FDA.reportPublic FDA data

Augtyro

Product NDC
0003-4160
11-digit product format
000034160
Labeler code
0003
Product ID
0003-4160_03987a7d-5ac9-4c41-9a48-c9aee4dd13de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
repotrectinib
Dosage form
CAPSULE
Route
ORAL
Labeler
E.R. Squibb & Sons, L.L.C.
Application
NDA218213
Marketing category
NDA
Marketing start
2024-11-01
Substance
REPOTRECTINIB
Active strength
160 mg/1
Pharmacologic classes
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]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Augtyro
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
REPOTRECTINIB160 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii08O3FQ4UNP
Rxcui2670649, 2670655, 2696876, 2696878

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f13a3171-d186-4c7b-82a2-952d74f19b40Product name120250225

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0003-4160-14Augtyro14 in 1 BOTTLECAPSULE145
0003-4160-60Augtyro60 in 1 BOTTLECAPSULE605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0003-4160-14EA - Each0003-41608e18ca3f-3631-473b-94b5-c4ea4002017412024-12-10
0003-4160-60EA - Each0003-416051e3be8c-cb92-486f-898b-3f2c3f87a46212024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0003-4160AUGTYRO (REPOTRECTINIB) CAPSULE [E.R. SQUIBB & SONS, L.L.C.]5Current NDC, 2 package rows20241206_fb526827-40ba-4462-94cf-179ae3b0cb8a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2696878Augtyro 160 MG Oral CapsulePSNfb526827-40ba-4462-94cf-179ae3b0cb8a5
2670655AUGTYRO 40 MG Oral CapsulePSNfb526827-40ba-4462-94cf-179ae3b0cb8a5
2696876repotrectinib 160 MG Oral CapsulePSNfb526827-40ba-4462-94cf-179ae3b0cb8a5
2670649repotrectinib 40 MG Oral CapsulePSNfb526827-40ba-4462-94cf-179ae3b0cb8a5
2696878repotrectinib 160 MG Oral Capsule [Augtyro]SBDfb526827-40ba-4462-94cf-179ae3b0cb8a5
2670655repotrectinib 40 MG Oral Capsule [Augtyro]SBDfb526827-40ba-4462-94cf-179ae3b0cb8a5
2696876repotrectinib 160 MG Oral CapsuleSCDfb526827-40ba-4462-94cf-179ae3b0cb8a5
2670649repotrectinib 40 MG Oral CapsuleSCDfb526827-40ba-4462-94cf-179ae3b0cb8a5
2696878Augtyro 160 MG Oral CapsuleSYfb526827-40ba-4462-94cf-179ae3b0cb8a5
2670655Augtyro 40 MG Oral CapsuleSYfb526827-40ba-4462-94cf-179ae3b0cb8a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0003-4160-140000341601414 CAPSULE in 1 BOTTLE (0003-4160-14) 14 capsule2024-11-01NoNoHistorical
0003-4160-600000341606060 CAPSULE in 1 BOTTLE (0003-4160-60) 60 capsule2024-11-01NoNoHistorical