FDA.reportPublic FDA data

Lisdexamfetamine Dimesylate

Product NDC
0406-5128
11-digit product format
004065128
Labeler code
0406
Product ID
0406-5128_02215a03-fa4d-4785-9d38-4f22d92faf31
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisdexamfetamine Dimesylate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
SpecGx LLC
Application
ANDA218850
Marketing category
ANDA
Marketing start
2024-12-17
Substance
LISDEXAMFETAMINE DIMESYLATE
Active strength
50 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218850-001LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE10MGTABLET, CHEWABLE / ORALAB2024-12-17
A218850-002LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE20MGTABLET, CHEWABLE / ORALAB2024-12-17
A218850-003LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE30MGTABLET, CHEWABLE / ORALAB2024-12-17
A218850-004LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE40MGTABLET, CHEWABLE / ORALAB2024-12-17
A218850-005LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE50MGTABLET, CHEWABLE / ORALAB2024-12-17
A218850-006LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE60MGTABLET, CHEWABLE / ORALAB2024-12-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218850-001AB
A218850-002AB
A218850-003AB
A218850-004AB
A218850-005AB
A218850-006AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A218850-001LISDEXAMFETAMINE DIMESYLATE10MGTABLET, CHEWABLE / ORALAB2024-12-17a50c72e98297…
2026-08-01 22:54:322026-06A218850-002LISDEXAMFETAMINE DIMESYLATE20MGTABLET, CHEWABLE / ORALAB2024-12-17a50c72e98297…
2026-08-01 22:54:322026-06A218850-003LISDEXAMFETAMINE DIMESYLATE30MGTABLET, CHEWABLE / ORALAB2024-12-17a50c72e98297…
2026-08-01 22:54:322026-06A218850-004LISDEXAMFETAMINE DIMESYLATE40MGTABLET, CHEWABLE / ORALAB2024-12-17a50c72e98297…
2026-08-01 22:54:322026-06A218850-005LISDEXAMFETAMINE DIMESYLATE50MGTABLET, CHEWABLE / ORALAB2024-12-17a50c72e98297…
2026-08-01 22:54:322026-06A218850-006LISDEXAMFETAMINE DIMESYLATE60MGTABLET, CHEWABLE / ORALAB2024-12-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A218850-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A218850-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A218850-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A218850-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A218850-005AB1a50c72e98297…
2026-08-01 22:54:322026-06A218850-006AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lisdexamfetamine DimesylateLISDEXAMFETAMINE DIMESYLATESpecGx LLC3a79b2ab-4131-4978-99a0-0119df57d5fe2025-11-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218850
application number: ANDA218850
ndc (product): 0406-5128

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LISDEXAMFETAMINE DIMESYLATE50 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 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1871456Internal RxNorm lookup
1871460Internal RxNorm lookup
1871462Internal RxNorm lookup
1871464Internal RxNorm lookup
1871466Internal RxNorm lookup
1871468Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3a79b2ab-4131-4978-99a0-0119df57d5feAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb29ac3a-860f-7ed2-7559-c97af4af1704Product name320250603
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0406-5128-01Lisdexamfetamine Dimesylate100 in 1 BOTTLETABLET, CHEWABLE1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-5128-01EA - Each0406-5128a0b348ec-77cb-4dab-a111-b47deaecac7e12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0406-5128LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE [SPECGX LLC]4Current NDC, 1 package rows20241226_3a79b2ab-4131-4978-99a0-0119df57d5fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1871464lisdexamfetamine dimesylate 10 MG Chewable TabletPSN3a79b2ab-4131-4978-99a0-0119df57d5fe5
1871462lisdexamfetamine dimesylate 20 MG Chewable TabletPSN3a79b2ab-4131-4978-99a0-0119df57d5fe5
1871460lisdexamfetamine dimesylate 30 MG Chewable TabletPSN3a79b2ab-4131-4978-99a0-0119df57d5fe5
1871456lisdexamfetamine dimesylate 40 MG Chewable TabletPSN3a79b2ab-4131-4978-99a0-0119df57d5fe5
1871468lisdexamfetamine dimesylate 50 MG Chewable TabletPSN3a79b2ab-4131-4978-99a0-0119df57d5fe5
1871466lisdexamfetamine dimesylate 60 MG Chewable TabletPSN3a79b2ab-4131-4978-99a0-0119df57d5fe5
1871464lisdexamfetamine dimesylate 10 MG Chewable TabletSCD3a79b2ab-4131-4978-99a0-0119df57d5fe5
1871462lisdexamfetamine dimesylate 20 MG Chewable TabletSCD3a79b2ab-4131-4978-99a0-0119df57d5fe5
1871460lisdexamfetamine dimesylate 30 MG Chewable TabletSCD3a79b2ab-4131-4978-99a0-0119df57d5fe5
1871456lisdexamfetamine dimesylate 40 MG Chewable TabletSCD3a79b2ab-4131-4978-99a0-0119df57d5fe5
1871468lisdexamfetamine dimesylate 50 MG Chewable TabletSCD3a79b2ab-4131-4978-99a0-0119df57d5fe5
1871466lisdexamfetamine dimesylate 60 MG Chewable TabletSCD3a79b2ab-4131-4978-99a0-0119df57d5fe5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0406-5128-0100406512801100 TABLET, CHEWABLE in 1 BOTTLE (0406-5128-01) 2024-12-17NoNoCurrent