JAYPIRCA

Product NDC: 0002-6902
Requested package NDC: 0002-6902-30
11-digit product format: 000026902
Labeler code: 0002
Product ID: 0002-6902_ef421dc8-11db-4e6c-9154-dc04782cb52c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: pirtobrutinib
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Eli Lilly and Company
Application: NDA216059
Marketing category: NDA
Marketing start: 2023-01-27
Substance: PIRTOBRUTINIB
Active strength: 50 mg/1
Pharmacologic classes: Breast Cancer Resistance Protein Inhibitors [MoA], Bruton's Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein 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
N216059-001	JAYPIRCA	PIRTOBRUTINIB	50MG	TABLET / ORAL		RLD	2023-01-27
N216059-002	JAYPIRCA	PIRTOBRUTINIB	100MG	TABLET / ORAL		RLD, RS	2023-01-27

Orange Book patents#

Current patent rows page 1 of 1 · 22 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N216059-001	10342780	2036-12-16		Drug substance, Drug product	2023-02-10
N216059-001	10464905	2036-12-16	U-3518		2023-02-10
N216059-001	10464905	2036-12-16	U-4362		2023-02-10
N216059-001	10695323	2036-12-16	U-3518	Drug substance, Drug product	2023-02-10
N216059-001	10695323	2036-12-16	U-4362	Drug substance, Drug product	2023-02-10
N216059-001	10918622	2036-12-16	U-3518		2023-02-10
N216059-001	10918622	2036-12-16	U-4362		2023-02-10
N216059-001	12220401	2036-12-16	U-3518	Drug substance, Drug product	2025-03-05
N216059-001	12220401	2036-12-16	U-4362	Drug substance, Drug product	2025-03-05
N216059-001	12268666	2039-07-29		Drug product	2025-05-06
N216059-001	12109193	2041-09-14		Drug product	2024-10-31
N216059-002	10342780	2036-12-16		Drug substance, Drug product	2023-02-10
N216059-002	10464905	2036-12-16	U-3518		2023-02-10
N216059-002	10464905	2036-12-16	U-4362		2023-02-10
N216059-002	10695323	2036-12-16	U-3518	Drug substance, Drug product	2023-02-10
N216059-002	10695323	2036-12-16	U-4362	Drug substance, Drug product	2023-02-10
N216059-002	10918622	2036-12-16	U-3518		2023-02-10
N216059-002	10918622	2036-12-16	U-4362		2023-02-10
N216059-002	12220401	2036-12-16	U-3518	Drug substance, Drug product	2025-03-05
N216059-002	12220401	2036-12-16	U-4362	Drug substance, Drug product	2025-03-05
N216059-002	12268666	2039-07-29		Drug product	2025-05-06
N216059-002	12109193	2041-09-14		Drug product	2024-10-31

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 10 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N216059-001	NCE	2028-01-27
N216059-001	I-981	2028-12-02
N216059-001	ODE-424	2030-01-27
N216059-001	ODE-451	2030-12-01
N216059-001	ODE-518	2032-12-03
N216059-002	NCE	2028-01-27
N216059-002	I-981	2028-12-02
N216059-002	ODE-424	2030-01-27
N216059-002	ODE-451	2030-12-01
N216059-002	ODE-518	2032-12-03

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.

Product history page 1 of 2 · 50 observed 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	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`a72a2bbeb626…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 376 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	N216059-001	10342780	2036-12-16		Drug substance, Drug product	2023-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-001	10464905	2036-12-16	U-3518		2023-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-001	10464905	2036-12-16	U-4362		2023-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-001	10695323	2036-12-16	U-3518	Drug substance, Drug product	2023-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-001	10695323	2036-12-16	U-4362	Drug substance, Drug product	2023-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-001	10918622	2036-12-16	U-3518		2023-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-001	10918622	2036-12-16	U-4362		2023-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-001	12220401	2036-12-16	U-3518	Drug substance, Drug product	2025-03-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-001	12220401	2036-12-16	U-4362	Drug substance, Drug product	2025-03-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-001	12268666	2039-07-29		Drug product	2025-05-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-001	12109193	2041-09-14		Drug product	2024-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-002	10342780	2036-12-16		Drug substance, Drug product	2023-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-002	10464905	2036-12-16	U-3518		2023-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-002	10464905	2036-12-16	U-4362		2023-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-002	10695323	2036-12-16	U-3518	Drug substance, Drug product	2023-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-002	10695323	2036-12-16	U-4362	Drug substance, Drug product	2023-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-002	10918622	2036-12-16	U-3518		2023-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-002	10918622	2036-12-16	U-4362		2023-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-002	12220401	2036-12-16	U-3518	Drug substance, Drug product	2025-03-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-002	12220401	2036-12-16	U-4362	Drug substance, Drug product	2025-03-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-002	12268666	2039-07-29		Drug product	2025-05-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-002	12109193	2041-09-14		Drug product	2024-10-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216059-001	10342780	2036-12-16		Drug substance, Drug product	2023-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216059-001	10464905	2036-12-16	U-3518		2023-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216059-001	10464905	2036-12-16	U-4362		2023-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216059-001	10695323	2036-12-16	U-3518	Drug substance, Drug product	2023-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216059-001	10695323	2036-12-16	U-4362	Drug substance, Drug product	2023-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216059-001	10918622	2036-12-16	U-3518		2023-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216059-001	10918622	2036-12-16	U-4362		2023-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216059-001	12220401	2036-12-16	U-3518	Drug substance, Drug product	2025-03-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216059-001	12220401	2036-12-16	U-4362	Drug substance, Drug product	2025-03-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216059-001	12268666	2039-07-29		Drug product	2025-05-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216059-001	12109193	2041-09-14		Drug product	2024-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216059-002	10342780	2036-12-16		Drug substance, Drug product	2023-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216059-002	10464905	2036-12-16	U-3518		2023-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216059-002	10464905	2036-12-16	U-4362		2023-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216059-002	10695323	2036-12-16	U-3518	Drug substance, Drug product	2023-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216059-002	10695323	2036-12-16	U-4362	Drug substance, Drug product	2023-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216059-002	10918622	2036-12-16	U-3518		2023-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216059-002	10918622	2036-12-16	U-4362		2023-02-10	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 152 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	N216059-001	NCE	2028-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-001	I-981	2028-12-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-001	ODE-424	2030-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-001	ODE-451	2030-12-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-001	ODE-518	2032-12-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-002	NCE	2028-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-002	I-981	2028-12-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-002	ODE-424	2030-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-002	ODE-451	2030-12-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-002	ODE-518	2032-12-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216059-001	NCE	2028-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216059-001	I-981	2028-12-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216059-001	ODE-424	2030-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216059-001	ODE-451	2030-12-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216059-001	ODE-518	2032-12-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216059-002	NCE	2028-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216059-002	I-981	2028-12-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216059-002	ODE-424	2030-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216059-002	ODE-451	2030-12-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216059-002	ODE-518	2032-12-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216059-001	NCE	2028-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216059-001	I-981	2028-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216059-001	ODE-424	2030-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216059-001	ODE-451	2030-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216059-002	NCE	2028-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216059-002	I-981	2028-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216059-002	ODE-424	2030-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216059-002	ODE-451	2030-12-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216059-001	NCE	2028-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216059-001	ODE-424	2030-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216059-001	ODE-451	2030-12-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216059-002	NCE	2028-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216059-002	ODE-424	2030-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216059-002	ODE-451	2030-12-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216059-001	NCE	2028-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216059-001	ODE-424	2030-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216059-001	ODE-451	2030-12-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216059-002	NCE	2028-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216059-002	ODE-424	2030-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216059-002	ODE-451	2030-12-01	`6a471c1ec25d…`

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: JAYPIRCA
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PIRTOBRUTINIB	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
JNA39I7ZVB	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2629343	Internal RxNorm lookup
2629349	Internal RxNorm lookup
2629351	Internal RxNorm lookup
2629353	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
bd551845-0878-49a4-860f-839b83f6b801	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2428a55d-ee72-4c52-8fe6-5cdd94d2f812	Product name	1	20240223

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0002-6902-30	JAYPIRCA	30 in 1 BOTTLE	TABLET, COATED	30		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0002-6902-30	EA - Each	0002-6902	ac00dc8b-3476-4c17-9f39-394ffddd6f55	1	2023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0002-6902	JAYPIRCA (PIRTOBRUTINIB) TABLET, COATED [ELI LILLY AND COMPANY]	11	Current NDC, 1 package rows	20250321_bd551845-0878-49a4-860f-839b83f6b801.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
JAYPIRCA	PIRTOBRUTINIB	Eli Lilly and Company	bd551845-0878-49a4-860f-839b83f6b801	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 216059 application number: NDA216059 ndc (package): 0002-6902-30 ndc (product): 0002-6902 ndc11 (package): 00002690230

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2629349	Jaypirca 100 MG Oral Tablet	PSN	bd551845-0878-49a4-860f-839b83f6b801	14
2629353	Jaypirca 50 MG Oral Tablet	PSN	bd551845-0878-49a4-860f-839b83f6b801	14
2629343	pirtobrutinib 100 MG Oral Tablet	PSN	bd551845-0878-49a4-860f-839b83f6b801	14
2629351	pirtobrutinib 50 MG Oral Tablet	PSN	bd551845-0878-49a4-860f-839b83f6b801	14
2629349	pirtobrutinib 100 MG Oral Tablet [Jaypirca]	SBD	bd551845-0878-49a4-860f-839b83f6b801	14
2629353	pirtobrutinib 50 MG Oral Tablet [Jaypirca]	SBD	bd551845-0878-49a4-860f-839b83f6b801	14
2629343	pirtobrutinib 100 MG Oral Tablet	SCD	bd551845-0878-49a4-860f-839b83f6b801	14
2629351	pirtobrutinib 50 MG Oral Tablet	SCD	bd551845-0878-49a4-860f-839b83f6b801	14
2629349	Jaypirca 100 MG Oral Tablet	SY	bd551845-0878-49a4-860f-839b83f6b801	14
2629353	Jaypirca 50 MG Oral Tablet	SY	bd551845-0878-49a4-860f-839b83f6b801	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0002-6902-30	00002690230	30 TABLET, COATED in 1 BOTTLE (0002-6902-30)	2023-01-27	No	No	Current