Home NDC 0310-9501 TRUQAP
Product NDC 0310-9501
11-digit product format 003109501
Labeler code 0310
Product ID 0310-9501_35bf673a-53ef-404c-bcdb-08fc92e7e46b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name capivasertib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler AstraZeneca Pharmaceuticals LP
Application NDA218197
Marketing category NDA
Marketing start 2023-11-16
Substance CAPIVASERTIB
Active strength 200 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…
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 N218197-001 TRUQAP CAPIVASERTIB 160MG TABLET / ORAL RLD 2023-11-16 N218197-002 TRUQAP CAPIVASERTIB 200MG TABLET / ORAL RLD, RS 2023-11-16
Orange Book patents# Current patent rows page 1 of 1 · 20 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N218197-001 10059714 2028-10-10 Drug substance, Drug product 2023-12-13 N218197-001 10654855 2028-10-10 U-3762 2023-12-13 N218197-001 11236095 2028-10-10 U-4559 2026-07-07 N218197-001 11760760 2028-10-10 U-3762 2023-12-13 N218197-001 12252495 2028-10-10 U-3762 2025-03-28 N218197-001 9492453 2028-10-10 U-4559 2026-07-07 N218197-001 8101623 2030-03-10 U-3762 Drug substance, Drug product 2023-12-13 N218197-001 10039766 2033-04-16 U-3762 2023-12-13 N218197-001 10039766 2033-04-16 U-4559 2023-12-13 N218197-001 9487525 2033-04-16 Drug substance, Drug product 2023-12-13 N218197-002 10059714 2028-10-10 Drug substance, Drug product 2023-12-13 N218197-002 10654855 2028-10-10 U-3762 2023-12-13 N218197-002 11236095 2028-10-10 U-4559 2026-07-07 N218197-002 11760760 2028-10-10 U-3762 2023-12-13 N218197-002 12252495 2028-10-10 U-3762 2025-03-28 N218197-002 9492453 2028-10-10 U-4559 2026-07-07 N218197-002 8101623 2030-03-10 U-3762 Drug substance, Drug product 2023-12-13 N218197-002 10039766 2033-04-16 U-3762 2023-12-13 N218197-002 10039766 2033-04-16 U-4559 2023-12-13 N218197-002 9487525 2033-04-16 Drug substance, Drug product 2023-12-13
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 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 N218197-001 TRUQAP 160MG TABLET / ORAL RLD 2023-11-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218197-002 TRUQAP 200MG TABLET / ORAL RLD, RS 2023-11-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218197-001 TRUQAP 160MG TABLET / ORAL RLD 2023-11-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218197-002 TRUQAP 200MG TABLET / ORAL RLD, RS 2023-11-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218197-001 TRUQAP 160MG TABLET / ORAL RLD 2023-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218197-002 TRUQAP 200MG TABLET / ORAL RLD, RS 2023-11-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218197-001 TRUQAP 160MG TABLET / ORAL RLD 2023-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218197-002 TRUQAP 200MG TABLET / ORAL RLD, RS 2023-11-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218197-001 TRUQAP 160MG TABLET / ORAL RLD 2023-11-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218197-002 TRUQAP 200MG TABLET / ORAL RLD, RS 2023-11-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218197-001 TRUQAP 160MG TABLET / ORAL RLD 2023-11-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218197-002 TRUQAP 200MG TABLET / ORAL RLD, RS 2023-11-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218197-001 TRUQAP 160MG TABLET / ORAL RLD 2023-11-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218197-002 TRUQAP 200MG TABLET / ORAL RLD, RS 2023-11-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218197-001 TRUQAP 160MG TABLET / ORAL RLD 2023-11-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218197-002 TRUQAP 200MG TABLET / ORAL RLD, RS 2023-11-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218197-001 TRUQAP 160MG TABLET / ORAL RLD 2023-11-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218197-002 TRUQAP 200MG TABLET / ORAL RLD, RS 2023-11-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218197-001 TRUQAP 160MG TABLET / ORAL RLD 2023-11-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218197-002 TRUQAP 200MG TABLET / ORAL RLD, RS 2023-11-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218197-001 TRUQAP 160MG TABLET / ORAL RLD 2023-11-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218197-002 TRUQAP 200MG TABLET / ORAL RLD, RS 2023-11-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N218197-001 TRUQAP 160MG TABLET / ORAL RLD 2023-11-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N218197-002 TRUQAP 200MG TABLET / ORAL RLD, RS 2023-11-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N218197-001 TRUQAP 160MG TABLET / ORAL RLD 2023-11-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N218197-002 TRUQAP 200MG TABLET / ORAL RLD, RS 2023-11-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N218197-001 TRUQAP 160MG TABLET / ORAL RLD 2023-11-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N218197-002 TRUQAP 200MG TABLET / ORAL RLD, RS 2023-11-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N218197-001 TRUQAP 160MG TABLET / ORAL RLD 2023-11-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N218197-002 TRUQAP 200MG TABLET / ORAL RLD, RS 2023-11-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N218197-001 TRUQAP 160MG TABLET / ORAL RLD 2023-11-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N218197-002 TRUQAP 200MG TABLET / ORAL RLD, RS 2023-11-16 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N218197-001 TRUQAP 160MG TABLET / ORAL RLD 2023-11-16 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N218197-002 TRUQAP 200MG TABLET / ORAL RLD, RS 2023-11-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N218197-001 TRUQAP 160MG TABLET / ORAL RLD 2023-11-16 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N218197-002 TRUQAP 200MG TABLET / ORAL RLD, RS 2023-11-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N218197-001 TRUQAP 160MG TABLET / ORAL RLD 2023-11-16 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N218197-002 TRUQAP 200MG TABLET / ORAL RLD, RS 2023-11-16 ea1830bbd6c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218197-001 TRUQAP 160MG TABLET / ORAL RLD 2023-11-16 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218197-002 TRUQAP 200MG TABLET / ORAL RLD, RS 2023-11-16 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 8 · 318 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 N218197-001 10059714 2028-10-10 Drug substance, Drug product 2023-12-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218197-001 10654855 2028-10-10 U-3762 2023-12-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218197-001 11236095 2028-10-10 U-4559 2026-07-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218197-001 11760760 2028-10-10 U-3762 2023-12-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218197-001 12252495 2028-10-10 U-3762 2025-03-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218197-001 9492453 2028-10-10 U-4559 2026-07-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218197-001 8101623 2030-03-10 U-3762 Drug substance, Drug product 2023-12-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218197-001 10039766 2033-04-16 U-3762 2023-12-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218197-001 10039766 2033-04-16 U-4559 2023-12-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218197-001 9487525 2033-04-16 Drug substance, Drug product 2023-12-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218197-002 10059714 2028-10-10 Drug substance, Drug product 2023-12-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218197-002 10654855 2028-10-10 U-3762 2023-12-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218197-002 11236095 2028-10-10 U-4559 2026-07-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218197-002 11760760 2028-10-10 U-3762 2023-12-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218197-002 12252495 2028-10-10 U-3762 2025-03-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218197-002 9492453 2028-10-10 U-4559 2026-07-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218197-002 8101623 2030-03-10 U-3762 Drug substance, Drug product 2023-12-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218197-002 10039766 2033-04-16 U-3762 2023-12-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218197-002 10039766 2033-04-16 U-4559 2023-12-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218197-002 9487525 2033-04-16 Drug substance, Drug product 2023-12-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218197-001 10059714 2028-10-10 Drug substance, Drug product 2023-12-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218197-001 10654855 2028-10-10 U-3762 2023-12-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218197-001 11236095 2028-10-10 U-4559 2026-07-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218197-001 11760760 2028-10-10 U-3762 2023-12-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218197-001 12252495 2028-10-10 U-3762 2025-03-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218197-001 9492453 2028-10-10 U-4559 2026-07-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218197-001 8101623 2030-03-10 U-3762 Drug substance, Drug product 2023-12-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218197-001 10039766 2033-04-16 U-3762 2023-12-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218197-001 10039766 2033-04-16 U-4559 2023-12-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218197-001 9487525 2033-04-16 Drug substance, Drug product 2023-12-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218197-002 10059714 2028-10-10 Drug substance, Drug product 2023-12-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218197-002 10654855 2028-10-10 U-3762 2023-12-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218197-002 11236095 2028-10-10 U-4559 2026-07-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218197-002 11760760 2028-10-10 U-3762 2023-12-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218197-002 12252495 2028-10-10 U-3762 2025-03-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218197-002 9492453 2028-10-10 U-4559 2026-07-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218197-002 8101623 2030-03-10 U-3762 Drug substance, Drug product 2023-12-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218197-002 10039766 2033-04-16 U-3762 2023-12-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218197-002 10039766 2033-04-16 U-4559 2023-12-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218197-002 9487525 2033-04-16 Drug substance, Drug product 2023-12-13 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 44 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 TRUQAP
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CAPIVASERTIB 200 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0310-9501-01 TRUQAP 64 in 1 BOTTLE TABLET, FILM COATED 64 8 0310-9501-02 TRUQAP 16 in 1 BLISTER PACK TABLET, FILM COATED 16 8 0310-9501-02 TRUQAP 4 in 1 CARTON TABLET, FILM COATED 4 8 0310-9501-95 TRUQAP 64 in 1 BOTTLE TABLET, FILM COATED 64 8 0310-9501-96 TRUQAP 4 in 1 CARTON TABLET, FILM COATED 4 8 0310-9501-96 TRUQAP 16 in 1 BLISTER PACK TABLET, FILM COATED 16 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0310-9501 TRUQAP (CAPIVASERTIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 7 Current NDC, 6 package rows 20250226_d698c106-2322-401e-b738-cbd83c843ecf.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0310-9501-01 00310950101 64 TABLET, FILM COATED in 1 BOTTLE (0310-9501-01) 2023-11-16 No No Current 0310-9501-02 00310950102 4 BLISTER PACK in 1 CARTON (0310-9501-02) / 16 TABLET, FILM COATED in 1 BLISTER PACK 4 blister pack 2024-10-18 No No Current 0310-9501-04 00310950104 4 BLISTER PACK in 1 CARTON (0310-9501-04) / 8 TABLET, FILM COATED in 1 BLISTER PACK 4 blister pack 2026-06-03 No No Current 0310-9501-95 00310950195 64 in 1 BOTTLE Historical 0310-9501-96 00310950196 4 BLISTER PACK in 1 CARTON (0310-9501-96) / 16 TABLET, FILM COATED in 1 BLISTER PACK 4 blister pack 2024-10-23 Yes No Current