FDA.reportPublic FDA data

Lisdexamfetamine Dimesylate

Product NDC
65162-027
11-digit product format
651620027
Labeler code
65162
Product ID
65162-027_ba9f3370-3096-4d8c-9571-e28faf54291f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisdexamfetamine
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA202830
Marketing category
ANDA
Marketing start
2023-08-28
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
2027-12-31
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
A202830-001LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE20MGCAPSULE / ORALAB2023-08-25
A202830-002LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE30MGCAPSULE / ORALAB2023-08-25
A202830-003LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE40MGCAPSULE / ORALAB2023-08-25
A202830-004LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE50MGCAPSULE / ORALAB2023-08-25
A202830-005LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE60MGCAPSULE / ORALAB2023-08-25
A202830-006LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE70MGCAPSULE / ORALAB2023-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202830-001AB
A202830-002AB
A202830-003AB
A202830-004AB
A202830-005AB
A202830-006AB

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 22:54:322026-06A202830-001LISDEXAMFETAMINE DIMESYLATE20MGCAPSULE / ORALAB2023-08-25a50c72e98297…
2026-08-01 22:54:322026-06A202830-002LISDEXAMFETAMINE DIMESYLATE30MGCAPSULE / ORALAB2023-08-25a50c72e98297…
2026-08-01 22:54:322026-06A202830-003LISDEXAMFETAMINE DIMESYLATE40MGCAPSULE / ORALAB2023-08-25a50c72e98297…
2026-08-01 22:54:322026-06A202830-004LISDEXAMFETAMINE DIMESYLATE50MGCAPSULE / ORALAB2023-08-25a50c72e98297…
2026-08-01 22:54:322026-06A202830-005LISDEXAMFETAMINE DIMESYLATE60MGCAPSULE / ORALAB2023-08-25a50c72e98297…
2026-08-01 22:54:322026-06A202830-006LISDEXAMFETAMINE DIMESYLATE70MGCAPSULE / ORALAB2023-08-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202830-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A202830-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A202830-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A202830-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A202830-005AB1a50c72e98297…
2026-08-01 22:54:322026-06A202830-006AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lisdexamfetamine DimesylateLISDEXAMFETAMINEAmneal Pharmaceuticals LLCc11cb3b6-3dff-477b-a249-b4c3118edc5f2026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202830
application number: ANDA202830
ndc (product): 65162-027
Lisdexamfetamine DimesylateLISDEXAMFETAMINEAvKARE36c40404-fe94-6fb7-e063-6394a90a26572025-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202830
application number: ANDA202830

Additional Listing Data#

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

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
854830Internal RxNorm lookup
854834Internal RxNorm lookup
854838Internal RxNorm lookup
854842Internal RxNorm lookup
854846Internal RxNorm lookup
854850Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c11cb3b6-3dff-477b-a249-b4c3118edc5fAvailable 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
65162-027-09Lisdexamfetamine Dimesylate90 in 1 BOTTLECAPSULE9022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-027-09EA - Each65162-027184e0487-cf14-4bba-b8da-bda6caefeeae12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-027LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE) CAPSULE [AMNEAL PHARMACEUTICALS LLC]19Current NDC, 1 package rows20250216_c11cb3b6-3dff-477b-a249-b4c3118edc5f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854830lisdexamfetamine dimesylate 20 MG Oral CapsulePSNc11cb3b6-3dff-477b-a249-b4c3118edc5f22
854834lisdexamfetamine dimesylate 30 MG Oral CapsulePSNc11cb3b6-3dff-477b-a249-b4c3118edc5f22
854838lisdexamfetamine dimesylate 40 MG Oral CapsulePSNc11cb3b6-3dff-477b-a249-b4c3118edc5f22
854850lisdexamfetamine dimesylate 50 MG Oral CapsulePSNc11cb3b6-3dff-477b-a249-b4c3118edc5f22
854846lisdexamfetamine dimesylate 60 MG Oral CapsulePSNc11cb3b6-3dff-477b-a249-b4c3118edc5f22
854842lisdexamfetamine dimesylate 70 MG Oral CapsulePSNc11cb3b6-3dff-477b-a249-b4c3118edc5f22
854830lisdexamfetamine dimesylate 20 MG Oral CapsuleSCDc11cb3b6-3dff-477b-a249-b4c3118edc5f22
854834lisdexamfetamine dimesylate 30 MG Oral CapsuleSCDc11cb3b6-3dff-477b-a249-b4c3118edc5f22
854838lisdexamfetamine dimesylate 40 MG Oral CapsuleSCDc11cb3b6-3dff-477b-a249-b4c3118edc5f22
854850lisdexamfetamine dimesylate 50 MG Oral CapsuleSCDc11cb3b6-3dff-477b-a249-b4c3118edc5f22
854846lisdexamfetamine dimesylate 60 MG Oral CapsuleSCDc11cb3b6-3dff-477b-a249-b4c3118edc5f22
854842lisdexamfetamine dimesylate 70 MG Oral CapsuleSCDc11cb3b6-3dff-477b-a249-b4c3118edc5f22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65162-027-096516200270990 CAPSULE in 1 BOTTLE (65162-027-09) 90 capsule2023-08-28NoNoCurrent