Home NDC 0003-4040-12 Augtyro
Product NDC 0003-4040
Requested package NDC 0003-4040-12
11-digit product format 000034040
Labeler code 0003
Product ID 0003-4040_9fa5a47f-24bf-464a-aed7-54ad81abf121
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 2023-12-05
Substance REPOTRECTINIB
Active strength 40 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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N218213-001 AUGTYRO REPOTRECTINIB 40MG CAPSULE / ORAL RLD, RS 2023-11-15 N218213-002 AUGTYRO REPOTRECTINIB 160MG CAPSULE / ORAL RLD, RS 2024-06-11
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N218213-001 RE50634 2035-01-23 Drug substance, Drug product 2025-11-12 N218213-001 10294242 2036-07-05 Drug substance 2023-12-12 N218213-001 12187739 2036-07-05 Drug product 2025-02-21 N218213-001 12310968 2036-07-20 U-3755 2025-06-25 N218213-001 11452725 2036-07-24 U-3755 2023-12-12 N218213-001 11452725 2036-07-24 U-3961 2023-12-12 N218213-002 RE50634 2035-01-23 Drug substance, Drug product 2025-11-12 N218213-002 10294242 2036-07-05 Drug substance 2024-07-10 N218213-002 12187739 2036-07-05 Drug product 2025-02-21 N218213-002 12310968 2036-07-20 U-3755 2025-06-25 N218213-002 11452725 2036-07-24 U-3755 2024-07-10 N218213-002 11452725 2036-07-24 U-3961 2024-07-10
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 6 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218213-002 AUGTYRO 160MG CAPSULE / ORAL RLD, RS 2024-06-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218213-002 AUGTYRO 160MG CAPSULE / ORAL RLD, RS 2024-06-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218213-002 AUGTYRO 160MG CAPSULE / ORAL RLD, RS 2024-06-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218213-002 AUGTYRO 160MG CAPSULE / ORAL RLD, RS 2024-06-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218213-002 AUGTYRO 160MG CAPSULE / ORAL RLD, RS 2024-06-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218213-002 AUGTYRO 160MG CAPSULE / ORAL RLD 2024-06-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218213-002 AUGTYRO 160MG CAPSULE / ORAL RLD 2024-06-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218213-002 AUGTYRO 160MG CAPSULE / ORAL RLD 2024-06-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218213-002 AUGTYRO 160MG CAPSULE / ORAL RLD 2024-06-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218213-002 AUGTYRO 160MG CAPSULE / ORAL RLD 2024-06-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218213-002 AUGTYRO 160MG CAPSULE / ORAL RLD 2024-06-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N218213-002 AUGTYRO 160MG CAPSULE / ORAL RLD 2024-06-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N218213-002 AUGTYRO 160MG CAPSULE / ORAL RLD 2024-06-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 ea1830bbd6c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218213-002 AUGTYRO 160MG CAPSULE / ORAL RLD, RS 2024-06-11 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 4 · 158 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N218213-001 RE50634 2035-01-23 Drug substance, Drug product 2025-11-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218213-001 10294242 2036-07-05 Drug substance 2023-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218213-001 12187739 2036-07-05 Drug product 2025-02-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218213-001 12310968 2036-07-20 U-3755 2025-06-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218213-001 11452725 2036-07-24 U-3961 2023-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218213-001 11452725 2036-07-24 U-3755 2023-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218213-002 RE50634 2035-01-23 Drug substance, Drug product 2025-11-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218213-002 10294242 2036-07-05 Drug substance 2024-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218213-002 12187739 2036-07-05 Drug product 2025-02-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218213-002 12310968 2036-07-20 U-3755 2025-06-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218213-002 11452725 2036-07-24 U-3755 2024-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218213-002 11452725 2036-07-24 U-3961 2024-07-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218213-001 RE50634 2035-01-23 Drug substance, Drug product 2025-11-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218213-001 10294242 2036-07-05 Drug substance 2023-12-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218213-001 12187739 2036-07-05 Drug product 2025-02-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218213-001 12310968 2036-07-20 U-3755 2025-06-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218213-001 11452725 2036-07-24 U-3961 2023-12-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218213-001 11452725 2036-07-24 U-3755 2023-12-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218213-002 RE50634 2035-01-23 Drug substance, Drug product 2025-11-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218213-002 10294242 2036-07-05 Drug substance 2024-07-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218213-002 12187739 2036-07-05 Drug product 2025-02-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218213-002 12310968 2036-07-20 U-3755 2025-06-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218213-002 11452725 2036-07-24 U-3755 2024-07-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218213-002 11452725 2036-07-24 U-3961 2024-07-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218213-001 RE50634 2035-01-23 Drug substance, Drug product 2025-11-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218213-001 10294242 2036-07-05 Drug substance 2023-12-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218213-001 12187739 2036-07-05 Drug product 2025-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218213-001 12310968 2036-07-20 U-3755 2025-06-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218213-001 11452725 2036-07-24 U-3961 2023-12-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218213-001 11452725 2036-07-24 U-3755 2023-12-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218213-002 RE50634 2035-01-23 Drug substance, Drug product 2025-11-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218213-002 10294242 2036-07-05 Drug substance 2024-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218213-002 12187739 2036-07-05 Drug product 2025-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218213-002 12310968 2036-07-20 U-3755 2025-06-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218213-002 11452725 2036-07-24 U-3755 2024-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218213-002 11452725 2036-07-24 U-3961 2024-07-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218213-001 RE50634 2035-01-23 Drug substance, Drug product 2025-11-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218213-001 10294242 2036-07-05 Drug substance 2023-12-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218213-001 12187739 2036-07-05 Drug product 2025-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218213-001 12310968 2036-07-20 U-3755 2025-06-25 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 99 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Augtyro
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength REPOTRECTINIB 40 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 08O3FQ4UNP Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2670649 Internal RxNorm lookup 2670655 Internal RxNorm lookup 2696876 Internal RxNorm lookup 2696878 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0003-4040-12 Augtyro 120 in 1 BOTTLE CAPSULE 120 5 0003-4040-60 Augtyro 60 in 1 BOTTLE CAPSULE 60 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0003-4040 AUGTYRO (REPOTRECTINIB) CAPSULE [E.R. SQUIBB & SONS, L.L.C.] 5 Current NDC, 2 package rows 20241206_fb526827-40ba-4462-94cf-179ae3b0cb8a.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0003-4040-12 00003404012 120 CAPSULE in 1 BOTTLE (0003-4040-12) 120 capsule 2023-12-05 No No Current