PYRUKYND

Product NDC: 71334-215
11-digit product format: 713340215
Labeler code: 71334
Product ID: 71334-215_bdb78a70-8e28-47d7-a211-f8841fa17d22
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mitapivat
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Agios Pharmaceuticals, Inc.
Application: NDA216196
Marketing category: NDA
Marketing start: 2022-02-18
Substance: MITAPIVAT
Active strength: 50 mg/1
Pharmacologic classes: Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], P-Glycoprotein Inhibitors [MoA], Pyruvate Kinase Activator [EPC], Pyruvate Kinase Activators [MoA], UGT1A1 Inducers [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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N216196-001	PYRUKYND	MITAPIVAT SULFATE	EQ 5MG BASE	TABLET / ORAL	RLD	2022-02-17
N216196-002	PYRUKYND	MITAPIVAT SULFATE	EQ 20MG BASE	TABLET / ORAL	RLD	2022-02-17
N216196-003	PYRUKYND	MITAPIVAT SULFATE	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-02-17
N216196-004	AQVESME	MITAPIVAT SULFATE	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2025-12-23

Orange Book patents#

Current patent rows page 1 of 1 · 33 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N216196-001	10632114	2032-05-03	U-3320		2022-03-08
N216196-001	9682080	2032-05-03	U-3319		2022-03-08
N216196-001	9980961	2032-05-03	U-3319		2022-03-08
N216196-001	9193701	2032-10-26	U-3319		2022-03-08
N216196-001	11793806	2033-04-12	U-3320		2023-10-31
N216196-001	RE49582	2035-04-11		Drug substance, Drug product	2023-07-27
N216196-001	11234976	2038-10-11	U-3321		2022-03-08
N216196-001	11254652	2038-11-21		Drug substance, Drug product	2022-03-08
N216196-001	11878049	2041-07-31	U-3782		2024-01-26
N216196-002	10632114	2032-05-03	U-3320		2022-03-08
N216196-002	9682080	2032-05-03	U-3319		2022-03-08
N216196-002	9980961	2032-05-03	U-3319		2022-03-08
N216196-002	9193701	2032-10-26	U-3319		2022-03-08
N216196-002	11793806	2033-04-12	U-3320		2023-10-31
N216196-002	RE49582	2035-04-11		Drug substance, Drug product	2023-07-27
N216196-002	11234976	2038-10-11	U-3321		2022-03-08
N216196-002	11254652	2038-11-21		Drug substance, Drug product	2022-03-08
N216196-002	11878049	2041-07-31	U-3782		2024-01-26
N216196-003	10632114	2032-05-03	U-3320		2022-03-08
N216196-003	9682080	2032-05-03	U-3319		2022-03-08
N216196-003	9980961	2032-05-03	U-3319		2022-03-08
N216196-003	9193701	2032-10-26	U-3319		2022-03-08
N216196-003	11793806	2033-04-12	U-3320		2023-10-31
N216196-003	RE49582	2035-04-11		Drug substance, Drug product	2023-07-27
N216196-003	11234976	2038-10-11	U-3321		2022-03-08
N216196-003	11254652	2038-11-21		Drug substance, Drug product	2022-03-08
N216196-003	11878049	2041-07-31	U-3782		2024-01-26
N216196-004	10632114	2032-05-03	U-4391		2026-01-20
N216196-004	9682080	2032-05-03	U-4392		2026-01-20
N216196-004	9193701	2032-10-26	U-4393		2026-01-20
N216196-004	RE49582	2035-04-11		Drug substance, Drug product	2026-01-20
N216196-004	11254652	2038-11-21		Drug substance, Drug product	2026-01-20
N216196-004	11878049	2041-07-31	U-4390		2026-01-20

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 9 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N216196-001	NCE	2027-02-17
N216196-001	ODE-392	2029-02-17
N216196-002	NCE	2027-02-17
N216196-002	ODE-392	2029-02-17
N216196-003	NCE	2027-02-17
N216196-003	ODE-392	2029-02-17
N216196-004	NCE	2027-02-17
N216196-004	NP	2028-12-23
N216196-004	ODE-522	2032-12-23

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 3 · 103 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	N216196-001	PYRUKYND	EQ 5MG BASE	TABLET / ORAL	RLD	2022-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-002	PYRUKYND	EQ 20MG BASE	TABLET / ORAL	RLD	2022-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-003	PYRUKYND	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-004	AQVESME	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2025-12-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216196-001	PYRUKYND	EQ 5MG BASE	TABLET / ORAL	RLD	2022-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216196-002	PYRUKYND	EQ 20MG BASE	TABLET / ORAL	RLD	2022-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216196-003	PYRUKYND	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216196-004	AQVESME	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2025-12-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216196-001	PYRUKYND	EQ 5MG BASE	TABLET / ORAL	RLD	2022-02-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216196-002	PYRUKYND	EQ 20MG BASE	TABLET / ORAL	RLD	2022-02-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216196-003	PYRUKYND	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-02-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216196-004	AQVESME	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2025-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216196-001	PYRUKYND	EQ 5MG BASE	TABLET / ORAL	RLD	2022-02-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216196-002	PYRUKYND	EQ 20MG BASE	TABLET / ORAL	RLD	2022-02-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216196-003	PYRUKYND	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-02-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216196-001	PYRUKYND	EQ 5MG BASE	TABLET / ORAL	RLD	2022-02-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216196-002	PYRUKYND	EQ 20MG BASE	TABLET / ORAL	RLD	2022-02-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216196-003	PYRUKYND	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-02-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216196-001	PYRUKYND	EQ 5MG BASE	TABLET / ORAL	RLD	2022-02-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216196-002	PYRUKYND	EQ 20MG BASE	TABLET / ORAL	RLD	2022-02-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216196-003	PYRUKYND	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-02-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216196-001	PYRUKYND	EQ 5MG BASE	TABLET / ORAL	RLD	2022-02-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216196-002	PYRUKYND	EQ 20MG BASE	TABLET / ORAL	RLD	2022-02-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216196-003	PYRUKYND	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-02-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216196-001	PYRUKYND	EQ 5MG BASE	TABLET / ORAL	RLD	2022-02-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216196-002	PYRUKYND	EQ 20MG BASE	TABLET / ORAL	RLD	2022-02-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216196-003	PYRUKYND	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-02-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216196-001	PYRUKYND	EQ 5MG BASE	TABLET / ORAL	RLD	2022-02-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216196-002	PYRUKYND	EQ 20MG BASE	TABLET / ORAL	RLD	2022-02-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216196-003	PYRUKYND	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-02-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216196-001	PYRUKYND	EQ 5MG BASE	TABLET / ORAL	RLD	2022-02-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216196-002	PYRUKYND	EQ 20MG BASE	TABLET / ORAL	RLD	2022-02-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216196-003	PYRUKYND	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-02-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216196-001	PYRUKYND	EQ 5MG BASE	TABLET / ORAL	RLD	2022-02-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216196-002	PYRUKYND	EQ 20MG BASE	TABLET / ORAL	RLD	2022-02-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216196-003	PYRUKYND	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-02-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216196-001	PYRUKYND	EQ 5MG BASE	TABLET / ORAL	RLD	2022-02-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216196-002	PYRUKYND	EQ 20MG BASE	TABLET / ORAL	RLD	2022-02-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216196-003	PYRUKYND	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-02-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216196-001	PYRUKYND	EQ 5MG BASE	TABLET / ORAL	RLD	2022-02-17	`79d66fd596c7…`

Observed Orange Book patent history#

Patent history page 1 of 21 · 837 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	N216196-001	10632114	2032-05-03	U-3320		2022-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-001	9682080	2032-05-03	U-3319		2022-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-001	9980961	2032-05-03	U-3319		2022-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-001	9193701	2032-10-26	U-3319		2022-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-001	11793806	2033-04-12	U-3320		2023-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-001	RE49582	2035-04-11		Drug substance, Drug product	2023-07-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-001	11234976	2038-10-11	U-3321		2022-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-001	11254652	2038-11-21		Drug substance, Drug product	2022-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-001	11878049	2041-07-31	U-3782		2024-01-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-002	10632114	2032-05-03	U-3320		2022-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-002	9682080	2032-05-03	U-3319		2022-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-002	9980961	2032-05-03	U-3319		2022-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-002	9193701	2032-10-26	U-3319		2022-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-002	11793806	2033-04-12	U-3320		2023-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-002	RE49582	2035-04-11		Drug substance, Drug product	2023-07-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-002	11234976	2038-10-11	U-3321		2022-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-002	11254652	2038-11-21		Drug substance, Drug product	2022-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-002	11878049	2041-07-31	U-3782		2024-01-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-003	10632114	2032-05-03	U-3320		2022-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-003	9682080	2032-05-03	U-3319		2022-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-003	9980961	2032-05-03	U-3319		2022-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-003	9193701	2032-10-26	U-3319		2022-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-003	11793806	2033-04-12	U-3320		2023-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-003	RE49582	2035-04-11		Drug substance, Drug product	2023-07-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-003	11234976	2038-10-11	U-3321		2022-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-003	11254652	2038-11-21		Drug substance, Drug product	2022-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-003	11878049	2041-07-31	U-3782		2024-01-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-004	10632114	2032-05-03	U-4391		2026-01-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-004	9682080	2032-05-03	U-4392		2026-01-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-004	9193701	2032-10-26	U-4393		2026-01-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-004	RE49582	2035-04-11		Drug substance, Drug product	2026-01-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-004	11254652	2038-11-21		Drug substance, Drug product	2026-01-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-004	11878049	2041-07-31	U-4390		2026-01-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216196-001	10632114	2032-05-03	U-3320		2022-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216196-001	9682080	2032-05-03	U-3319		2022-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216196-001	9980961	2032-05-03	U-3319		2022-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216196-001	9193701	2032-10-26	U-3319		2022-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216196-001	11793806	2033-04-12	U-3320		2023-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216196-001	RE49582	2035-04-11		Drug substance, Drug product	2023-07-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216196-001	11234976	2038-10-11	U-3321		2022-03-08	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 180 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	N216196-001	NCE	2027-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-001	ODE-392	2029-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-002	NCE	2027-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-002	ODE-392	2029-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-003	NCE	2027-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-003	ODE-392	2029-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-004	NCE	2027-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-004	NP	2028-12-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216196-004	ODE-522	2032-12-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216196-001	NCE	2027-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216196-001	ODE-392	2029-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216196-002	NCE	2027-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216196-002	ODE-392	2029-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216196-003	NCE	2027-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216196-003	ODE-392	2029-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216196-004	NCE	2027-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216196-004	NP	2028-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216196-004	ODE-522	2032-12-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216196-001	NCE	2027-02-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216196-001	ODE-392	2029-02-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216196-002	NCE	2027-02-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216196-002	ODE-392	2029-02-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216196-003	NCE	2027-02-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216196-003	ODE-392	2029-02-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216196-001	NCE	2027-02-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216196-001	ODE-392	2029-02-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216196-002	NCE	2027-02-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216196-002	ODE-392	2029-02-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216196-003	NCE	2027-02-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216196-003	ODE-392	2029-02-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216196-001	NCE	2027-02-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216196-001	ODE-392	2029-02-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216196-002	NCE	2027-02-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216196-002	ODE-392	2029-02-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216196-003	NCE	2027-02-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216196-003	ODE-392	2029-02-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216196-001	NCE	2027-02-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216196-001	ODE-392	2029-02-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216196-002	NCE	2027-02-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216196-002	ODE-392	2029-02-17	`fd3edfee7708…`

Additional Listing Data#

Finished product: Yes
Brand name base: PYRUKYND
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MITAPIVAT	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2WTV10SIKH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 18 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2594473	Internal RxNorm lookup
2594479	Internal RxNorm lookup
2594496	Internal RxNorm lookup
2594498	Internal RxNorm lookup
2594501	Internal RxNorm lookup
2594503	Internal RxNorm lookup
2594741	Internal RxNorm lookup
2594742	Internal RxNorm lookup
2594743	Internal RxNorm lookup
2594744	Internal RxNorm lookup
2594745	Internal RxNorm lookup
2594746	Internal RxNorm lookup
2594747	Internal RxNorm lookup
2594748	Internal RxNorm lookup
2594749	Internal RxNorm lookup
2594750	Internal RxNorm lookup
2594794	Internal RxNorm lookup
2594795	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
4ccee896-e313-4c6c-9674-b4746ada0a90	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71334-215-07	PYRUKYND	7 in 1 BLISTER PACK	TABLET, FILM COATED	7	50 mg	9
71334-215-14	PYRUKYND	14 in 1 BLISTER PACK	TABLET, FILM COATED	14		9
71334-215-50	PYRUKYND	4 in 1 CARTON	TABLET, FILM COATED	4		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71334-215-14	EA - Each	71334-215	6a7093ed-5a06-4f46-a4a0-b8c4159e8a22	1	2022-03-09
71334-215-50	EA - Each	71334-215	1c258aaf-aa47-4aef-8c32-650996093d45	1	2022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71334-215	PYRUKYND (MITAPIVAT) TABLET, FILM COATED PYRUKYND (MITAPIVAT) KIT [AGIOS PHARMACEUTICALS, INC.]	5	Current NDC, Legacy NDC, 2 package rows	20250119_4ccee896-e313-4c6c-9674-b4746ada0a90.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AQVESME	MITAPIVAT	Agios Pharmaceuticals, Inc.	1d4e2654-1636-0d01-e063-6394a90af303	2026-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 216196 application number: NDA216196
PYRUKYND	MITAPIVAT	Agios Pharmaceuticals, Inc.	4ccee896-e313-4c6c-9674-b4746ada0a90	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 216196 application number: NDA216196 ndc (product): 71334-215

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2WTV10SIKH	MITAPIVAT	1260075-17-9	MITAPIVAT

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2594742	{56 (mitapivat 20 MG Oral Tablet [Pyrukynd]) } Pack [Pyrukynd 20 MG 4-Week]	BPCK	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594744	{56 (mitapivat 5 MG Oral Tablet [Pyrukynd]) } Pack [Pyrukynd 5 MG 4-Week]	BPCK	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594795	{56 (mitapivat 50 MG Oral Tablet [Pyrukynd]) } Pack [Pyrukynd 50 MG 4-Week]	BPCK	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594748	{7 (mitapivat 20 MG Oral Tablet [Pyrukynd]) / 7 (mitapivat 5 MG Oral Tablet [Pyrukynd]) } Pack [Pyrukynd 5 MG / 20 MG Taper]	BPCK	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594750	{7 (mitapivat 20 MG Oral Tablet [Pyrukynd]) / 7 (mitapivat 50 MG Oral Tablet [Pyrukynd]) } Pack [Pyrukynd 20 MG / 50 MG Taper]	BPCK	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594746	{7 (mitapivat 5 MG Oral Tablet [Pyrukynd]) } Pack [Pyrukynd 5 MG Taper]	BPCK	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594741	{56 (mitapivat 20 MG Oral Tablet) } Pack	GPCK	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594743	{56 (mitapivat 5 MG Oral Tablet) } Pack	GPCK	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594794	{56 (mitapivat 50 MG Oral Tablet) } Pack	GPCK	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594747	{7 (mitapivat 20 MG Oral Tablet) / 7 (mitapivat 5 MG Oral Tablet) } Pack	GPCK	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594749	{7 (mitapivat 20 MG Oral Tablet) / 7 (mitapivat 50 MG Oral Tablet) } Pack	GPCK	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594745	{7 (mitapivat 5 MG Oral Tablet) } Pack	GPCK	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594741	mitapivat 20 MG 4-Week Pack	PSN	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594473	mitapivat 20 MG Oral Tablet	PSN	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594747	mitapivat 5 MG / 20 MG Taper Pack	PSN	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594743	mitapivat 5 MG 4-Week Pack	PSN	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594496	mitapivat 5 MG Oral Tablet	PSN	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594745	mitapivat 5 MG Taper Pack	PSN	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594749	mitapivat 50 MG / 20 MG Taper Pack	PSN	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594794	mitapivat 50 MG 4-Week Pack	PSN	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594501	mitapivat 50 MG Oral Tablet	PSN	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594750	Pyrukynd 20 MG / 50 MG Taper Pack	PSN	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594742	Pyrukynd 20 MG 4-Week Pack	PSN	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594479	pyrukynd 20 MG Oral Tablet	PSN	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594748	Pyrukynd 5 MG / 20 MG Taper Pack	PSN	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594744	Pyrukynd 5 MG 4-Week Pack	PSN	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594498	pyrukynd 5 MG Oral Tablet	PSN	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594746	Pyrukynd 5 MG Taper Pack	PSN	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594795	Pyrukynd 50 MG 4-Week Pack	PSN	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594503	pyrukynd 50 MG Oral Tablet	PSN	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594479	mitapivat 20 MG Oral Tablet [Pyrukynd]	SBD	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594498	mitapivat 5 MG Oral Tablet [Pyrukynd]	SBD	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594503	mitapivat 50 MG Oral Tablet [Pyrukynd]	SBD	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594473	mitapivat 20 MG Oral Tablet	SCD	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594496	mitapivat 5 MG Oral Tablet	SCD	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594501	mitapivat 50 MG Oral Tablet	SCD	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594473	mitapivat 20 MG (as mitapivat sulfate 23.4 MG) Oral Tablet	SY	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594741	mitapivat 20 MG 4-Week Pack	SY	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594496	mitapivat 5 MG (as mitapivat sulfate 5.85 MG) Oral Tablet	SY	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594747	mitapivat 5 MG / 20 MG Taper Pack	SY	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594743	mitapivat 5 MG 4-Week Pack	SY	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594745	mitapivat 5 MG Taper Pack	SY	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594501	mitapivat 50 MG (as mitapivat sulfate 58.5 MG) Oral Tablet	SY	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594749	mitapivat 50 MG / 20 MG Taper Pack	SY	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594794	mitapivat 50 MG 4-Week Pack	SY	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594479	Pyrukynd 20 MG (as mitapivat sulfate 23.4 MG) Oral Tablet	SY	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594750	Pyrukynd 20 MG / 50 MG Taper Pack	SY	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594742	Pyrukynd 20 MG 4-Week Pack	SY	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594479	Pyrukynd 20 MG Oral Tablet	SY	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594498	Pyrukynd 5 MG (as mitapivat sulfate 5.85 MG) Oral Tablet	SY	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594748	Pyrukynd 5 MG / 20 MG Taper Pack	SY	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594744	Pyrukynd 5 MG 4-Week Pack	SY	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594498	Pyrukynd 5 MG Oral Tablet	SY	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594746	Pyrukynd 5 MG Taper Pack	SY	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594503	Pyrukynd 50 MG (as mitapivat sulfate 58.5 MG) Oral Tablet	SY	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594795	Pyrukynd 50 MG 4-Week Pack	SY	4ccee896-e313-4c6c-9674-b4746ada0a90	9
2594503	Pyrukynd 50 MG Oral Tablet	SY	4ccee896-e313-4c6c-9674-b4746ada0a90	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71334-215-07	71334021507	7 in 1 BLISTER PACK						Historical
71334-215-14	71334021514	14 in 1 BLISTER PACK						Historical
71334-215-50	71334021550	4 BLISTER PACK in 1 CARTON (71334-215-50) / 14 TABLET, FILM COATED in 1 BLISTER PACK (71334-215-14)	4 blister pack	2022-02-18	0000-00-00	No	No	Current