FDA.reportPublic FDA data

LISDEXAMFETAMINE DIMESYLATE

Product NDC
42858-162
11-digit product format
428580162
Labeler code
42858
Product ID
42858-162_0002e227-1109-4ecc-a8c5-4b4f11fac3cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LISDEXAMFETAMINE DIMESYLATE
Dosage form
CAPSULE
Route
ORAL
Labeler
Rhodes Pharmaceuticals LLC
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 42.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215330-001LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE10MGCAPSULE / ORALAB2023-08-25
A215330-002LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE20MGCAPSULE / ORALAB2023-08-25
A215330-003LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE30MGCAPSULE / ORALAB2023-08-25
A215330-004LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE40MGCAPSULE / ORALAB2023-08-25
A215330-005LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE50MGCAPSULE / ORALAB2023-08-25
A215330-006LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE60MGCAPSULE / ORALAB2023-08-25
A215330-007LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE70MGCAPSULE / ORALAB2023-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215330-001AB
A215330-002AB
A215330-003AB
A215330-004AB
A215330-005AB
A215330-006AB
A215330-007AB

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 · 147 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A215330-001LISDEXAMFETAMINE DIMESYLATE10MGCAPSULE / ORALAB2023-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A215330-002LISDEXAMFETAMINE DIMESYLATE20MGCAPSULE / ORALAB2023-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A215330-003LISDEXAMFETAMINE DIMESYLATE30MGCAPSULE / ORALAB2023-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A215330-004LISDEXAMFETAMINE DIMESYLATE40MGCAPSULE / ORALAB2023-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A215330-005LISDEXAMFETAMINE DIMESYLATE50MGCAPSULE / ORALAB2023-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A215330-006LISDEXAMFETAMINE DIMESYLATE60MGCAPSULE / ORALAB2023-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A215330-007LISDEXAMFETAMINE DIMESYLATE70MGCAPSULE / ORALAB2023-08-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215330-001LISDEXAMFETAMINE DIMESYLATE10MGCAPSULE / ORALAB2023-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215330-002LISDEXAMFETAMINE DIMESYLATE20MGCAPSULE / ORALAB2023-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215330-003LISDEXAMFETAMINE DIMESYLATE30MGCAPSULE / ORALAB2023-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215330-004LISDEXAMFETAMINE DIMESYLATE40MGCAPSULE / ORALAB2023-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215330-005LISDEXAMFETAMINE DIMESYLATE50MGCAPSULE / ORALAB2023-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215330-006LISDEXAMFETAMINE DIMESYLATE60MGCAPSULE / ORALAB2023-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215330-007LISDEXAMFETAMINE DIMESYLATE70MGCAPSULE / ORALAB2023-08-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215330-001LISDEXAMFETAMINE DIMESYLATE10MGCAPSULE / ORALAB2023-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215330-002LISDEXAMFETAMINE DIMESYLATE20MGCAPSULE / ORALAB2023-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215330-003LISDEXAMFETAMINE DIMESYLATE30MGCAPSULE / ORALAB2023-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215330-004LISDEXAMFETAMINE DIMESYLATE40MGCAPSULE / ORALAB2023-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215330-005LISDEXAMFETAMINE DIMESYLATE50MGCAPSULE / ORALAB2023-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215330-006LISDEXAMFETAMINE DIMESYLATE60MGCAPSULE / ORALAB2023-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215330-007LISDEXAMFETAMINE DIMESYLATE70MGCAPSULE / ORALAB2023-08-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A215330-001LISDEXAMFETAMINE DIMESYLATE10MGCAPSULE / ORALAB2023-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215330-002LISDEXAMFETAMINE DIMESYLATE20MGCAPSULE / ORALAB2023-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215330-003LISDEXAMFETAMINE DIMESYLATE30MGCAPSULE / ORALAB2023-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215330-004LISDEXAMFETAMINE DIMESYLATE40MGCAPSULE / ORALAB2023-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215330-005LISDEXAMFETAMINE DIMESYLATE50MGCAPSULE / ORALAB2023-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215330-006LISDEXAMFETAMINE DIMESYLATE60MGCAPSULE / ORALAB2023-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215330-007LISDEXAMFETAMINE DIMESYLATE70MGCAPSULE / ORALAB2023-08-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215330-001LISDEXAMFETAMINE DIMESYLATE10MGCAPSULE / ORALAB2023-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215330-002LISDEXAMFETAMINE DIMESYLATE20MGCAPSULE / ORALAB2023-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215330-003LISDEXAMFETAMINE DIMESYLATE30MGCAPSULE / ORALAB2023-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215330-004LISDEXAMFETAMINE DIMESYLATE40MGCAPSULE / ORALAB2023-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215330-005LISDEXAMFETAMINE DIMESYLATE50MGCAPSULE / ORALAB2023-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215330-006LISDEXAMFETAMINE DIMESYLATE60MGCAPSULE / ORALAB2023-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215330-007LISDEXAMFETAMINE DIMESYLATE70MGCAPSULE / ORALAB2023-08-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215330-001LISDEXAMFETAMINE DIMESYLATE10MGCAPSULE / ORALAB2023-08-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215330-002LISDEXAMFETAMINE DIMESYLATE20MGCAPSULE / ORALAB2023-08-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215330-003LISDEXAMFETAMINE DIMESYLATE30MGCAPSULE / ORALAB2023-08-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215330-004LISDEXAMFETAMINE DIMESYLATE40MGCAPSULE / ORALAB2023-08-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215330-005LISDEXAMFETAMINE DIMESYLATE50MGCAPSULE / ORALAB2023-08-25b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 147 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A215330-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215330-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215330-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215330-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215330-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215330-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215330-007AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215330-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215330-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215330-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215330-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215330-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215330-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215330-007AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215330-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215330-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215330-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215330-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215330-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215330-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215330-007AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215330-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215330-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215330-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215330-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215330-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215330-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215330-007AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215330-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215330-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215330-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215330-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215330-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215330-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215330-007AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215330-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215330-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215330-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215330-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215330-005AB1b8a1b40f171c…

Additional Listing Data#

Finished product
Yes
Brand name base
LISDEXAMFETAMINE DIMESYLATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LISDEXAMFETAMINE DIMESYLATE20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SJT761GEGSInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
854830Internal RxNorm lookup
854834Internal RxNorm lookup
854838Internal RxNorm lookup
854842Internal RxNorm lookup
854846Internal RxNorm lookup
854850Internal RxNorm lookup
1593856Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d918b40d-a461-41bc-b6c0-83dc76c28e32Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb29ac3a-860f-7ed2-7559-c97af4af1704Product name320250603

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42858-162-01LISDEXAMFETAMINE DIMESYLATE100 in 1 BOTTLE, PLASTICCAPSULE1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42858-162-01EA - Each42858-16266c33bbb-2656-4bed-8dd3-63857672081312024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42858-162LISDEXAMFETAMINE DIMESYLATE CAPSULE [RHODES PHARMACEUTICALS]5Current NDC, 1 package rows20241115_d918b40d-a461-41bc-b6c0-83dc76c28e32.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATEBryant Ranch Prepack281842ea-d165-4b6d-a366-791239be8c2e2026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215330
application number: ANDA215330
LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATERhodes Pharmaceuticals LLCd918b40d-a461-41bc-b6c0-83dc76c28e322026-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215330
application number: ANDA215330
ndc (product): 42858-162
LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATEBryant Ranch Prepack483cc379-fd34-45aa-a5c0-09c4d0c167d92026-03-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215330
application number: ANDA215330
LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATEBryant Ranch Prepack768d3b93-c1c6-4bf2-a4d8-cee017ab4a162026-03-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215330
application number: ANDA215330
LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATEBryant Ranch Prepackb548020c-dd53-4929-96d6-175a78eba5bb2026-03-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215330
application number: ANDA215330
LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATEBryant Ranch Prepack3b69003f-f7b4-4e52-acde-4b229d6c51fe2026-03-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215330
application number: ANDA215330
LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATEBryant Ranch Prepack5eab8a4f-0438-4f5c-8f32-53cc98ea134b2026-03-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215330
application number: ANDA215330
LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATEBryant Ranch Prepack18a97c88-0f72-4b02-be0d-4d093886cca52026-03-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215330
application number: ANDA215330

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854830lisdexamfetamine dimesylate 20 MG Oral CapsulePSN5eab8a4f-0438-4f5c-8f32-53cc98ea134b102
854830lisdexamfetamine dimesylate 20 MG Oral CapsuleSCD5eab8a4f-0438-4f5c-8f32-53cc98ea134b102
1593856lisdexamfetamine dimesylate 10 MG Oral CapsulePSNd918b40d-a461-41bc-b6c0-83dc76c28e327
854830lisdexamfetamine dimesylate 20 MG Oral CapsulePSNd918b40d-a461-41bc-b6c0-83dc76c28e327
854834lisdexamfetamine dimesylate 30 MG Oral CapsulePSNd918b40d-a461-41bc-b6c0-83dc76c28e327
854838lisdexamfetamine dimesylate 40 MG Oral CapsulePSNd918b40d-a461-41bc-b6c0-83dc76c28e327
854850lisdexamfetamine dimesylate 50 MG Oral CapsulePSNd918b40d-a461-41bc-b6c0-83dc76c28e327
854846lisdexamfetamine dimesylate 60 MG Oral CapsulePSNd918b40d-a461-41bc-b6c0-83dc76c28e327
854842lisdexamfetamine dimesylate 70 MG Oral CapsulePSNd918b40d-a461-41bc-b6c0-83dc76c28e327
1593856lisdexamfetamine dimesylate 10 MG Oral CapsuleSCDd918b40d-a461-41bc-b6c0-83dc76c28e327
854830lisdexamfetamine dimesylate 20 MG Oral CapsuleSCDd918b40d-a461-41bc-b6c0-83dc76c28e327
854834lisdexamfetamine dimesylate 30 MG Oral CapsuleSCDd918b40d-a461-41bc-b6c0-83dc76c28e327
854838lisdexamfetamine dimesylate 40 MG Oral CapsuleSCDd918b40d-a461-41bc-b6c0-83dc76c28e327
854850lisdexamfetamine dimesylate 50 MG Oral CapsuleSCDd918b40d-a461-41bc-b6c0-83dc76c28e327
854846lisdexamfetamine dimesylate 60 MG Oral CapsuleSCDd918b40d-a461-41bc-b6c0-83dc76c28e327
854842lisdexamfetamine dimesylate 70 MG Oral CapsuleSCDd918b40d-a461-41bc-b6c0-83dc76c28e327

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42858-162-0142858016201100 CAPSULE in 1 BOTTLE, PLASTIC (42858-162-01) 100 capsule2024-01-30NoNoCurrent