Lisdexamfetamine Dimesylate

Product NDC: 64850-555
11-digit product format: 648500555
Labeler code: 64850
Product ID: 64850-555_81cfbfd5-71c0-4c39-bcf3-2eae9fbd48fa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lisdexamfetamine dimesylate
Dosage form: CAPSULE
Route: ORAL
Labeler: Elite Laboratories, Inc.
Application: ANDA218604
Marketing category: ANDA
Marketing start: 2024-11-15
Substance: LISDEXAMFETAMINE DIMESYLATE
Active strength: 60 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 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A218604-001	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	10MG	CAPSULE / ORAL	AB	2024-11-15
A218604-002	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	20MG	CAPSULE / ORAL	AB	2024-11-15
A218604-003	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	30MG	CAPSULE / ORAL	AB	2024-11-15
A218604-004	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	40MG	CAPSULE / ORAL	AB	2024-11-15
A218604-005	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	50MG	CAPSULE / ORAL	AB	2024-11-15
A218604-006	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	60MG	CAPSULE / ORAL	AB	2024-11-15
A218604-007	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	70MG	CAPSULE / ORAL	AB	2024-11-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218604-001	AB
A218604-002	AB
A218604-003	AB
A218604-004	AB
A218604-005	AB
A218604-006	AB
A218604-007	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 2 · 56 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	A218604-001	LISDEXAMFETAMINE DIMESYLATE	10MG	CAPSULE / ORAL	AB	2024-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218604-002	LISDEXAMFETAMINE DIMESYLATE	20MG	CAPSULE / ORAL	AB	2024-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218604-003	LISDEXAMFETAMINE DIMESYLATE	30MG	CAPSULE / ORAL	AB	2024-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218604-004	LISDEXAMFETAMINE DIMESYLATE	40MG	CAPSULE / ORAL	AB	2024-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218604-005	LISDEXAMFETAMINE DIMESYLATE	50MG	CAPSULE / ORAL	AB	2024-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218604-006	LISDEXAMFETAMINE DIMESYLATE	60MG	CAPSULE / ORAL	AB	2024-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218604-007	LISDEXAMFETAMINE DIMESYLATE	70MG	CAPSULE / ORAL	AB	2024-11-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218604-001	LISDEXAMFETAMINE DIMESYLATE	10MG	CAPSULE / ORAL	AB	2024-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218604-002	LISDEXAMFETAMINE DIMESYLATE	20MG	CAPSULE / ORAL	AB	2024-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218604-003	LISDEXAMFETAMINE DIMESYLATE	30MG	CAPSULE / ORAL	AB	2024-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218604-004	LISDEXAMFETAMINE DIMESYLATE	40MG	CAPSULE / ORAL	AB	2024-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218604-005	LISDEXAMFETAMINE DIMESYLATE	50MG	CAPSULE / ORAL	AB	2024-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218604-006	LISDEXAMFETAMINE DIMESYLATE	60MG	CAPSULE / ORAL	AB	2024-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218604-007	LISDEXAMFETAMINE DIMESYLATE	70MG	CAPSULE / ORAL	AB	2024-11-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218604-001	LISDEXAMFETAMINE DIMESYLATE	10MG	CAPSULE / ORAL	AB	2024-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218604-002	LISDEXAMFETAMINE DIMESYLATE	20MG	CAPSULE / ORAL	AB	2024-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218604-003	LISDEXAMFETAMINE DIMESYLATE	30MG	CAPSULE / ORAL	AB	2024-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218604-004	LISDEXAMFETAMINE DIMESYLATE	40MG	CAPSULE / ORAL	AB	2024-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218604-005	LISDEXAMFETAMINE DIMESYLATE	50MG	CAPSULE / ORAL	AB	2024-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218604-006	LISDEXAMFETAMINE DIMESYLATE	60MG	CAPSULE / ORAL	AB	2024-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218604-007	LISDEXAMFETAMINE DIMESYLATE	70MG	CAPSULE / ORAL	AB	2024-11-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218604-001	LISDEXAMFETAMINE DIMESYLATE	10MG	CAPSULE / ORAL	AB	2024-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218604-002	LISDEXAMFETAMINE DIMESYLATE	20MG	CAPSULE / ORAL	AB	2024-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218604-003	LISDEXAMFETAMINE DIMESYLATE	30MG	CAPSULE / ORAL	AB	2024-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218604-004	LISDEXAMFETAMINE DIMESYLATE	40MG	CAPSULE / ORAL	AB	2024-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218604-005	LISDEXAMFETAMINE DIMESYLATE	50MG	CAPSULE / ORAL	AB	2024-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218604-006	LISDEXAMFETAMINE DIMESYLATE	60MG	CAPSULE / ORAL	AB	2024-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218604-007	LISDEXAMFETAMINE DIMESYLATE	70MG	CAPSULE / ORAL	AB	2024-11-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218604-001	LISDEXAMFETAMINE DIMESYLATE	10MG	CAPSULE / ORAL	AB	2024-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218604-002	LISDEXAMFETAMINE DIMESYLATE	20MG	CAPSULE / ORAL	AB	2024-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218604-003	LISDEXAMFETAMINE DIMESYLATE	30MG	CAPSULE / ORAL	AB	2024-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218604-004	LISDEXAMFETAMINE DIMESYLATE	40MG	CAPSULE / ORAL	AB	2024-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218604-005	LISDEXAMFETAMINE DIMESYLATE	50MG	CAPSULE / ORAL	AB	2024-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218604-006	LISDEXAMFETAMINE DIMESYLATE	60MG	CAPSULE / ORAL	AB	2024-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218604-007	LISDEXAMFETAMINE DIMESYLATE	70MG	CAPSULE / ORAL	AB	2024-11-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218604-001	LISDEXAMFETAMINE DIMESYLATE	10MG	CAPSULE / ORAL	AB	2024-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218604-002	LISDEXAMFETAMINE DIMESYLATE	20MG	CAPSULE / ORAL	AB	2024-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218604-003	LISDEXAMFETAMINE DIMESYLATE	30MG	CAPSULE / ORAL	AB	2024-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218604-004	LISDEXAMFETAMINE DIMESYLATE	40MG	CAPSULE / ORAL	AB	2024-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218604-005	LISDEXAMFETAMINE DIMESYLATE	50MG	CAPSULE / ORAL	AB	2024-11-15	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 56 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	A218604-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218604-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218604-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218604-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218604-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218604-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218604-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218604-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218604-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218604-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218604-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218604-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218604-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218604-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218604-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218604-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218604-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218604-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218604-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218604-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218604-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218604-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218604-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218604-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218604-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218604-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218604-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218604-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218604-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218604-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218604-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218604-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218604-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218604-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218604-007	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218604-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218604-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218604-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218604-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218604-005	AB	1	`03ed91905a0d…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LISDEXAMFETAMINE DIMESYLATE	60 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 · 7 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
1593856	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
0e024b69-567c-4b40-9c3e-a2daec34256c	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
64850-555-01	Lisdexamfetamine Dimesylate	100 in 1 BOTTLE	CAPSULE	100		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64850-555-01	EA - Each	64850-555	3052a86f-afdf-4859-a5c4-b2f37468be17	1	2025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64850-555	LISDEXAMFETAMINE DIMESYLATE CAPSULE [ELITE LABORATORIES, INC.]	4	Current NDC, 1 package rows	20241123_0e024b69-567c-4b40-9c3e-a2daec34256c.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
Lisdexamfetamine Dimesylate	LISDEXAMFETAMINE DIMESYLATE	Elite Laboratories, Inc.	0e024b69-567c-4b40-9c3e-a2daec34256c	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218604 application number: ANDA218604 ndc (product): 64850-555

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
1593856	lisdexamfetamine dimesylate 10 MG Oral Capsule	PSN	0e024b69-567c-4b40-9c3e-a2daec34256c	5
854830	lisdexamfetamine dimesylate 20 MG Oral Capsule	PSN	0e024b69-567c-4b40-9c3e-a2daec34256c	5
854834	lisdexamfetamine dimesylate 30 MG Oral Capsule	PSN	0e024b69-567c-4b40-9c3e-a2daec34256c	5
854838	lisdexamfetamine dimesylate 40 MG Oral Capsule	PSN	0e024b69-567c-4b40-9c3e-a2daec34256c	5
854850	lisdexamfetamine dimesylate 50 MG Oral Capsule	PSN	0e024b69-567c-4b40-9c3e-a2daec34256c	5
854846	lisdexamfetamine dimesylate 60 MG Oral Capsule	PSN	0e024b69-567c-4b40-9c3e-a2daec34256c	5
854842	lisdexamfetamine dimesylate 70 MG Oral Capsule	PSN	0e024b69-567c-4b40-9c3e-a2daec34256c	5
1593856	lisdexamfetamine dimesylate 10 MG Oral Capsule	SCD	0e024b69-567c-4b40-9c3e-a2daec34256c	5
854830	lisdexamfetamine dimesylate 20 MG Oral Capsule	SCD	0e024b69-567c-4b40-9c3e-a2daec34256c	5
854834	lisdexamfetamine dimesylate 30 MG Oral Capsule	SCD	0e024b69-567c-4b40-9c3e-a2daec34256c	5
854838	lisdexamfetamine dimesylate 40 MG Oral Capsule	SCD	0e024b69-567c-4b40-9c3e-a2daec34256c	5
854850	lisdexamfetamine dimesylate 50 MG Oral Capsule	SCD	0e024b69-567c-4b40-9c3e-a2daec34256c	5
854846	lisdexamfetamine dimesylate 60 MG Oral Capsule	SCD	0e024b69-567c-4b40-9c3e-a2daec34256c	5
854842	lisdexamfetamine dimesylate 70 MG Oral Capsule	SCD	0e024b69-567c-4b40-9c3e-a2daec34256c	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
64850-555-01	64850055501	100 CAPSULE in 1 BOTTLE (64850-555-01)	100 capsule	2024-11-15	No	No	Current