Lisdexamfetamine Dimesylate

Product NDC: 42291-037
11-digit product format: 422910037
Labeler code: 42291
Product ID: 42291-037_36c401bd-e228-6fbd-e063-6394a90a5f1f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lisdexamfetamine
Dosage form: CAPSULE
Route: ORAL
Labeler: AvKARE
Application: ANDA202830
Marketing category: ANDA
Marketing start: 2025-06-04
Substance: LISDEXAMFETAMINE DIMESYLATE
Active strength: 30 mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202830-001	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	20MG	CAPSULE / ORAL	AB	2023-08-25
A202830-002	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	30MG	CAPSULE / ORAL	AB	2023-08-25
A202830-003	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	40MG	CAPSULE / ORAL	AB	2023-08-25
A202830-004	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	50MG	CAPSULE / ORAL	AB	2023-08-25
A202830-005	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	60MG	CAPSULE / ORAL	AB	2023-08-25
A202830-006	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	70MG	CAPSULE / ORAL	AB	2023-08-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A202830-001	AB
A202830-002	AB
A202830-003	AB
A202830-004	AB
A202830-005	AB
A202830-006	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 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202830-001	LISDEXAMFETAMINE DIMESYLATE	20MG	CAPSULE / ORAL	AB	2023-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202830-002	LISDEXAMFETAMINE DIMESYLATE	30MG	CAPSULE / ORAL	AB	2023-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202830-003	LISDEXAMFETAMINE DIMESYLATE	40MG	CAPSULE / ORAL	AB	2023-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202830-004	LISDEXAMFETAMINE DIMESYLATE	50MG	CAPSULE / ORAL	AB	2023-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202830-005	LISDEXAMFETAMINE DIMESYLATE	60MG	CAPSULE / ORAL	AB	2023-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202830-006	LISDEXAMFETAMINE DIMESYLATE	70MG	CAPSULE / ORAL	AB	2023-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202830-001	LISDEXAMFETAMINE DIMESYLATE	20MG	CAPSULE / ORAL	AB	2023-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202830-002	LISDEXAMFETAMINE DIMESYLATE	30MG	CAPSULE / ORAL	AB	2023-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202830-003	LISDEXAMFETAMINE DIMESYLATE	40MG	CAPSULE / ORAL	AB	2023-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202830-004	LISDEXAMFETAMINE DIMESYLATE	50MG	CAPSULE / ORAL	AB	2023-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202830-005	LISDEXAMFETAMINE DIMESYLATE	60MG	CAPSULE / ORAL	AB	2023-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202830-006	LISDEXAMFETAMINE DIMESYLATE	70MG	CAPSULE / ORAL	AB	2023-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202830-001	LISDEXAMFETAMINE DIMESYLATE	20MG	CAPSULE / ORAL	AB	2023-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202830-002	LISDEXAMFETAMINE DIMESYLATE	30MG	CAPSULE / ORAL	AB	2023-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202830-003	LISDEXAMFETAMINE DIMESYLATE	40MG	CAPSULE / ORAL	AB	2023-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202830-004	LISDEXAMFETAMINE DIMESYLATE	50MG	CAPSULE / ORAL	AB	2023-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202830-005	LISDEXAMFETAMINE DIMESYLATE	60MG	CAPSULE / ORAL	AB	2023-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202830-006	LISDEXAMFETAMINE DIMESYLATE	70MG	CAPSULE / ORAL	AB	2023-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202830-001	LISDEXAMFETAMINE DIMESYLATE	20MG	CAPSULE / ORAL	AB	2023-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202830-002	LISDEXAMFETAMINE DIMESYLATE	30MG	CAPSULE / ORAL	AB	2023-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202830-003	LISDEXAMFETAMINE DIMESYLATE	40MG	CAPSULE / ORAL	AB	2023-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202830-004	LISDEXAMFETAMINE DIMESYLATE	50MG	CAPSULE / ORAL	AB	2023-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202830-005	LISDEXAMFETAMINE DIMESYLATE	60MG	CAPSULE / ORAL	AB	2023-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202830-006	LISDEXAMFETAMINE DIMESYLATE	70MG	CAPSULE / ORAL	AB	2023-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202830-001	LISDEXAMFETAMINE DIMESYLATE	20MG	CAPSULE / ORAL	AB	2023-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202830-002	LISDEXAMFETAMINE DIMESYLATE	30MG	CAPSULE / ORAL	AB	2023-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202830-003	LISDEXAMFETAMINE DIMESYLATE	40MG	CAPSULE / ORAL	AB	2023-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202830-004	LISDEXAMFETAMINE DIMESYLATE	50MG	CAPSULE / ORAL	AB	2023-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202830-005	LISDEXAMFETAMINE DIMESYLATE	60MG	CAPSULE / ORAL	AB	2023-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202830-006	LISDEXAMFETAMINE DIMESYLATE	70MG	CAPSULE / ORAL	AB	2023-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202830-001	LISDEXAMFETAMINE DIMESYLATE	20MG	CAPSULE / ORAL	AB	2023-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202830-002	LISDEXAMFETAMINE DIMESYLATE	30MG	CAPSULE / ORAL	AB	2023-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202830-003	LISDEXAMFETAMINE DIMESYLATE	40MG	CAPSULE / ORAL	AB	2023-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202830-004	LISDEXAMFETAMINE DIMESYLATE	50MG	CAPSULE / ORAL	AB	2023-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202830-005	LISDEXAMFETAMINE DIMESYLATE	60MG	CAPSULE / ORAL	AB	2023-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202830-006	LISDEXAMFETAMINE DIMESYLATE	70MG	CAPSULE / ORAL	AB	2023-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202830-001	LISDEXAMFETAMINE DIMESYLATE	20MG	CAPSULE / ORAL	AB	2023-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202830-002	LISDEXAMFETAMINE DIMESYLATE	30MG	CAPSULE / ORAL	AB	2023-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202830-003	LISDEXAMFETAMINE DIMESYLATE	40MG	CAPSULE / ORAL	AB	2023-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202830-004	LISDEXAMFETAMINE DIMESYLATE	50MG	CAPSULE / ORAL	AB	2023-08-25	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 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	A202830-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202830-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202830-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202830-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202830-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202830-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202830-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202830-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202830-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202830-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202830-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202830-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202830-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202830-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202830-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202830-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202830-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202830-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202830-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202830-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202830-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202830-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202830-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202830-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202830-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202830-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202830-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202830-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202830-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202830-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202830-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202830-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202830-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202830-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202830-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202830-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202830-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202830-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202830-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202830-004	AB	1	`2680178bc6a6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Lisdexamfetamine Dimesylate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LISDEXAMFETAMINE DIMESYLATE	30 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 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
854830	Internal RxNorm lookup
854834	Internal RxNorm lookup
854838	Internal RxNorm lookup
854842	Internal RxNorm lookup
854846	Internal RxNorm lookup
854850	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
36c40404-fe94-6fb7-e063-6394a90a2657	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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42291-037-90	Lisdexamfetamine Dimesylate	90 in 1 BOTTLE	CAPSULE	90		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-037-90	EA - Each	42291-037	d567ebc4-237f-47dc-b370-847f564fa780	1	2025-07-08

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
Lisdexamfetamine Dimesylate	LISDEXAMFETAMINE	Amneal Pharmaceuticals LLC	c11cb3b6-3dff-477b-a249-b4c3118edc5f	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202830 application number: ANDA202830
Lisdexamfetamine Dimesylate	LISDEXAMFETAMINE	AvKARE	36c40404-fe94-6fb7-e063-6394a90a2657	2025-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202830 application number: ANDA202830 ndc (product): 42291-037

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SJT761GEGS	LISDEXAMFETAMINE DIMESYLATE	608137-33-3	LISDEXAMFETAMINE DIMESYLATE
H645GUL8KJ	LISDEXAMFETAMINE	608137-32-2	Lisdexamfetamine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
854830	lisdexamfetamine dimesylate 20 MG Oral Capsule	PSN	36c40404-fe94-6fb7-e063-6394a90a2657	1
854834	lisdexamfetamine dimesylate 30 MG Oral Capsule	PSN	36c40404-fe94-6fb7-e063-6394a90a2657	1
854838	lisdexamfetamine dimesylate 40 MG Oral Capsule	PSN	36c40404-fe94-6fb7-e063-6394a90a2657	1
854850	lisdexamfetamine dimesylate 50 MG Oral Capsule	PSN	36c40404-fe94-6fb7-e063-6394a90a2657	1
854846	lisdexamfetamine dimesylate 60 MG Oral Capsule	PSN	36c40404-fe94-6fb7-e063-6394a90a2657	1
854842	lisdexamfetamine dimesylate 70 MG Oral Capsule	PSN	36c40404-fe94-6fb7-e063-6394a90a2657	1
854830	lisdexamfetamine dimesylate 20 MG Oral Capsule	SCD	36c40404-fe94-6fb7-e063-6394a90a2657	1
854834	lisdexamfetamine dimesylate 30 MG Oral Capsule	SCD	36c40404-fe94-6fb7-e063-6394a90a2657	1
854838	lisdexamfetamine dimesylate 40 MG Oral Capsule	SCD	36c40404-fe94-6fb7-e063-6394a90a2657	1
854850	lisdexamfetamine dimesylate 50 MG Oral Capsule	SCD	36c40404-fe94-6fb7-e063-6394a90a2657	1
854846	lisdexamfetamine dimesylate 60 MG Oral Capsule	SCD	36c40404-fe94-6fb7-e063-6394a90a2657	1
854842	lisdexamfetamine dimesylate 70 MG Oral Capsule	SCD	36c40404-fe94-6fb7-e063-6394a90a2657	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
42291-037-90	42291003790	90 CAPSULE in 1 BOTTLE (42291-037-90)	90 capsule	2025-06-04	No	No	Current