Lisdexamfetamine Dimesylate

Product NDC
0406-5129
11-digit product format
004065129
Labeler code
0406
Product ID
0406-5129_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
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 42.

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.

Product history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A218850-001LISDEXAMFETAMINE DIMESYLATE10MGTABLET, CHEWABLE / ORALAB2024-12-17caaa826d4ba7…
2026-08-18 06:07:402026-07A218850-002LISDEXAMFETAMINE DIMESYLATE20MGTABLET, CHEWABLE / ORALAB2024-12-17caaa826d4ba7…
2026-08-18 06:07:402026-07A218850-003LISDEXAMFETAMINE DIMESYLATE30MGTABLET, CHEWABLE / ORALAB2024-12-17caaa826d4ba7…
2026-08-18 06:07:402026-07A218850-004LISDEXAMFETAMINE DIMESYLATE40MGTABLET, CHEWABLE / ORALAB2024-12-17caaa826d4ba7…
2026-08-18 06:07:402026-07A218850-005LISDEXAMFETAMINE DIMESYLATE50MGTABLET, CHEWABLE / ORALAB2024-12-17caaa826d4ba7…
2026-08-18 06:07:402026-07A218850-006LISDEXAMFETAMINE DIMESYLATE60MGTABLET, CHEWABLE / ORALAB2024-12-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218850-001LISDEXAMFETAMINE DIMESYLATE10MGTABLET, CHEWABLE / ORALAB2024-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218850-002LISDEXAMFETAMINE DIMESYLATE20MGTABLET, CHEWABLE / ORALAB2024-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218850-003LISDEXAMFETAMINE DIMESYLATE30MGTABLET, CHEWABLE / ORALAB2024-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218850-004LISDEXAMFETAMINE DIMESYLATE40MGTABLET, CHEWABLE / ORALAB2024-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218850-005LISDEXAMFETAMINE DIMESYLATE50MGTABLET, CHEWABLE / ORALAB2024-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218850-006LISDEXAMFETAMINE DIMESYLATE60MGTABLET, CHEWABLE / ORALAB2024-12-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218850-001LISDEXAMFETAMINE DIMESYLATE10MGTABLET, CHEWABLE / ORALAB2024-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218850-002LISDEXAMFETAMINE DIMESYLATE20MGTABLET, CHEWABLE / ORALAB2024-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218850-003LISDEXAMFETAMINE DIMESYLATE30MGTABLET, CHEWABLE / ORALAB2024-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218850-004LISDEXAMFETAMINE DIMESYLATE40MGTABLET, CHEWABLE / ORALAB2024-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218850-005LISDEXAMFETAMINE DIMESYLATE50MGTABLET, CHEWABLE / ORALAB2024-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218850-006LISDEXAMFETAMINE DIMESYLATE60MGTABLET, CHEWABLE / ORALAB2024-12-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A218850-001LISDEXAMFETAMINE DIMESYLATE10MGTABLET, CHEWABLE / ORALAB2024-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218850-002LISDEXAMFETAMINE DIMESYLATE20MGTABLET, CHEWABLE / ORALAB2024-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218850-003LISDEXAMFETAMINE DIMESYLATE30MGTABLET, CHEWABLE / ORALAB2024-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218850-004LISDEXAMFETAMINE DIMESYLATE40MGTABLET, CHEWABLE / ORALAB2024-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218850-005LISDEXAMFETAMINE DIMESYLATE50MGTABLET, CHEWABLE / ORALAB2024-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218850-006LISDEXAMFETAMINE DIMESYLATE60MGTABLET, CHEWABLE / ORALAB2024-12-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218850-001LISDEXAMFETAMINE DIMESYLATE10MGTABLET, CHEWABLE / ORALAB2024-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218850-002LISDEXAMFETAMINE DIMESYLATE20MGTABLET, CHEWABLE / ORALAB2024-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218850-003LISDEXAMFETAMINE DIMESYLATE30MGTABLET, CHEWABLE / ORALAB2024-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218850-004LISDEXAMFETAMINE DIMESYLATE40MGTABLET, CHEWABLE / ORALAB2024-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218850-005LISDEXAMFETAMINE DIMESYLATE50MGTABLET, CHEWABLE / ORALAB2024-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218850-006LISDEXAMFETAMINE DIMESYLATE60MGTABLET, CHEWABLE / ORALAB2024-12-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218850-001LISDEXAMFETAMINE DIMESYLATE10MGTABLET, CHEWABLE / ORALAB2024-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218850-002LISDEXAMFETAMINE DIMESYLATE20MGTABLET, CHEWABLE / ORALAB2024-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218850-003LISDEXAMFETAMINE DIMESYLATE30MGTABLET, CHEWABLE / ORALAB2024-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218850-004LISDEXAMFETAMINE DIMESYLATE40MGTABLET, CHEWABLE / ORALAB2024-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218850-005LISDEXAMFETAMINE DIMESYLATE50MGTABLET, CHEWABLE / ORALAB2024-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218850-006LISDEXAMFETAMINE DIMESYLATE60MGTABLET, CHEWABLE / ORALAB2024-12-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218850-001LISDEXAMFETAMINE DIMESYLATE10MGTABLET, CHEWABLE / ORALAB2024-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218850-002LISDEXAMFETAMINE DIMESYLATE20MGTABLET, CHEWABLE / ORALAB2024-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218850-003LISDEXAMFETAMINE DIMESYLATE30MGTABLET, CHEWABLE / ORALAB2024-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218850-004LISDEXAMFETAMINE DIMESYLATE40MGTABLET, CHEWABLE / ORALAB2024-12-1703ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A218850-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218850-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218850-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218850-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218850-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218850-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218850-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218850-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218850-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218850-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218850-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218850-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218850-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218850-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218850-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218850-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218850-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218850-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218850-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218850-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218850-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218850-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218850-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218850-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218850-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218850-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218850-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218850-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218850-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218850-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218850-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218850-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218850-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218850-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218850-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218850-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218850-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218850-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218850-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218850-004AB103ed91905a0d…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LISDEXAMFETAMINE DIMESYLATE60 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
0406-5129-01Lisdexamfetamine Dimesylate100 in 1 BOTTLETABLET, CHEWABLE1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-5129-01EA - Each0406-5129f8da7b45-6a72-47f4-87af-6382e789fbd212025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0406-5129LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE [SPECGX LLC]4Current NDC, 1 package rows20241226_3a79b2ab-4131-4978-99a0-0119df57d5fe.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
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): 0406-5129

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
0406-5129-0100406512901100 TABLET, CHEWABLE in 1 BOTTLE (0406-5129-01) 2024-12-17NoNoCurrent