MYDAYIS

Product NDC: 54092-471
11-digit product format: 540920471
Labeler code: 54092
Product ID: 54092-471_13a2ab7d-af84-4e46-a58f-9e9c17b5c0e5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Takeda Pharmaceuticals America, Inc.
Application: NDA022063
Marketing category: NDA
Marketing start: 2017-06-20
Substance: AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Active strength: 6.25; 6.25; 6.25; 6.25 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022063-001	MYDAYIS	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20
N022063-002	MYDAYIS	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20
N022063-003	MYDAYIS	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20
N022063-004	MYDAYIS	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2017-06-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N022063-001	AB2
N022063-002	AB2
N022063-003	AB2
N022063-004	AB2

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022063-001	9173857	2026-05-12	U-2025		2017-07-07
N022063-001	8846100	2029-08-24		Drug product	2017-07-07
N022063-002	9173857	2026-05-12	U-2025		2017-07-07
N022063-002	8846100	2029-08-24		Drug product	2017-07-07
N022063-003	9173857	2026-05-12	U-2025		2017-07-07
N022063-003	8846100	2029-08-24		Drug product	2017-07-07
N022063-004	9173857	2026-05-12	U-2025		2017-07-07
N022063-004	8846100	2029-08-24		Drug product	2017-07-07

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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022063-001	MYDAYIS	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022063-002	MYDAYIS	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022063-003	MYDAYIS	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022063-004	MYDAYIS	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2017-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022063-001	MYDAYIS	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022063-002	MYDAYIS	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022063-003	MYDAYIS	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022063-004	MYDAYIS	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2017-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022063-001	MYDAYIS	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022063-002	MYDAYIS	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022063-003	MYDAYIS	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022063-004	MYDAYIS	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2017-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022063-001	MYDAYIS	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022063-002	MYDAYIS	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022063-003	MYDAYIS	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022063-004	MYDAYIS	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2017-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022063-001	MYDAYIS	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022063-002	MYDAYIS	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022063-003	MYDAYIS	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022063-004	MYDAYIS	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2017-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022063-001	MYDAYIS	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022063-002	MYDAYIS	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022063-003	MYDAYIS	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022063-004	MYDAYIS	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2017-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022063-001	MYDAYIS	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022063-002	MYDAYIS	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022063-003	MYDAYIS	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022063-004	MYDAYIS	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2017-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022063-001	MYDAYIS	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022063-002	MYDAYIS	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022063-003	MYDAYIS	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022063-004	MYDAYIS	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2017-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022063-001	MYDAYIS	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022063-002	MYDAYIS	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022063-003	MYDAYIS	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022063-004	MYDAYIS	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2017-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022063-001	MYDAYIS	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022063-002	MYDAYIS	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022063-003	MYDAYIS	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022063-004	MYDAYIS	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2017-06-20	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022063-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022063-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022063-003	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022063-004	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022063-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022063-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022063-003	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022063-004	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022063-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022063-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022063-003	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022063-004	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022063-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022063-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022063-003	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022063-004	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022063-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022063-002	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022063-003	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022063-004	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022063-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022063-002	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022063-003	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022063-004	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022063-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022063-002	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022063-003	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022063-004	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022063-001	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022063-002	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022063-003	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022063-004	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022063-001	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022063-002	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022063-003	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022063-004	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022063-001	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022063-002	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022063-003	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022063-004	AB2	1	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 424 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	N022063-001	9173857	2026-05-12	U-2025		2017-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022063-001	8846100	2029-08-24		Drug product	2017-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022063-002	9173857	2026-05-12	U-2025		2017-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022063-002	8846100	2029-08-24		Drug product	2017-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022063-003	9173857	2026-05-12	U-2025		2017-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022063-003	8846100	2029-08-24		Drug product	2017-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022063-004	9173857	2026-05-12	U-2025		2017-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022063-004	8846100	2029-08-24		Drug product	2017-07-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022063-001	9173857	2026-05-12	U-2025		2017-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022063-001	8846100	2029-08-24		Drug product	2017-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022063-002	9173857	2026-05-12	U-2025		2017-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022063-002	8846100	2029-08-24		Drug product	2017-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022063-003	9173857	2026-05-12	U-2025		2017-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022063-003	8846100	2029-08-24		Drug product	2017-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022063-004	9173857	2026-05-12	U-2025		2017-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022063-004	8846100	2029-08-24		Drug product	2017-07-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022063-001	9173857	2026-05-12	U-2025		2017-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022063-001	8846100	2029-08-24		Drug product	2017-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022063-002	9173857	2026-05-12	U-2025		2017-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022063-002	8846100	2029-08-24		Drug product	2017-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022063-003	9173857	2026-05-12	U-2025		2017-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022063-003	8846100	2029-08-24		Drug product	2017-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022063-004	9173857	2026-05-12	U-2025		2017-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022063-004	8846100	2029-08-24		Drug product	2017-07-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022063-001	9173857	2026-05-12	U-2025		2017-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022063-001	8846100	2029-08-24		Drug product	2017-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022063-002	9173857	2026-05-12	U-2025		2017-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022063-002	8846100	2029-08-24		Drug product	2017-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022063-003	9173857	2026-05-12	U-2025		2017-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022063-003	8846100	2029-08-24		Drug product	2017-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022063-004	9173857	2026-05-12	U-2025		2017-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022063-004	8846100	2029-08-24		Drug product	2017-07-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022063-001	9173857	2026-05-12	U-2025		2017-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022063-001	8846100	2029-08-24		Drug product	2017-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022063-002	9173857	2026-05-12	U-2025		2017-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022063-002	8846100	2029-08-24		Drug product	2017-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022063-003	9173857	2026-05-12	U-2025		2017-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022063-003	8846100	2029-08-24		Drug product	2017-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022063-004	9173857	2026-05-12	U-2025		2017-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022063-004	8846100	2029-08-24		Drug product	2017-07-07	`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 160 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022063-001	M-248	2022-09-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022063-001	PED	2023-03-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022063-002	M-248	2022-09-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022063-002	PED	2023-03-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022063-003	M-248	2022-09-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022063-003	PED	2023-03-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022063-004	M-248	2022-09-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022063-004	PED	2023-03-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022063-001	M-248	2022-09-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022063-001	PED	2023-03-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022063-002	M-248	2022-09-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022063-002	PED	2023-03-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022063-003	M-248	2022-09-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022063-003	PED	2023-03-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022063-004	M-248	2022-09-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022063-004	PED	2023-03-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022063-001	M-248	2022-09-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022063-001	PED	2023-03-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022063-002	M-248	2022-09-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022063-002	PED	2023-03-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022063-003	M-248	2022-09-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022063-003	PED	2023-03-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022063-004	M-248	2022-09-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022063-004	PED	2023-03-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022063-001	NP	2020-06-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022063-002	NP	2020-06-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022063-003	NP	2020-06-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022063-004	NP	2020-06-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022063-001	M-248	2022-09-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022063-001	PED	2023-03-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022063-002	M-248	2022-09-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022063-002	PED	2023-03-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022063-003	M-248	2022-09-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022063-003	PED	2023-03-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022063-004	M-248	2022-09-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022063-004	PED	2023-03-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022063-001	M-248	2022-09-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022063-001	PED	2023-03-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022063-002	M-248	2022-09-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022063-002	PED	2023-03-13	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROAMPHETAMINE SULFATE	6.25 mg/1
DEXTROAMPHETAMINE SACCHARATE	6.25 mg/1
AMPHETAMINE ASPARTATE MONOHYDRATE	6.25 mg/1
AMPHETAMINE SULFATE	6.25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6DPV8NK46S	Internal UNII lookup
O1ZPV620O4	Internal UNII lookup
G83415V073	Internal UNII lookup
JJ768O327N	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1927610	Internal RxNorm lookup
1927616	Internal RxNorm lookup
1927617	Internal RxNorm lookup
1927619	Internal RxNorm lookup
1927630	Internal RxNorm lookup
1927632	Internal RxNorm lookup
1927637	Internal RxNorm lookup
1927639	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
141a7970-3f06-44ea-9ab7-aeece2c085fc	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0f66b30d-6b15-4b2d-91a5-1531b9bb6d21	Product name	7	20250625
917bdf48-c3f5-4a58-ac8e-d2d94a9c1e2b	Product name	2	20250616
8b92ab59-8b26-4c89-a2d6-8d5140526ec6	Product name	3	20231213
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
b4c312b9-fad5-247e-cef9-87a74220463d	Product name	5	20230426
8170729e-5ba4-46f9-830f-5f0fae5942ce	Product name	1	20230103
4496d022-9224-4ee0-943a-50fbe6cd7123	Product name	2	20220901
2a7aa275-a4ca-44eb-971f-47427a374085	Product name	9	20220615
93730fbf-8b45-4623-b27d-cf03825d04b3	Product name	5	20220314
aa1b3c66-c4f6-78f2-abd3-31cc9d555e27	Product name	5	20190913
b4c312b9-fad5-247e-cef9-87a74220463d	Product name	4	20171211
57953747-955c-4dd8-9164-49d8ea877eae	Product name	1	20171113
fcc7ea58-a369-4e91-b092-5cde9ac2669f	Product name	1	20160224
ffdf7f68-0f44-4dd6-a026-336dcb345fc4	Product name	1	20151109

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54092-471-01	MYDAYIS	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54092-471-01	EA - Each	54092-471	5f5abad4-43b0-496c-b15c-e5068a47b45a	1	2017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54092-471	MYDAYIS (DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, AND AMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.]	11	Current NDC, Legacy NDC, 1 package rows	20250321_141a7970-3f06-44ea-9ab7-aeece2c085fc.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
MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, AND AMPHETAMINE SULFATE	Takeda Pharmaceuticals America, Inc.	141a7970-3f06-44ea-9ab7-aeece2c085fc	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022063 application number: NDA022063 ndc (product): 54092-471

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
O1ZPV620O4	AMPHETAMINE ASPARTATE MONOHYDRATE	851591-76-9	AMPHETAMINE ASPARTATE MONOHYDRATE
6DPV8NK46S	AMPHETAMINE SULFATE	60-13-9	AMPHETAMINE SULFATE
G83415V073	DEXTROAMPHETAMINE SACCHARATE	350708-40-6	DEXTROAMPHETAMINE SACCHARATE
JJ768O327N	DEXTROAMPHETAMINE SULFATE	51-63-8	DEXTROAMPHETAMINE SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1927610	amphetamine aspartate 12.5 MG / amphetamine sulfate 12.5 MG / dextroamphetamine saccharate 12.5 MG / dextroamphetamine sulfate 12.5 MG 3-Bead 24HR Extended Release Oral Capsule	PSN	141a7970-3f06-44ea-9ab7-aeece2c085fc	13
1927630	amphetamine aspartate 3.125 MG / amphetamine sulfate 3.125 MG / dextroamphetamine saccharate 3.125 MG / dextroamphetamine sulfate 3.125 MG 3-Bead 24HR Extended Release Oral Capsule	PSN	141a7970-3f06-44ea-9ab7-aeece2c085fc	13
1927617	amphetamine aspartate 6.25 MG / amphetamine sulfate 6.25 MG / dextroamphetamine saccharate 6.25 MG / dextroamphetamine sulfate 6.25 MG 3-Bead 24HR Extended Release Oral Capsule	PSN	141a7970-3f06-44ea-9ab7-aeece2c085fc	13
1927637	amphetamine aspartate 9.375 MG / amphetamine sulfate 9.375 MG / dextroamphetamine saccharate 9.375 MG / dextroamphetamine sulfate 9.375 MG 3-Bead 24HR Extended Release Oral Capsule	PSN	141a7970-3f06-44ea-9ab7-aeece2c085fc	13
1927632	Mydayis 12.5 MG 24HR Extended Release Oral Capsule	PSN	141a7970-3f06-44ea-9ab7-aeece2c085fc	13
1927619	Mydayis 25 MG 24HR Extended Release Oral Capsule	PSN	141a7970-3f06-44ea-9ab7-aeece2c085fc	13
1927639	Mydayis 37.5 MG 24HR Extended Release Oral Capsule	PSN	141a7970-3f06-44ea-9ab7-aeece2c085fc	13
1927616	Mydayis 50 MG 24HR Extended Release Oral Capsule	PSN	141a7970-3f06-44ea-9ab7-aeece2c085fc	13
1927616	3-Bead 24 HR amphetamine aspartate 12.5 MG / amphetamine sulfate 12.5 MG / dextroamphetamine saccharate 12.5 MG / dextroamphetamine sulfate 12.5 MG Extended Release Oral Capsule [Mydayis]	SBD	141a7970-3f06-44ea-9ab7-aeece2c085fc	13
1927632	3-Bead 24 HR amphetamine aspartate 3.125 MG / amphetamine sulfate 3.125 MG / dextroamphetamine saccharate 3.125 MG / dextroamphetamine sulfate 3.125 MG Extended Release Oral Capsule [Mydayis]	SBD	141a7970-3f06-44ea-9ab7-aeece2c085fc	13
1927619	3-Bead 24 HR amphetamine aspartate 6.25 MG / amphetamine sulfate 6.25 MG / dextroamphetamine saccharate 6.25 MG / dextroamphetamine sulfate 6.25 MG Extended Release Oral Capsule [Mydayis]	SBD	141a7970-3f06-44ea-9ab7-aeece2c085fc	13
1927639	3-Bead 24 HR amphetamine aspartate 9.375 MG / amphetamine sulfate 9.375 MG / dextroamphetamine saccharate 9.375 MG / dextroamphetamine sulfate 9.375 MG Extended Release Oral Capsule [Mydayis]	SBD	141a7970-3f06-44ea-9ab7-aeece2c085fc	13
1927610	3-Bead 24 HR amphetamine aspartate 12.5 MG / amphetamine sulfate 12.5 MG / dextroamphetamine saccharate 12.5 MG / dextroamphetamine sulfate 12.5 MG Extended Release Oral Capsule	SCD	141a7970-3f06-44ea-9ab7-aeece2c085fc	13
1927630	3-Bead 24 HR amphetamine aspartate 3.125 MG / amphetamine sulfate 3.125 MG / dextroamphetamine saccharate 3.125 MG / dextroamphetamine sulfate 3.125 MG Extended Release Oral Capsule	SCD	141a7970-3f06-44ea-9ab7-aeece2c085fc	13
1927617	3-Bead 24 HR amphetamine aspartate 6.25 MG / amphetamine sulfate 6.25 MG / dextroamphetamine saccharate 6.25 MG / dextroamphetamine sulfate 6.25 MG Extended Release Oral Capsule	SCD	141a7970-3f06-44ea-9ab7-aeece2c085fc	13
1927637	3-Bead 24 HR amphetamine aspartate 9.375 MG / amphetamine sulfate 9.375 MG / dextroamphetamine saccharate 9.375 MG / dextroamphetamine sulfate 9.375 MG Extended Release Oral Capsule	SCD	141a7970-3f06-44ea-9ab7-aeece2c085fc	13
1927610	amphetamine aspartate 12.5 MG / amphetamine sulfate 12.5 MG / dextroamphetamine saccharate 12.5 MG / dextroamphetamine sulfate 12.5 MG 3-Bead 24HR Extended Release Oral Capsule	SY	141a7970-3f06-44ea-9ab7-aeece2c085fc	13
1927630	amphetamine aspartate 3.125 MG / amphetamine sulfate 3.125 MG / dextroamphetamine saccharate 3.125 MG / dextroamphetamine sulfate 3.125 MG 3-Bead 24HR Extended Release Oral Capsule	SY	141a7970-3f06-44ea-9ab7-aeece2c085fc	13
1927617	amphetamine aspartate 6.25 MG / amphetamine sulfate 6.25 MG / dextroamphetamine saccharate 6.25 MG / dextroamphetamine sulfate 6.25 MG 3-Bead 24HR Extended Release Oral Capsule	SY	141a7970-3f06-44ea-9ab7-aeece2c085fc	13
1927637	amphetamine aspartate 9.375 MG / amphetamine sulfate 9.375 MG / dextroamphetamine saccharate 9.375 MG / dextroamphetamine sulfate 9.375 MG 3-Bead 24HR Extended Release Oral Capsule	SY	141a7970-3f06-44ea-9ab7-aeece2c085fc	13
1927632	Mydayis 12.5 MG 24HR Extended Release Oral Capsule	SY	141a7970-3f06-44ea-9ab7-aeece2c085fc	13
1927619	Mydayis 25 MG 24HR Extended Release Oral Capsule	SY	141a7970-3f06-44ea-9ab7-aeece2c085fc	13
1927639	Mydayis 37.5 MG 24HR Extended Release Oral Capsule	SY	141a7970-3f06-44ea-9ab7-aeece2c085fc	13
1927616	Mydayis 50 MG 24HR Extended Release Oral Capsule	SY	141a7970-3f06-44ea-9ab7-aeece2c085fc	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
54092-471-01	54092047101	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-471-01)	2017-06-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MYDAYIS	Takeda Pharmaceuticals America, Inc. \| Cambrex Charles City, Inc \| Patheon Manufacturing Services LLC	2026-04-30	HUMAN PRESCRIPTION DRUG LABEL	13