FDA.reportPublic FDA data

Lisdexamfetamine Dimesylate

Product NDC
0054-0373
11-digit product format
000540373
Labeler code
0054
Product ID
0054-0373_54a99322-a206-447c-b820-9e1b7e525816
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lisdexamfetamine dimesylate
Dosage form
CAPSULE
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA202827
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
A202827-001LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE20MGCAPSULE / ORALAB2023-08-25
A202827-002LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE30MGCAPSULE / ORALAB2023-08-25
A202827-003LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE40MGCAPSULE / ORALAB2023-08-25
A202827-004LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE50MGCAPSULE / ORALAB2023-08-25
A202827-005LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE60MGCAPSULE / ORALAB2023-08-25
A202827-006LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE70MGCAPSULE / ORALAB2023-08-25
A202827-007LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE10MGCAPSULE / ORALAB2024-01-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202827-001AB
A202827-002AB
A202827-003AB
A202827-004AB
A202827-005AB
A202827-006AB
A202827-007AB

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 22:54:322026-06A202827-001LISDEXAMFETAMINE DIMESYLATE20MGCAPSULE / ORALAB2023-08-25a50c72e98297…
2026-08-01 22:54:322026-06A202827-002LISDEXAMFETAMINE DIMESYLATE30MGCAPSULE / ORALAB2023-08-25a50c72e98297…
2026-08-01 22:54:322026-06A202827-003LISDEXAMFETAMINE DIMESYLATE40MGCAPSULE / ORALAB2023-08-25a50c72e98297…
2026-08-01 22:54:322026-06A202827-004LISDEXAMFETAMINE DIMESYLATE50MGCAPSULE / ORALAB2023-08-25a50c72e98297…
2026-08-01 22:54:322026-06A202827-005LISDEXAMFETAMINE DIMESYLATE60MGCAPSULE / ORALAB2023-08-25a50c72e98297…
2026-08-01 22:54:322026-06A202827-006LISDEXAMFETAMINE DIMESYLATE70MGCAPSULE / ORALAB2023-08-25a50c72e98297…
2026-08-01 22:54:322026-06A202827-007LISDEXAMFETAMINE DIMESYLATE10MGCAPSULE / ORALAB2024-01-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202827-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A202827-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A202827-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A202827-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A202827-005AB1a50c72e98297…
2026-08-01 22:54:322026-06A202827-006AB1a50c72e98297…
2026-08-01 22:54:322026-06A202827-007AB1a50c72e98297…

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 DimesylateLISDEXAMFETAMINE DIMESYLATEHikma Pharmaceuticals USA Inc.6740a621-9bec-4178-a4fc-a3fc89f34e0a2026-04-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202827
application number: ANDA202827
ndc (product): 0054-0373

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
6740a621-9bec-4178-a4fc-a3fc89f34e0aAvailable 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
0054-0373-25Lisdexamfetamine Dimesylate100 in 1 BOTTLECAPSULE1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0373-25EA - Each0054-0373637d86e7-15f1-4172-a44d-f7b78da1058d12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-0373LISDEXAMFETAMINE DIMESYLATE CAPSULE [HIKMA PHARMACEUTICALS USA INC.]5Current NDC, 1 package rows20250402_6740a621-9bec-4178-a4fc-a3fc89f34e0a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1593856lisdexamfetamine dimesylate 10 MG Oral CapsulePSN6740a621-9bec-4178-a4fc-a3fc89f34e0a7
854830lisdexamfetamine dimesylate 20 MG Oral CapsulePSN6740a621-9bec-4178-a4fc-a3fc89f34e0a7
854834lisdexamfetamine dimesylate 30 MG Oral CapsulePSN6740a621-9bec-4178-a4fc-a3fc89f34e0a7
854838lisdexamfetamine dimesylate 40 MG Oral CapsulePSN6740a621-9bec-4178-a4fc-a3fc89f34e0a7
854850lisdexamfetamine dimesylate 50 MG Oral CapsulePSN6740a621-9bec-4178-a4fc-a3fc89f34e0a7
854846lisdexamfetamine dimesylate 60 MG Oral CapsulePSN6740a621-9bec-4178-a4fc-a3fc89f34e0a7
854842lisdexamfetamine dimesylate 70 MG Oral CapsulePSN6740a621-9bec-4178-a4fc-a3fc89f34e0a7
1593856lisdexamfetamine dimesylate 10 MG Oral CapsuleSCD6740a621-9bec-4178-a4fc-a3fc89f34e0a7
854830lisdexamfetamine dimesylate 20 MG Oral CapsuleSCD6740a621-9bec-4178-a4fc-a3fc89f34e0a7
854834lisdexamfetamine dimesylate 30 MG Oral CapsuleSCD6740a621-9bec-4178-a4fc-a3fc89f34e0a7
854838lisdexamfetamine dimesylate 40 MG Oral CapsuleSCD6740a621-9bec-4178-a4fc-a3fc89f34e0a7
854850lisdexamfetamine dimesylate 50 MG Oral CapsuleSCD6740a621-9bec-4178-a4fc-a3fc89f34e0a7
854846lisdexamfetamine dimesylate 60 MG Oral CapsuleSCD6740a621-9bec-4178-a4fc-a3fc89f34e0a7
854842lisdexamfetamine dimesylate 70 MG Oral CapsuleSCD6740a621-9bec-4178-a4fc-a3fc89f34e0a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0054-0373-2500054037325100 CAPSULE in 1 BOTTLE (0054-0373-25) 100 capsule2023-08-25NoNoCurrent