QINLOCK

Product NDC: 73207-101
11-digit product format: 732070101
Labeler code: 73207
Product ID: 73207-101_142c8672-a552-4d20-9226-2a92aa9773d1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ripretinib
Dosage form: TABLET
Route: ORAL
Labeler: Deciphera Pharmaceuticals, LLC
Application: NDA213973
Marketing category: NDA
Marketing start: 2020-05-15
Substance: RIPRETINIB
Active strength: 50 mg/1
Pharmacologic classes: Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], Platelet-derived Growth Factor alpha Receptor Inhibitors [MoA], Stem Cell Factor (KIT) Receptor Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	73207-101		I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	73207-101	73207-101-31	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	73207-101	73207-101-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N213973-001	QINLOCK	RIPRETINIB	50MG	TABLET / ORAL		RLD, RS	2020-05-15

Orange Book patents#

Current patent rows page 1 of 1 · 42 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213973-001	8188113	2030-07-27		Drug substance, Drug product	2020-06-11
N213973-001	RE48731	2032-06-07	U-3219		2021-10-04
N213973-001	8461179	2034-05-15		Drug substance, Drug product	2020-06-11
N213973-001	10966966	2040-08-12	U-3153		2021-05-03
N213973-001	11266635	2040-08-12	U-3330		2022-03-24
N213973-001	11344536	2040-08-12	U-3381		2022-06-17
N213973-001	11426390	2040-08-12	U-3416		2022-09-15
N213973-001	11433056	2040-08-12	U-3423		2022-09-22
N213973-001	11529336	2040-08-12	U-3382		2023-01-12
N213973-001	11534432	2040-08-12	U-3442		2023-01-12
N213973-001	11576904	2040-08-12	U-3537		2023-03-06
N213973-001	11813251	2040-08-12	U-3750		2023-11-29
N213973-001	12023325	2040-08-12	U-3960		2024-07-03
N213973-001	12023326	2040-08-12	U-3959		2024-07-03
N213973-001	12023327	2040-08-12	U-3958		2024-07-03
N213973-001	12059410	2040-08-12	U-3153		2024-08-13
N213973-001	12059411	2040-08-12	U-3971		2024-08-13
N213973-001	12295944	2040-08-12	U-4183		2025-05-20
N213973-001	12318373	2040-08-12	U-4191		2025-06-10
N213973-001	11185535	2040-12-30		Drug product	2021-12-13
N213973-001	11395818	2040-12-30		Drug product	2022-08-11
N213973-001	11576903	2040-12-30		Drug product	2023-03-06
N213973-001	11612591	2040-12-30		Drug product	2023-04-10
N213973-001	11793795	2040-12-30		Drug product	2023-11-02
N213973-001	11801237	2040-12-30	U-3219	Drug product	2023-11-16
N213973-001	11844788	2040-12-30		Drug product	2024-01-08
N213973-001	11850240	2040-12-30		Drug product	2024-01-08
N213973-001	11850241	2040-12-30		Drug product	2024-01-08
N213973-001	11896585	2040-12-30		Drug product	2024-02-27
N213973-001	11903933	2040-12-30		Drug product	2024-02-27
N213973-001	11911370	2040-12-30		Drug product	2024-03-13
N213973-001	11918564	2040-12-30		Drug product	2024-03-13
N213973-001	11969415	2040-12-30	U-3219		2024-05-08
N213973-001	12023328	2040-12-30	U-3957		2024-07-03
N213973-001	12064422	2040-12-30	U-3219		2024-08-20
N213973-001	12213967	2040-12-30		Drug product	2025-02-07
N213973-001	12213968	2040-12-30		Drug product	2025-02-07
N213973-001	12226406	2040-12-30		Drug product	2025-02-20
N213973-001	12318374	2040-12-30		Drug product	2025-06-10
N213973-001	12708617	2040-12-30	U-3219		2026-08-26
N213973-001	11969414	2041-02-08	U-3897		2024-05-08
N213973-001	11779572	2042-10-06	U-3714		2023-11-02

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N213973-001	ODE-298	2027-05-15

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213973-001	QINLOCK	50MG	TABLET / ORAL	RLD, RS	2020-05-15	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 22 · 842 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	N213973-001	8188113	2030-07-27		Drug substance, Drug product	2020-06-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	RE48731	2032-06-07	U-3219		2021-10-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	8461179	2034-05-15		Drug substance, Drug product	2020-06-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	10966966	2040-08-12	U-3153		2021-05-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	11266635	2040-08-12	U-3330		2022-03-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	11344536	2040-08-12	U-3381		2022-06-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	11426390	2040-08-12	U-3416		2022-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	11433056	2040-08-12	U-3423		2022-09-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	11529336	2040-08-12	U-3382		2023-01-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	11534432	2040-08-12	U-3442		2023-01-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	11576904	2040-08-12	U-3537		2023-03-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	11813251	2040-08-12	U-3750		2023-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	12023325	2040-08-12	U-3960		2024-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	12023326	2040-08-12	U-3959		2024-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	12023327	2040-08-12	U-3958		2024-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	12059410	2040-08-12	U-3153		2024-08-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	12059411	2040-08-12	U-3971		2024-08-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	12295944	2040-08-12	U-4183		2025-05-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	12318373	2040-08-12	U-4191		2025-06-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	11185535	2040-12-30		Drug product	2021-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	11395818	2040-12-30		Drug product	2022-08-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	11576903	2040-12-30		Drug product	2023-03-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	11612591	2040-12-30		Drug product	2023-04-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	11793795	2040-12-30		Drug product	2023-11-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	11801237	2040-12-30	U-3219	Drug product	2023-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	11844788	2040-12-30		Drug product	2024-01-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	11850240	2040-12-30		Drug product	2024-01-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	11850241	2040-12-30		Drug product	2024-01-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	11896585	2040-12-30		Drug product	2024-02-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	11903933	2040-12-30		Drug product	2024-02-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	11911370	2040-12-30		Drug product	2024-03-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	11918564	2040-12-30		Drug product	2024-03-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	11969415	2040-12-30	U-3219		2024-05-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	12023328	2040-12-30	U-3957		2024-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	12064422	2040-12-30	U-3219		2024-08-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	12213967	2040-12-30		Drug product	2025-02-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	12213968	2040-12-30		Drug product	2025-02-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	12226406	2040-12-30		Drug product	2025-02-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	12318374	2040-12-30		Drug product	2025-06-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213973-001	12708617	2040-12-30	U-3219		2026-08-26	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N213973-001	ODE-298	2027-05-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213973-001	ODE-298	2027-05-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213973-001	ODE-298	2027-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213973-001	NCE	2025-05-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213973-001	ODE-298	2027-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213973-001	NCE	2025-05-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213973-001	ODE-298	2027-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213973-001	NCE	2025-05-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213973-001	ODE-298	2027-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213973-001	NCE	2025-05-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213973-001	ODE-298	2027-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213973-001	NCE	2025-05-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213973-001	ODE-298	2027-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213973-001	NCE	2025-05-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213973-001	ODE-298	2027-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213973-001	NCE	2025-05-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213973-001	ODE-298	2027-05-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213973-001	NCE	2025-05-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213973-001	ODE-298	2027-05-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213973-001	NCE	2025-05-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213973-001	ODE-298	2027-05-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213973-001	NCE	2025-05-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213973-001	ODE-298	2027-05-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213973-001	NCE	2025-05-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213973-001	ODE-298	2027-05-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213973-001	NCE	2025-05-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213973-001	ODE-298	2027-05-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213973-001	NCE	2025-05-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N213973-001	ODE-298	2027-05-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213973-001	NCE	2025-05-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213973-001	ODE-298	2027-05-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213973-001	NCE	2025-05-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N213973-001	ODE-298	2027-05-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213973-001	NCE	2025-05-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N213973-001	ODE-298	2027-05-15	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213973-001	NCE	2025-05-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N213973-001	ODE-298	2027-05-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213973-001	NCE	2025-05-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N213973-001	ODE-298	2027-05-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213973-001	NCE	2025-05-15	`87673890dc5c…`

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: QINLOCK
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RIPRETINIB	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9XW757O13D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2369397	Internal RxNorm lookup
2369403	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9f18e462-03dd-4296-a02a-a0577e3ee78d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b5822ce0-4e78-4723-b738-8b73ca6586e4	Product name	1	20201008

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
73207-101-30	2024-11-05	These highlights do not include all the information needed to use QINLOCK safely and effectively. See full prescribing information for QINLOCK. QINLOCK ® (ripretinib) tablets, for oral use Initial U.S. Approval: 2020
73207-101-31	2024-11-05	These highlights do not include all the information needed to use QINLOCK safely and effectively. See full prescribing information for QINLOCK. QINLOCK ® (ripretinib) tablets, for oral use Initial U.S. Approval: 2020
73207-101-30	2024-07-30	These highlights do not include all the information needed to use QINLOCK safely and effectively. See full prescribing information for QINLOCK. QINLOCK ® (ripretinib) tablets, for oral use Initial U.S. Approval: 2020
73207-101-31	2024-07-30	These highlights do not include all the information needed to use QINLOCK safely and effectively. See full prescribing information for QINLOCK. QINLOCK ® (ripretinib) tablets, for oral use Initial U.S. Approval: 2020
73207-101-30	2024-01-30	These highlights do not include all the information needed to use QINLOCK safely and effectively. See full prescribing information for QINLOCK. QINLOCK ® (ripretinib) tablets, for oral use Initial U.S. Approval: 2020
73207-101-31	2024-01-30	These highlights do not include all the information needed to use QINLOCK safely and effectively. See full prescribing information for QINLOCK. QINLOCK ® (ripretinib) tablets, for oral use Initial U.S. Approval: 2020

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
73207-101-30	QINLOCK	90 in 1 BOTTLE	TABLET	90	9
73207-101-30	QINLOCK	1 in 1 CARTON	TABLET	1	9
73207-101-31	QINLOCK	30 in 1 BOTTLE	TABLET	30	9
73207-101-31	QINLOCK	1 in 1 CARTON	TABLET	1	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
73207-101-30	EA - Each	73207-101	dd83984a-1029-4a48-90eb-6628fdf43a30	1	2020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73207-101	QINLOCK (RIPRETINIB) TABLET [DECIPHERA PHARMACEUTICALS, LLC ]	9	Current NDC, Legacy NDC, 4 package rows	20250514_9f18e462-03dd-4296-a02a-a0577e3ee78d.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
QINLOCK	RIPRETINIB	Deciphera Pharmaceuticals, LLC	9f18e462-03dd-4296-a02a-a0577e3ee78d	2025-05-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213973 application number: NDA213973 ndc (product): 73207-101

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9XW757O13D	RIPRETINIB	1442472-39-0	RIPRETINIB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2369403	QINLOCK 50 MG Oral Tablet	PSN	9f18e462-03dd-4296-a02a-a0577e3ee78d	9
2369397	ripretinib 50 MG Oral Tablet	PSN	9f18e462-03dd-4296-a02a-a0577e3ee78d	9
2369403	ripretinib 50 MG Oral Tablet [Qinlock]	SBD	9f18e462-03dd-4296-a02a-a0577e3ee78d	9
2369397	ripretinib 50 MG Oral Tablet	SCD	9f18e462-03dd-4296-a02a-a0577e3ee78d	9
2369403	Qinlock 50 MG Oral Tablet	SY	9f18e462-03dd-4296-a02a-a0577e3ee78d	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
73207-101-30	73207010130	1 BOTTLE in 1 CARTON (73207-101-30) / 90 TABLET in 1 BOTTLE	1 bottle	2020-05-15	0000-00-00	No	No	Current
73207-101-31	73207010131	1 BOTTLE in 1 CARTON (73207-101-31) / 30 TABLET in 1 BOTTLE	1 bottle	2020-05-15	0000-00-00	Yes	No	Current