LISDEXAMFETAMINE DIMESYLATE

Product NDC: 72162-2452
Requested package NDC: 72162-2452-9
11-digit product format: 721622452
Labeler code: 72162
Product ID: 72162-2452_b41b15a1-e7fa-40bf-b395-aff2b3aee74a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LISDEXAMFETAMINE DIMESYLATE
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA215330
Marketing category: ANDA
Marketing start: 2024-01-30
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	Approval date
A215330-001	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	10MG	CAPSULE / ORAL	AB	2023-08-25
A215330-002	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	20MG	CAPSULE / ORAL	AB	2023-08-25
A215330-003	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	30MG	CAPSULE / ORAL	AB	2023-08-25
A215330-004	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	40MG	CAPSULE / ORAL	AB	2023-08-25
A215330-005	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	50MG	CAPSULE / ORAL	AB	2023-08-25
A215330-006	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	60MG	CAPSULE / ORAL	AB	2023-08-25
A215330-007	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	70MG	CAPSULE / ORAL	AB	2023-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215330-001	AB
A215330-002	AB
A215330-003	AB
A215330-004	AB
A215330-005	AB
A215330-006	AB
A215330-007	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 4 · 140 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	A215330-001	LISDEXAMFETAMINE DIMESYLATE	10MG	CAPSULE / ORAL	AB	2023-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215330-002	LISDEXAMFETAMINE DIMESYLATE	20MG	CAPSULE / ORAL	AB	2023-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215330-003	LISDEXAMFETAMINE DIMESYLATE	30MG	CAPSULE / ORAL	AB	2023-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215330-004	LISDEXAMFETAMINE DIMESYLATE	40MG	CAPSULE / ORAL	AB	2023-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215330-005	LISDEXAMFETAMINE DIMESYLATE	50MG	CAPSULE / ORAL	AB	2023-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215330-006	LISDEXAMFETAMINE DIMESYLATE	60MG	CAPSULE / ORAL	AB	2023-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215330-007	LISDEXAMFETAMINE DIMESYLATE	70MG	CAPSULE / ORAL	AB	2023-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215330-001	LISDEXAMFETAMINE DIMESYLATE	10MG	CAPSULE / ORAL	AB	2023-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215330-002	LISDEXAMFETAMINE DIMESYLATE	20MG	CAPSULE / ORAL	AB	2023-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215330-003	LISDEXAMFETAMINE DIMESYLATE	30MG	CAPSULE / ORAL	AB	2023-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215330-004	LISDEXAMFETAMINE DIMESYLATE	40MG	CAPSULE / ORAL	AB	2023-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215330-005	LISDEXAMFETAMINE DIMESYLATE	50MG	CAPSULE / ORAL	AB	2023-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215330-006	LISDEXAMFETAMINE DIMESYLATE	60MG	CAPSULE / ORAL	AB	2023-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215330-007	LISDEXAMFETAMINE DIMESYLATE	70MG	CAPSULE / ORAL	AB	2023-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215330-001	LISDEXAMFETAMINE DIMESYLATE	10MG	CAPSULE / ORAL	AB	2023-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215330-002	LISDEXAMFETAMINE DIMESYLATE	20MG	CAPSULE / ORAL	AB	2023-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215330-003	LISDEXAMFETAMINE DIMESYLATE	30MG	CAPSULE / ORAL	AB	2023-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215330-004	LISDEXAMFETAMINE DIMESYLATE	40MG	CAPSULE / ORAL	AB	2023-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215330-005	LISDEXAMFETAMINE DIMESYLATE	50MG	CAPSULE / ORAL	AB	2023-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215330-006	LISDEXAMFETAMINE DIMESYLATE	60MG	CAPSULE / ORAL	AB	2023-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215330-007	LISDEXAMFETAMINE DIMESYLATE	70MG	CAPSULE / ORAL	AB	2023-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215330-001	LISDEXAMFETAMINE DIMESYLATE	10MG	CAPSULE / ORAL	AB	2023-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215330-002	LISDEXAMFETAMINE DIMESYLATE	20MG	CAPSULE / ORAL	AB	2023-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215330-003	LISDEXAMFETAMINE DIMESYLATE	30MG	CAPSULE / ORAL	AB	2023-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215330-004	LISDEXAMFETAMINE DIMESYLATE	40MG	CAPSULE / ORAL	AB	2023-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215330-005	LISDEXAMFETAMINE DIMESYLATE	50MG	CAPSULE / ORAL	AB	2023-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215330-006	LISDEXAMFETAMINE DIMESYLATE	60MG	CAPSULE / ORAL	AB	2023-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215330-007	LISDEXAMFETAMINE DIMESYLATE	70MG	CAPSULE / ORAL	AB	2023-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215330-001	LISDEXAMFETAMINE DIMESYLATE	10MG	CAPSULE / ORAL	AB	2023-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215330-002	LISDEXAMFETAMINE DIMESYLATE	20MG	CAPSULE / ORAL	AB	2023-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215330-003	LISDEXAMFETAMINE DIMESYLATE	30MG	CAPSULE / ORAL	AB	2023-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215330-004	LISDEXAMFETAMINE DIMESYLATE	40MG	CAPSULE / ORAL	AB	2023-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215330-005	LISDEXAMFETAMINE DIMESYLATE	50MG	CAPSULE / ORAL	AB	2023-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215330-006	LISDEXAMFETAMINE DIMESYLATE	60MG	CAPSULE / ORAL	AB	2023-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215330-007	LISDEXAMFETAMINE DIMESYLATE	70MG	CAPSULE / ORAL	AB	2023-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215330-001	LISDEXAMFETAMINE DIMESYLATE	10MG	CAPSULE / ORAL	AB	2023-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215330-002	LISDEXAMFETAMINE DIMESYLATE	20MG	CAPSULE / ORAL	AB	2023-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215330-003	LISDEXAMFETAMINE DIMESYLATE	30MG	CAPSULE / ORAL	AB	2023-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215330-004	LISDEXAMFETAMINE DIMESYLATE	40MG	CAPSULE / ORAL	AB	2023-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215330-005	LISDEXAMFETAMINE DIMESYLATE	50MG	CAPSULE / ORAL	AB	2023-08-25	`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	A215330-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215330-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215330-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215330-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215330-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215330-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215330-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215330-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215330-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215330-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215330-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215330-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215330-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215330-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215330-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215330-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215330-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215330-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215330-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215330-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215330-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215330-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215330-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215330-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215330-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215330-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215330-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215330-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215330-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215330-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215330-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215330-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215330-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215330-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215330-007	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215330-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215330-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215330-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215330-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215330-005	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	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 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
854830	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
5eab8a4f-0438-4f5c-8f32-53cc98ea134b	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	SPL version
72162-2452-1	LISDEXAMFETAMINE DIMESYLATE	100 in 1 BOTTLE	CAPSULE	100	102
72162-2452-3	LISDEXAMFETAMINE DIMESYLATE	30 in 1 BOTTLE	CAPSULE	30	102
72162-2452-9	LISDEXAMFETAMINE DIMESYLATE	90 in 1 BOTTLE	CAPSULE	90	102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72162-2452-1	EA - Each	72162-2452	04115045-67de-4d1a-905d-e52ec83a617e	1	2025-03-04
72162-2452-3	EA - Each	72162-2452	46f16c33-4af4-4b89-89a7-ed6660920341	1	2025-03-04
72162-2452-9	EA - Each	72162-2452	1f01a38d-00df-4d3a-af3e-1472f84867ee	1	2025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72162-2452	LISDEXAMFETAMINE DIMESYLATE CAPSULE [BRYANT RANCH PREPACK]	100	Current NDC, 3 package rows	20250129_5eab8a4f-0438-4f5c-8f32-53cc98ea134b.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	Bryant Ranch Prepack	281842ea-d165-4b6d-a366-791239be8c2e	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215330 application number: ANDA215330
LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	Rhodes Pharmaceuticals LLC	d918b40d-a461-41bc-b6c0-83dc76c28e32	2026-05-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215330 application number: ANDA215330
LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	Bryant Ranch Prepack	483cc379-fd34-45aa-a5c0-09c4d0c167d9	2026-03-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215330 application number: ANDA215330
LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	Bryant Ranch Prepack	768d3b93-c1c6-4bf2-a4d8-cee017ab4a16	2026-03-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215330 application number: ANDA215330
LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	Bryant Ranch Prepack	b548020c-dd53-4929-96d6-175a78eba5bb	2026-03-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215330 application number: ANDA215330
LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	Bryant Ranch Prepack	3b69003f-f7b4-4e52-acde-4b229d6c51fe	2026-03-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215330 application number: ANDA215330
LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	Bryant Ranch Prepack	5eab8a4f-0438-4f5c-8f32-53cc98ea134b	2026-03-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215330 application number: ANDA215330 ndc (package): 72162-2452-9 ndc (product): 72162-2452 ndc11 (package): 72162245209
LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE	Bryant Ranch Prepack	18a97c88-0f72-4b02-be0d-4d093886cca5	2026-03-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215330 application number: ANDA215330

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
854830	lisdexamfetamine dimesylate 20 MG Oral Capsule	PSN	5eab8a4f-0438-4f5c-8f32-53cc98ea134b	102
854830	lisdexamfetamine dimesylate 20 MG Oral Capsule	SCD	5eab8a4f-0438-4f5c-8f32-53cc98ea134b	102

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72162-2452-9	72162245209	90 CAPSULE in 1 BOTTLE (72162-2452-9)	90 capsule	2026-03-16	No	No	Current