Vyvanse

Product NDC: 59417-102
11-digit product format: 594170102
Labeler code: 59417
Product ID: 59417-102_81d087b6-4cb4-466a-9693-679edeb062e2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lisdexamfetamine dimesylate
Dosage form: CAPSULE
Route: ORAL
Labeler: Takeda Pharmaceuticals America, Inc.
Application: NDA021977
Marketing category: NDA
Marketing start: 2007-12-10
Substance: LISDEXAMFETAMINE DIMESYLATE
Active strength: 20 mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC], 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 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021977-001	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	30MG	CAPSULE / ORAL	AB	RLD	2007-02-23
N021977-002	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	50MG	CAPSULE / ORAL	AB	RLD	2007-02-23
N021977-003	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	70MG	CAPSULE / ORAL	AB	RLD, RS	2007-02-23
N021977-004	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	20MG	CAPSULE / ORAL	AB	RLD	2007-12-10
N021977-005	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	40MG	CAPSULE / ORAL	AB	RLD	2007-12-10
N021977-006	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	60MG	CAPSULE / ORAL	AB	RLD	2007-12-10
N021977-007	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	10MG	CAPSULE / ORAL	AB	RLD	2014-10-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-product	TE code
N021977-001	AB
N021977-002	AB
N021977-003	AB
N021977-004	AB
N021977-005	AB
N021977-006	AB
N021977-007	AB

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 8 · 287 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	N021977-001	VYVANSE	30MG	CAPSULE / ORAL	AB	RLD	2007-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021977-002	VYVANSE	50MG	CAPSULE / ORAL	AB	RLD	2007-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021977-003	VYVANSE	70MG	CAPSULE / ORAL	AB	RLD, RS	2007-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021977-004	VYVANSE	20MG	CAPSULE / ORAL	AB	RLD	2007-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021977-005	VYVANSE	40MG	CAPSULE / ORAL	AB	RLD	2007-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021977-006	VYVANSE	60MG	CAPSULE / ORAL	AB	RLD	2007-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021977-007	VYVANSE	10MG	CAPSULE / ORAL	AB	RLD	2014-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021977-001	VYVANSE	30MG	CAPSULE / ORAL	AB	RLD	2007-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021977-002	VYVANSE	50MG	CAPSULE / ORAL	AB	RLD	2007-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021977-003	VYVANSE	70MG	CAPSULE / ORAL	AB	RLD, RS	2007-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021977-004	VYVANSE	20MG	CAPSULE / ORAL	AB	RLD	2007-12-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021977-005	VYVANSE	40MG	CAPSULE / ORAL	AB	RLD	2007-12-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021977-006	VYVANSE	60MG	CAPSULE / ORAL	AB	RLD	2007-12-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021977-007	VYVANSE	10MG	CAPSULE / ORAL	AB	RLD	2014-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021977-001	VYVANSE	30MG	CAPSULE / ORAL	AB	RLD	2007-02-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021977-002	VYVANSE	50MG	CAPSULE / ORAL	AB	RLD	2007-02-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021977-003	VYVANSE	70MG	CAPSULE / ORAL	AB	RLD, RS	2007-02-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021977-004	VYVANSE	20MG	CAPSULE / ORAL	AB	RLD	2007-12-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021977-005	VYVANSE	40MG	CAPSULE / ORAL	AB	RLD	2007-12-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021977-006	VYVANSE	60MG	CAPSULE / ORAL	AB	RLD	2007-12-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021977-007	VYVANSE	10MG	CAPSULE / ORAL	AB	RLD	2014-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021977-001	VYVANSE	30MG	CAPSULE / ORAL	AB	RLD	2007-02-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021977-002	VYVANSE	50MG	CAPSULE / ORAL	AB	RLD	2007-02-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021977-003	VYVANSE	70MG	CAPSULE / ORAL	AB	RLD, RS	2007-02-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021977-004	VYVANSE	20MG	CAPSULE / ORAL	AB	RLD	2007-12-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021977-005	VYVANSE	40MG	CAPSULE / ORAL	AB	RLD	2007-12-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021977-006	VYVANSE	60MG	CAPSULE / ORAL	AB	RLD	2007-12-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021977-007	VYVANSE	10MG	CAPSULE / ORAL	AB	RLD	2014-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021977-001	VYVANSE	30MG	CAPSULE / ORAL	AB	RLD	2007-02-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021977-002	VYVANSE	50MG	CAPSULE / ORAL	AB	RLD	2007-02-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021977-003	VYVANSE	70MG	CAPSULE / ORAL	AB	RLD, RS	2007-02-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021977-004	VYVANSE	20MG	CAPSULE / ORAL	AB	RLD	2007-12-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021977-005	VYVANSE	40MG	CAPSULE / ORAL	AB	RLD	2007-12-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021977-006	VYVANSE	60MG	CAPSULE / ORAL	AB	RLD	2007-12-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021977-007	VYVANSE	10MG	CAPSULE / ORAL	AB	RLD	2014-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021977-001	VYVANSE	30MG	CAPSULE / ORAL	AB	RLD	2007-02-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021977-002	VYVANSE	50MG	CAPSULE / ORAL	AB	RLD	2007-02-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021977-003	VYVANSE	70MG	CAPSULE / ORAL	AB	RLD, RS	2007-02-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021977-004	VYVANSE	20MG	CAPSULE / ORAL	AB	RLD	2007-12-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021977-005	VYVANSE	40MG	CAPSULE / ORAL	AB	RLD	2007-12-10	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 140 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	N021977-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021977-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021977-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021977-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021977-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021977-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021977-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021977-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021977-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021977-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021977-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021977-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021977-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021977-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021977-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021977-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021977-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021977-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021977-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021977-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021977-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021977-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021977-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021977-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021977-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021977-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021977-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021977-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021977-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021977-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021977-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021977-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021977-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021977-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021977-007	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021977-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021977-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021977-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021977-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021977-005	AB	1	`03ed91905a0d…`

Observed Orange Book patent history#

Patent history page 1 of 126 · 5,002 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7105486	2023-02-24	U-727			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7223735	2023-02-24		Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7655630	2023-02-24		Drug substance		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7659253	2023-02-24	U-727	Drug substance, Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7659254	2023-02-24	U-1034			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7662787	2023-02-24		Drug substance		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7662788	2023-02-24	U-727		2012-02-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7671030	2023-02-24	U-727	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7671031	2023-02-24	U-727			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7674774	2023-02-24	U-842	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7678770	2023-02-24	U-842			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7678771	2023-02-24	U-842	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7687466	2023-02-24		Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7687467	2023-02-24	U-842	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7700561	2023-02-24		Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7713936	2023-02-24	U-727		2012-02-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7718619	2023-02-24	U-842	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7723305	2023-02-24	U-842	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7105486*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7223735*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7655630*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7659253*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7659254*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7662787*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7662788*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7671030*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7671031*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7674774*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7678770*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7678771*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7687466*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7687467*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7700561*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7713936*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7718619*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7723305*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-002	7105486	2023-02-24	U-727			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-002	7223735	2023-02-24		Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-002	7655630	2023-02-24		Drug substance		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-002	7659253	2023-02-24	U-727	Drug substance, Drug product		`5c6f7cd8ea54…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021977-001	M-188	2019-10-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021977-002	M-188	2019-10-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021977-003	M-188	2019-10-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021977-004	M-188	2019-10-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021977-005	M-188	2019-10-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021977-006	M-188	2019-10-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021977-007	M-188	2019-10-14	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021977-001	M-188	2019-10-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021977-002	M-188	2019-10-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021977-003	M-188	2019-10-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021977-004	M-188	2019-10-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021977-005	M-188	2019-10-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021977-006	M-188	2019-10-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021977-007	M-188	2019-10-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021977-001	M-188	2019-10-14	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021977-002	M-188	2019-10-14	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021977-003	M-188	2019-10-14	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021977-004	M-188	2019-10-14	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021977-005	M-188	2019-10-14	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021977-006	M-188	2019-10-14	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021977-007	M-188	2019-10-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021977-001	M-188	2019-10-14	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021977-002	M-188	2019-10-14	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021977-003	M-188	2019-10-14	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021977-004	M-188	2019-10-14	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021977-005	M-188	2019-10-14	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021977-006	M-188	2019-10-14	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021977-007	M-188	2019-10-14	`ea99ee380514…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LISDEXAMFETAMINE DIMESYLATE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SJT761GEGS	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 2 · 26 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
854830	Internal RxNorm lookup
854832	Internal RxNorm lookup
854834	Internal RxNorm lookup
854836	Internal RxNorm lookup
854838	Internal RxNorm lookup
854840	Internal RxNorm lookup
854842	Internal RxNorm lookup
854844	Internal RxNorm lookup
854846	Internal RxNorm lookup
854848	Internal RxNorm lookup
854850	Internal RxNorm lookup
854852	Internal RxNorm lookup
1593856	Internal RxNorm lookup
1593858	Internal RxNorm lookup
1871456	Internal RxNorm lookup
1871459	Internal RxNorm lookup
1871460	Internal RxNorm lookup
1871461	Internal RxNorm lookup
1871462	Internal RxNorm lookup
1871463	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
704e4378-ca83-445c-8b45-3cfa51c1ecad	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cb29ac3a-860f-7ed2-7559-c97af4af1704	Product name	3	20250603

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59417-102-10	Vyvanse	100 in 1 BOTTLE	CAPSULE	100		81

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59417-102-10	EA - Each	59417-102	209de0be-323b-47db-aea3-a0d06b75e061	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LISDEXAMFETAMINE DIMESYLATE	ACTIVE INGREDIENT	SJT761GEGS	VYVANSE (LISDEXAMFETAMINE DIMESYLATE) CAPSULE [SHIRE LLC]	54
LISDEXAMFETAMINE	ACTIVE MOIETY	H645GUL8KJ	VYVANSE (LISDEXAMFETAMINE DIMESYLATE) CAPSULE [SHIRE LLC]	54
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	VYVANSE (LISDEXAMFETAMINE DIMESYLATE) CAPSULE [SHIRE LLC]	54
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	VYVANSE (LISDEXAMFETAMINE DIMESYLATE) CAPSULE [SHIRE LLC]	54
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	VYVANSE (LISDEXAMFETAMINE DIMESYLATE) CAPSULE [SHIRE LLC]	54
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	VYVANSE (LISDEXAMFETAMINE DIMESYLATE) CAPSULE [SHIRE LLC]	54
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	VYVANSE (LISDEXAMFETAMINE DIMESYLATE) CAPSULE [SHIRE LLC]	54
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	VYVANSE (LISDEXAMFETAMINE DIMESYLATE) CAPSULE [SHIRE LLC]	54
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	VYVANSE (LISDEXAMFETAMINE DIMESYLATE) CAPSULE [SHIRE LLC]	54
GELATIN	INACTIVE INGREDIENT	2G86QN327L	VYVANSE (LISDEXAMFETAMINE DIMESYLATE) CAPSULE [SHIRE LLC]	54
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	VYVANSE (LISDEXAMFETAMINE DIMESYLATE) CAPSULE [SHIRE LLC]	54
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	VYVANSE (LISDEXAMFETAMINE DIMESYLATE) CAPSULE [SHIRE LLC]	54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59417-102	VYVANSE (LISDEXAMFETAMINE DIMESYLATE) CAPSULE VYVANSE (LISDEXAMFETAMINE DIMESYLATE) TABLET, CHEWABLE [TAKEDA PHARMACEUTICALS AMERICA, INC.]	75	Current NDC, Legacy NDC, 1 package rows	20231024_704e4378-ca83-445c-8b45-3cfa51c1ecad.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
Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Takeda Pharmaceuticals America, Inc.	704e4378-ca83-445c-8b45-3cfa51c1ecad	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021977 application number: NDA021977 ndc (product): 59417-102

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SJT761GEGS	LISDEXAMFETAMINE DIMESYLATE	608137-33-3	LISDEXAMFETAMINE DIMESYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1871464	lisdexamfetamine dimesylate 10 MG Chewable Tablet	PSN	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
1593856	lisdexamfetamine dimesylate 10 MG Oral Capsule	PSN	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
1871462	lisdexamfetamine dimesylate 20 MG Chewable Tablet	PSN	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
854830	lisdexamfetamine dimesylate 20 MG Oral Capsule	PSN	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
1871460	lisdexamfetamine dimesylate 30 MG Chewable Tablet	PSN	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
854834	lisdexamfetamine dimesylate 30 MG Oral Capsule	PSN	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
1871456	lisdexamfetamine dimesylate 40 MG Chewable Tablet	PSN	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
854838	lisdexamfetamine dimesylate 40 MG Oral Capsule	PSN	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
1871468	lisdexamfetamine dimesylate 50 MG Chewable Tablet	PSN	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
854850	lisdexamfetamine dimesylate 50 MG Oral Capsule	PSN	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
1871466	lisdexamfetamine dimesylate 60 MG Chewable Tablet	PSN	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
854846	lisdexamfetamine dimesylate 60 MG Oral Capsule	PSN	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
854842	lisdexamfetamine dimesylate 70 MG Oral Capsule	PSN	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
1871465	Vyvanse 10 MG Chewable Tablet	PSN	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
1593858	Vyvanse 10 MG Oral Capsule	PSN	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
1871463	Vyvanse 20 MG Chewable Tablet	PSN	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
854832	Vyvanse 20 MG Oral Capsule	PSN	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
1871461	Vyvanse 30 MG Chewable Tablet	PSN	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
854836	Vyvanse 30 MG Oral Capsule	PSN	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
1871459	Vyvanse 40 MG Chewable Tablet	PSN	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
854840	Vyvanse 40 MG Oral Capsule	PSN	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
1871469	Vyvanse 50 MG Chewable Tablet	PSN	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
854852	Vyvanse 50 MG Oral Capsule	PSN	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
1871467	Vyvanse 60 MG Chewable Tablet	PSN	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
854848	Vyvanse 60 MG Oral Capsule	PSN	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
854844	Vyvanse 70 MG Oral Capsule	PSN	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
1871465	lisdexamfetamine dimesylate 10 MG Chewable Tablet [Vyvanse]	SBD	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
1593858	lisdexamfetamine dimesylate 10 MG Oral Capsule [Vyvanse]	SBD	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
1871463	lisdexamfetamine dimesylate 20 MG Chewable Tablet [Vyvanse]	SBD	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
854832	lisdexamfetamine dimesylate 20 MG Oral Capsule [Vyvanse]	SBD	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
1871461	lisdexamfetamine dimesylate 30 MG Chewable Tablet [Vyvanse]	SBD	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
854836	lisdexamfetamine dimesylate 30 MG Oral Capsule [Vyvanse]	SBD	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
1871459	lisdexamfetamine dimesylate 40 MG Chewable Tablet [Vyvanse]	SBD	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
854840	lisdexamfetamine dimesylate 40 MG Oral Capsule [Vyvanse]	SBD	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
1871469	lisdexamfetamine dimesylate 50 MG Chewable Tablet [Vyvanse]	SBD	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
854852	lisdexamfetamine dimesylate 50 MG Oral Capsule [Vyvanse]	SBD	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
1871467	lisdexamfetamine dimesylate 60 MG Chewable Tablet [Vyvanse]	SBD	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
854848	lisdexamfetamine dimesylate 60 MG Oral Capsule [Vyvanse]	SBD	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
854844	lisdexamfetamine dimesylate 70 MG Oral Capsule [Vyvanse]	SBD	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
1871464	lisdexamfetamine dimesylate 10 MG Chewable Tablet	SCD	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
1593856	lisdexamfetamine dimesylate 10 MG Oral Capsule	SCD	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
1871462	lisdexamfetamine dimesylate 20 MG Chewable Tablet	SCD	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
854830	lisdexamfetamine dimesylate 20 MG Oral Capsule	SCD	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
1871460	lisdexamfetamine dimesylate 30 MG Chewable Tablet	SCD	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
854834	lisdexamfetamine dimesylate 30 MG Oral Capsule	SCD	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
1871456	lisdexamfetamine dimesylate 40 MG Chewable Tablet	SCD	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
854838	lisdexamfetamine dimesylate 40 MG Oral Capsule	SCD	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
1871468	lisdexamfetamine dimesylate 50 MG Chewable Tablet	SCD	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
854850	lisdexamfetamine dimesylate 50 MG Oral Capsule	SCD	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
1871466	lisdexamfetamine dimesylate 60 MG Chewable Tablet	SCD	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
854846	lisdexamfetamine dimesylate 60 MG Oral Capsule	SCD	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
854842	lisdexamfetamine dimesylate 70 MG Oral Capsule	SCD	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
1871465	Vyvanse 10 MG Chewable Tablet	SY	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
1593858	Vyvanse 10 MG Oral Capsule	SY	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
1871463	Vyvanse 20 MG Chewable Tablet	SY	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
854832	Vyvanse 20 MG Oral Capsule	SY	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
1871461	Vyvanse 30 MG Chewable Tablet	SY	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
854836	Vyvanse 30 MG Oral Capsule	SY	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
1871459	Vyvanse 40 MG Chewable Tablet	SY	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
854840	Vyvanse 40 MG Oral Capsule	SY	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
1871469	Vyvanse 50 MG Chewable Tablet	SY	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
854852	Vyvanse 50 MG Oral Capsule	SY	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
1871467	Vyvanse 60 MG Chewable Tablet	SY	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
854848	Vyvanse 60 MG Oral Capsule	SY	704e4378-ca83-445c-8b45-3cfa51c1ecad	81
854844	Vyvanse 70 MG Oral Capsule	SY	704e4378-ca83-445c-8b45-3cfa51c1ecad	81

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59417-102-10	59417010210	100 CAPSULE in 1 BOTTLE (59417-102-10)	100 capsule	2007-12-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Vyvanse	Takeda Pharmaceuticals America, Inc. \| Curia New York, Inc. \| Cambrex Charles City, Inc \| Patheon Manufacturing Services LLC \| Patheon Pharmaceuticals Inc. \| Sharp Packaging Services, LLC	2026-04-30	HUMAN PRESCRIPTION DRUG LABEL	81