyrosine-protein kinase ros1 inhibitors [moa] tropomyosin receptor tyrosine kinase a inhibitors [moa] tropomyosin receptor tyrosine kinase b inhibitors [moa] tropomyosin receptor tyrosine kinase c inhibitors [moa] cytochrome p450 3a4 inducers [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00034160
Hyphenated Format 0003-4160

Supplemental Identifiers

RxCUI
2670649 2670655 2696876 2696878
UPC
0300000000001
UNII
08O3FQ4UNP
NUI
N0000175605 N0000194093 N0000194094 N0000194095 N0000194096 N0000185506

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name augtyro (source: ndc)
Generic Name repotrectinib (source: ndc)
Application Number NDA218213 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 160 mg/1
source: ndc
Packaging
  • 14 CAPSULE in 1 BOTTLE (0003-4160-14)
  • 60 CAPSULE in 1 BOTTLE (0003-4160-60)
source: ndc

Packages (2)

0003-4160-14 14 CAPSULE in 1 BOTTLE (0003-4160-14) 0003-4160-60 60 CAPSULE in 1 BOTTLE (0003-4160-60)

Ingredients (1)

repotrectinib (160 mg/1)

Linked Drug Pages (1)

Augtyro ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "03987a7d-5ac9-4c41-9a48-c9aee4dd13de", "openfda": {"nui": ["N0000175605", "N0000194093", "N0000194094", "N0000194095", "N0000194096", "N0000185506"], "upc": ["0300000000001"], "unii": ["08O3FQ4UNP"], "rxcui": ["2670649", "2670655", "2696876", "2696878"], "spl_set_id": ["fb526827-40ba-4462-94cf-179ae3b0cb8a"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Proto-Oncogene Tyrosine-Protein Kinase ROS1 Inhibitors [MoA]", "Tropomyosin Receptor Tyrosine Kinase A Inhibitors [MoA]", "Tropomyosin Receptor Tyrosine Kinase B Inhibitors [MoA]", "Tropomyosin Receptor Tyrosine Kinase C Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]"], "manufacturer_name": ["E.R. Squibb & Sons, L.L.C."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "14 CAPSULE in 1 BOTTLE (0003-4160-14)", "package_ndc": "0003-4160-14", "marketing_start_date": "20241101"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (0003-4160-60)", "package_ndc": "0003-4160-60", "marketing_start_date": "20241101"}], "brand_name": "Augtyro", "product_id": "0003-4160_03987a7d-5ac9-4c41-9a48-c9aee4dd13de", "dosage_form": "CAPSULE", "pharm_class": ["Cytochrome P450 3A4 Inducers [MoA]", "Kinase Inhibitor [EPC]", "Proto-Oncogene Tyrosine-Protein Kinase ROS1 Inhibitors [MoA]", "Tropomyosin Receptor Tyrosine Kinase A Inhibitors [MoA]", "Tropomyosin Receptor Tyrosine Kinase B Inhibitors [MoA]", "Tropomyosin Receptor Tyrosine Kinase C Inhibitors [MoA]"], "product_ndc": "0003-4160", "generic_name": "repotrectinib", "labeler_name": "E.R. Squibb & Sons, L.L.C.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Augtyro", "active_ingredients": [{"name": "REPOTRECTINIB", "strength": "160 mg/1"}], "application_number": "NDA218213", "marketing_category": "NDA", "marketing_start_date": "20241101", "listing_expiration_date": "20261231"}