AZSTARYS

Product NDC: 65038-561
Requested package NDC: 65038-561-99
11-digit product format: 650380561
Labeler code: 65038
Product ID: 65038-561_515506d2-5c3d-92d2-e063-6394a90a0603
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Serdexmethylphenidate and Dexmethylphenidate
Dosage form: CAPSULE
Route: ORAL
Labeler: Commave Sub, LLC
Application: NDA212994
Marketing category: NDA
Marketing start: 2021-07-16
Substance: DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE
Active strength: 10.4; 52.3 mg/1; mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]
DEA schedule: CII
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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N212994-001	AZSTARYS	DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE	EQ 5.2MG BASE;EQ 26.1MG BASE	CAPSULE / ORAL	RLD	2021-05-07
N212994-002	AZSTARYS	DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE	EQ 7.8MG BASE;EQ 39.2MG BASE	CAPSULE / ORAL	RLD	2021-05-07
N212994-003	AZSTARYS	DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE	EQ 10.4MG BASE;EQ 52.3MG BASE	CAPSULE / ORAL	RLD, RS	2021-05-07

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212994-001	9079928	2035-05-07		Drug product	2021-05-17
N212994-001	10584112	2037-12-09		Drug substance, Drug product	2021-05-17
N212994-001	10584113	2037-12-09		Drug product	2021-05-17
N212994-001	10759778	2037-12-09		Drug product	2021-05-17
N212994-001	10858341	2037-12-09	U-3094		2021-05-17
N212994-001	10954213	2037-12-09	U-3094		2021-05-17
N212994-002	9079928	2035-05-07		Drug product	2021-05-17
N212994-002	10584112	2037-12-09		Drug substance, Drug product	2021-05-17
N212994-002	10584113	2037-12-09		Drug product	2021-05-17
N212994-002	10759778	2037-12-09		Drug product	2021-05-17
N212994-002	10858341	2037-12-09	U-3094		2021-05-17
N212994-002	10954213	2037-12-09	U-3094		2021-05-17
N212994-003	9079928	2035-05-07		Drug product	2021-05-17
N212994-003	10584112	2037-12-09		Drug substance, Drug product	2021-05-17
N212994-003	10584113	2037-12-09		Drug product	2021-05-17
N212994-003	10759778	2037-12-09		Drug product	2021-05-17
N212994-003	10858341	2037-12-09	U-3094		2021-05-17
N212994-003	10954213	2037-12-09	U-3094		2021-05-17

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N212994-001	NCE	2026-05-07
N212994-002	NCE	2026-05-07
N212994-003	NCE	2026-05-07

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 · 99 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N212994-001	AZSTARYS	EQ 5.2MG BASE;EQ 26.1MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212994-002	AZSTARYS	EQ 7.8MG BASE;EQ 39.2MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212994-003	AZSTARYS	EQ 10.4MG BASE;EQ 52.3MG BASE	CAPSULE / ORAL	RLD, RS	2021-05-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212994-001	AZSTARYS	EQ 5.2MG BASE;EQ 26.1MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212994-002	AZSTARYS	EQ 7.8MG BASE;EQ 39.2MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212994-003	AZSTARYS	EQ 10.4MG BASE;EQ 52.3MG BASE	CAPSULE / ORAL	RLD, RS	2021-05-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212994-001	AZSTARYS	EQ 5.2MG BASE;EQ 26.1MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212994-002	AZSTARYS	EQ 7.8MG BASE;EQ 39.2MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212994-003	AZSTARYS	EQ 10.4MG BASE;EQ 52.3MG BASE	CAPSULE / ORAL	RLD, RS	2021-05-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212994-001	AZSTARYS	EQ 5.2MG BASE;EQ 26.1MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212994-002	AZSTARYS	EQ 7.8MG BASE;EQ 39.2MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212994-003	AZSTARYS	EQ 10.4MG BASE;EQ 52.3MG BASE	CAPSULE / ORAL	RLD, RS	2021-05-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212994-001	AZSTARYS	EQ 5.2MG BASE;EQ 26.1MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212994-002	AZSTARYS	EQ 7.8MG BASE;EQ 39.2MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212994-003	AZSTARYS	EQ 10.4MG BASE;EQ 52.3MG BASE	CAPSULE / ORAL	RLD, RS	2021-05-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212994-001	AZSTARYS	EQ 5.2MG BASE;EQ 26.1MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212994-002	AZSTARYS	EQ 7.8MG BASE;EQ 39.2MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212994-003	AZSTARYS	EQ 10.4MG BASE;EQ 52.3MG BASE	CAPSULE / ORAL	RLD, RS	2021-05-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212994-001	AZSTARYS	EQ 5.2MG BASE;EQ 26.1MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212994-002	AZSTARYS	EQ 7.8MG BASE;EQ 39.2MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212994-003	AZSTARYS	EQ 10.4MG BASE;EQ 52.3MG BASE	CAPSULE / ORAL	RLD, RS	2021-05-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212994-001	AZSTARYS	EQ 5.2MG BASE;EQ 26.1MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212994-002	AZSTARYS	EQ 7.8MG BASE;EQ 39.2MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212994-003	AZSTARYS	EQ 10.4MG BASE;EQ 52.3MG BASE	CAPSULE / ORAL	RLD, RS	2021-05-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212994-001	AZSTARYS	EQ 5.2MG BASE;EQ 26.1MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212994-002	AZSTARYS	EQ 7.8MG BASE;EQ 39.2MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212994-003	AZSTARYS	EQ 10.4MG BASE;EQ 52.3MG BASE	CAPSULE / ORAL	RLD, RS	2021-05-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212994-001	AZSTARYS	EQ 5.2MG BASE;EQ 26.1MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212994-002	AZSTARYS	EQ 7.8MG BASE;EQ 39.2MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212994-003	AZSTARYS	EQ 10.4MG BASE;EQ 52.3MG BASE	CAPSULE / ORAL	RLD, RS	2021-05-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212994-001	AZSTARYS	EQ 5.2MG BASE;EQ 26.1MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212994-002	AZSTARYS	EQ 7.8MG BASE;EQ 39.2MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212994-003	AZSTARYS	EQ 10.4MG BASE;EQ 52.3MG BASE	CAPSULE / ORAL	RLD, RS	2021-05-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212994-001	AZSTARYS	EQ 5.2MG BASE;EQ 26.1MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212994-002	AZSTARYS	EQ 7.8MG BASE;EQ 39.2MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212994-003	AZSTARYS	EQ 10.4MG BASE;EQ 52.3MG BASE	CAPSULE / ORAL	RLD, RS	2021-05-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212994-001	AZSTARYS	EQ 5.2MG BASE;EQ 26.1MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212994-002	AZSTARYS	EQ 7.8MG BASE;EQ 39.2MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212994-003	AZSTARYS	EQ 10.4MG BASE;EQ 52.3MG BASE	CAPSULE / ORAL	RLD, RS	2021-05-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212994-001	AZSTARYS	EQ 5.2MG BASE;EQ 26.1MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 15 · 594 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N212994-001	9079928	2032-07-27		Drug product	2021-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212994-001	10584112	2037-12-09		Drug substance, Drug product	2021-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212994-001	10584113	2037-12-09		Drug product	2021-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212994-001	10759778	2037-12-09		Drug product	2021-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212994-001	10858341	2037-12-09	U-3094		2021-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212994-001	10954213	2037-12-09	U-3094		2021-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212994-002	9079928	2032-07-27		Drug product	2021-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212994-002	10584112	2037-12-09		Drug substance, Drug product	2021-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212994-002	10584113	2037-12-09		Drug product	2021-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212994-002	10759778	2037-12-09		Drug product	2021-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212994-002	10858341	2037-12-09	U-3094		2021-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212994-002	10954213	2037-12-09	U-3094		2021-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212994-003	9079928	2032-07-27		Drug product	2021-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212994-003	10584112	2037-12-09		Drug substance, Drug product	2021-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212994-003	10584113	2037-12-09		Drug product	2021-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212994-003	10759778	2037-12-09		Drug product	2021-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212994-003	10858341	2037-12-09	U-3094		2021-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212994-003	10954213	2037-12-09	U-3094		2021-05-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212994-001	9079928	2032-07-27		Drug product	2021-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212994-001	10584112	2037-12-09		Drug substance, Drug product	2021-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212994-001	10584113	2037-12-09		Drug product	2021-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212994-001	10759778	2037-12-09		Drug product	2021-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212994-001	10858341	2037-12-09	U-3094		2021-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212994-001	10954213	2037-12-09	U-3094		2021-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212994-002	9079928	2032-07-27		Drug product	2021-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212994-002	10584112	2037-12-09		Drug substance, Drug product	2021-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212994-002	10584113	2037-12-09		Drug product	2021-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212994-002	10759778	2037-12-09		Drug product	2021-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212994-002	10858341	2037-12-09	U-3094		2021-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212994-002	10954213	2037-12-09	U-3094		2021-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212994-003	9079928	2032-07-27		Drug product	2021-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212994-003	10584112	2037-12-09		Drug substance, Drug product	2021-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212994-003	10584113	2037-12-09		Drug product	2021-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212994-003	10759778	2037-12-09		Drug product	2021-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212994-003	10858341	2037-12-09	U-3094		2021-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212994-003	10954213	2037-12-09	U-3094		2021-05-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212994-001	9079928	2032-07-27		Drug product	2021-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212994-001	10584112	2037-12-09		Drug substance, Drug product	2021-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212994-001	10584113	2037-12-09		Drug product	2021-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212994-001	10759778	2037-12-09		Drug product	2021-05-17	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N212994-001	NCE	2026-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212994-002	NCE	2026-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212994-003	NCE	2026-05-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212994-001	NCE	2026-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212994-002	NCE	2026-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212994-003	NCE	2026-05-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212994-001	NCE	2026-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212994-002	NCE	2026-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212994-003	NCE	2026-05-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212994-001	NCE	2026-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212994-002	NCE	2026-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212994-003	NCE	2026-05-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212994-001	NCE	2026-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212994-002	NCE	2026-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212994-003	NCE	2026-05-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212994-001	NCE	2026-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212994-002	NCE	2026-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212994-003	NCE	2026-05-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212994-001	NCE	2026-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212994-002	NCE	2026-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212994-003	NCE	2026-05-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212994-001	NCE	2026-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212994-002	NCE	2026-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212994-003	NCE	2026-05-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212994-001	NCE	2026-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212994-002	NCE	2026-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212994-003	NCE	2026-05-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212994-001	NCE	2026-05-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212994-002	NCE	2026-05-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212994-003	NCE	2026-05-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212994-001	NCE	2026-05-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212994-002	NCE	2026-05-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212994-003	NCE	2026-05-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212994-001	NCE	2026-05-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212994-002	NCE	2026-05-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212994-003	NCE	2026-05-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212994-001	NCE	2026-05-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212994-002	NCE	2026-05-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212994-003	NCE	2026-05-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212994-001	NCE	2026-05-07	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SERDEXMETHYLPHENIDATE CHLORIDE	10.4 mg/1
DEXMETHYLPHENIDATE HYDROCHLORIDE	52.3 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
FN54BT298Y	Internal UNII lookup
1678OK0E08	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2562186	Internal RxNorm lookup
2562187	Internal RxNorm lookup
2562191	Internal RxNorm lookup
2562194	Internal RxNorm lookup
2562199	Internal RxNorm lookup
2562204	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
00b5e716-5564-4bbd-acaf-df2bc45a5663	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
1ff349b0-f325-4585-9c0d-7dc58eb1bc1b	Product name	1	20210818
7d5b6b15-5a1e-e1e5-992d-90d0701572ad	Product name	9	20210511
ccfbb2ac-2915-4b21-1d79-8a93f773e70f	Product name	9	20200714

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65038-561-99	AZSTARYS	100 in 1 BOTTLE, PLASTIC	CAPSULE	100		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65038-561-99	EA - Each	65038-561	d76ab9dc-4597-4c80-8996-6ea6718b9d04	1	2021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65038-561	AZSTARYS (SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE) CAPSULE [CORIUM, LLC.]	7	Current NDC, Legacy NDC, 1 package rows	20231026_00b5e716-5564-4bbd-acaf-df2bc45a5663.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
AZSTARYS	SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE	Commave Sub, LLC	00b5e716-5564-4bbd-acaf-df2bc45a5663	2026-05-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 212994 application number: NDA212994 ndc (package): 65038-561-99 ndc (product): 65038-561 ndc11 (package): 65038056199

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1678OK0E08	DEXMETHYLPHENIDATE HYDROCHLORIDE	19262-68-1	DEXMETHYLPHENIDATE HYDROCHLORIDE
FN54BT298Y	SERDEXMETHYLPHENIDATE CHLORIDE	1996626-30-2	SERDEXMETHYLPHENIDATE CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2562199	Azstarys 10.4 MG / 52.3 MG Oral Capsule	PSN	00b5e716-5564-4bbd-acaf-df2bc45a5663	9
2562186	Azstarys 5.2 MG / 26.1 MG Oral Capsule	PSN	00b5e716-5564-4bbd-acaf-df2bc45a5663	9
2562204	Azstarys 7.8 MG / 39.2 MG Oral Capsule	PSN	00b5e716-5564-4bbd-acaf-df2bc45a5663	9
2562194	dexmethylphenidate 10.4 MG / serdexmethylphenidate 52.3 MG Oral Capsule	PSN	00b5e716-5564-4bbd-acaf-df2bc45a5663	9
2562187	dexmethylphenidate 5.2 MG / serdexmethylphenidate 26.1 MG Oral Capsule	PSN	00b5e716-5564-4bbd-acaf-df2bc45a5663	9
2562191	dexmethylphenidate 7.8 MG / serdexmethylphenidate 39.2 MG Oral Capsule	PSN	00b5e716-5564-4bbd-acaf-df2bc45a5663	9
2562199	dexmethylphenidate 10.4 MG / serdexmethylphenidate 52.3 MG Oral Capsule [Azstarys]	SBD	00b5e716-5564-4bbd-acaf-df2bc45a5663	9
2562186	dexmethylphenidate 5.2 MG / serdexmethylphenidate 26.1 MG Oral Capsule [Azstarys]	SBD	00b5e716-5564-4bbd-acaf-df2bc45a5663	9
2562204	dexmethylphenidate 7.8 MG / serdexmethylphenidate 39.2 MG Oral Capsule [Azstarys]	SBD	00b5e716-5564-4bbd-acaf-df2bc45a5663	9
2562194	dexmethylphenidate 10.4 MG / serdexmethylphenidate 52.3 MG Oral Capsule	SCD	00b5e716-5564-4bbd-acaf-df2bc45a5663	9
2562187	dexmethylphenidate 5.2 MG / serdexmethylphenidate 26.1 MG Oral Capsule	SCD	00b5e716-5564-4bbd-acaf-df2bc45a5663	9
2562191	dexmethylphenidate 7.8 MG / serdexmethylphenidate 39.2 MG Oral Capsule	SCD	00b5e716-5564-4bbd-acaf-df2bc45a5663	9
2562199	Azstarys (dexmethylphenidate 10.4 MG (as dexmethylphenidate hydrochloride 12 MG) / serdexmethylphenidate 52.3 MG (as serdexmethylphenidate chloride 56 MG)) Oral Capsule	SY	00b5e716-5564-4bbd-acaf-df2bc45a5663	9
2562186	Azstarys (dexmethylphenidate 5.2 MG (as dexmethylphenidate hydrochloride 6 MG) / serdexmethylphenidate 26.1 MG (as serdexmethylphenidate chloride 28 MG)) Oral Capsule	SY	00b5e716-5564-4bbd-acaf-df2bc45a5663	9
2562204	Azstarys (dexmethylphenidate 7.8 MG (as dexmethylphenidate hydrochloride 9 MG) / serdexmethylphenidate 39.2 MG (as serdexmethylphenidate chloride 42 MG)) Oral Capsule	SY	00b5e716-5564-4bbd-acaf-df2bc45a5663	9
2562194	dexmethylphenidate 10.4 MG (as dexmethylphenidate hydrochloride 12 MG) / serdexmethylphenidate 52.3 MG (as serdexmethylphenidate chloride 56 MG) Oral Capsule	SY	00b5e716-5564-4bbd-acaf-df2bc45a5663	9
2562187	dexmethylphenidate 5.2 MG (as dexmethylphenidate hydrochloride 6 MG) / serdexmethylphenidate 26.1 MG (as serdexmethylphenidate chloride 28 MG) Oral Capsule	SY	00b5e716-5564-4bbd-acaf-df2bc45a5663	9
2562191	dexmethylphenidate 7.8 MG (as dexmethylphenidate hydrochloride 9 MG) / serdexmethylphenidate 39.2 MG (as serdexmethylphenidate chloride 42 MG) Oral Capsule	SY	00b5e716-5564-4bbd-acaf-df2bc45a5663	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65038-561-99	65038056199	100 CAPSULE in 1 BOTTLE, PLASTIC (65038-561-99)	100 capsule	2021-07-16	0000-00-00	No	No	Current