FDA.reportPublic FDA data

Lisdexamfetamine Dimesylate

Product NDC
0378-6858
11-digit product format
003786858
Labeler code
0378
Product ID
0378-6858_63cd6f7c-f976-440e-a35f-e71a9f2fd1bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lisdexamfetamine
Dosage form
CAPSULE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA202835
Marketing category
ANDA
Marketing start
2023-08-25
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 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202835-001LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE10MGCAPSULE / ORALAB2023-08-25
A202835-002LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE20MGCAPSULE / ORALAB2023-08-25
A202835-003LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE30MGCAPSULE / ORALAB2023-08-25
A202835-004LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE40MGCAPSULE / ORALAB2023-08-25
A202835-005LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE50MGCAPSULE / ORALAB2023-08-25
A202835-006LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE60MGCAPSULE / ORALAB2023-08-25
A202835-007LISDEXAMFETAMINE 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
A202835-001AB
A202835-002AB
A202835-003AB
A202835-004AB
A202835-005AB
A202835-006AB
A202835-007AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A202835-001LISDEXAMFETAMINE DIMESYLATE10MGCAPSULE / ORALAB2023-08-25a50c72e98297…
2026-08-01 22:54:322026-06A202835-002LISDEXAMFETAMINE DIMESYLATE20MGCAPSULE / ORALAB2023-08-25a50c72e98297…
2026-08-01 22:54:322026-06A202835-003LISDEXAMFETAMINE DIMESYLATE30MGCAPSULE / ORALAB2023-08-25a50c72e98297…
2026-08-01 22:54:322026-06A202835-004LISDEXAMFETAMINE DIMESYLATE40MGCAPSULE / ORALAB2023-08-25a50c72e98297…
2026-08-01 22:54:322026-06A202835-005LISDEXAMFETAMINE DIMESYLATE50MGCAPSULE / ORALAB2023-08-25a50c72e98297…
2026-08-01 22:54:322026-06A202835-006LISDEXAMFETAMINE DIMESYLATE60MGCAPSULE / ORALAB2023-08-25a50c72e98297…
2026-08-01 22:54:322026-06A202835-007LISDEXAMFETAMINE DIMESYLATE70MGCAPSULE / ORALAB2023-08-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202835-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A202835-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A202835-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A202835-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A202835-005AB1a50c72e98297…
2026-08-01 22:54:322026-06A202835-006AB1a50c72e98297…
2026-08-01 22:54:322026-06A202835-007AB1a50c72e98297…

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 DimesylateLISDEXAMFETAMINEMylan Pharmaceuticals Inc.efbde0f6-b848-4664-b741-c6c630e661082026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202835
application number: ANDA202835
ndc (product): 0378-6858

Additional Listing Data#

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

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 · 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
efbde0f6-b848-4664-b741-c6c630e66108Available 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
0378-6858-77Lisdexamfetamine Dimesylate90 in 1 BOTTLE, PLASTICCAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-6858-77EA - Each0378-6858d8ee8f8c-34e7-458b-8a76-c2180e90cba412023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-6858LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE) CAPSULE [MYLAN PHARMACEUTICALS INC.]2Current NDC, 1 package rows20240410_efbde0f6-b848-4664-b741-c6c630e66108.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1593856lisdexamfetamine dimesylate 10 MG Oral CapsulePSNefbde0f6-b848-4664-b741-c6c630e661083
854830lisdexamfetamine dimesylate 20 MG Oral CapsulePSNefbde0f6-b848-4664-b741-c6c630e661083
854834lisdexamfetamine dimesylate 30 MG Oral CapsulePSNefbde0f6-b848-4664-b741-c6c630e661083
854838lisdexamfetamine dimesylate 40 MG Oral CapsulePSNefbde0f6-b848-4664-b741-c6c630e661083
854850lisdexamfetamine dimesylate 50 MG Oral CapsulePSNefbde0f6-b848-4664-b741-c6c630e661083
854846lisdexamfetamine dimesylate 60 MG Oral CapsulePSNefbde0f6-b848-4664-b741-c6c630e661083
854842lisdexamfetamine dimesylate 70 MG Oral CapsulePSNefbde0f6-b848-4664-b741-c6c630e661083
1593856lisdexamfetamine dimesylate 10 MG Oral CapsuleSCDefbde0f6-b848-4664-b741-c6c630e661083
854830lisdexamfetamine dimesylate 20 MG Oral CapsuleSCDefbde0f6-b848-4664-b741-c6c630e661083
854834lisdexamfetamine dimesylate 30 MG Oral CapsuleSCDefbde0f6-b848-4664-b741-c6c630e661083
854838lisdexamfetamine dimesylate 40 MG Oral CapsuleSCDefbde0f6-b848-4664-b741-c6c630e661083
854850lisdexamfetamine dimesylate 50 MG Oral CapsuleSCDefbde0f6-b848-4664-b741-c6c630e661083
854846lisdexamfetamine dimesylate 60 MG Oral CapsuleSCDefbde0f6-b848-4664-b741-c6c630e661083
854842lisdexamfetamine dimesylate 70 MG Oral CapsuleSCDefbde0f6-b848-4664-b741-c6c630e661083

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0378-6858-770037868587790 CAPSULE in 1 BOTTLE, PLASTIC (0378-6858-77) 90 capsule2023-08-25NoNoCurrent