FDA.reportPublic FDA data

Lisdexamfetamine Dimesylate

Product NDC
0527-4661
11-digit product format
005274661
Labeler code
0527
Product ID
0527-4661_164b5658-3c14-44f5-b10a-839909184984
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisdexamfetamine Dimesylate
Dosage form
CAPSULE
Route
ORAL
Labeler
Lannett Company, LLC
Application
ANDA215802
Marketing category
ANDA
Marketing start
2023-08-25
Substance
LISDEXAMFETAMINE DIMESYLATE
Active strength
10 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 43.

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
A215802-001LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE10MGCAPSULE / ORALAB2023-08-25
A215802-002LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE20MGCAPSULE / ORALAB2023-08-25
A215802-003LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE30MGCAPSULE / ORALAB2023-08-25
A215802-004LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE40MGCAPSULE / ORALAB2023-08-25
A215802-005LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE50MGCAPSULE / ORALAB2023-08-25
A215802-006LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE60MGCAPSULE / ORALAB2023-08-25
A215802-007LISDEXAMFETAMINE 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
A215802-001AB
A215802-002AB
A215802-003AB
A215802-004AB
A215802-005AB
A215802-006AB
A215802-007AB

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.

Product history page 1 of 4 · 154 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A215802-001LISDEXAMFETAMINE DIMESYLATE10MGCAPSULE / ORALAB2023-08-2584e616aacf4f…
2026-09-14 22:38:342026-08A215802-002LISDEXAMFETAMINE DIMESYLATE20MGCAPSULE / ORALAB2023-08-2584e616aacf4f…
2026-09-14 22:38:342026-08A215802-003LISDEXAMFETAMINE DIMESYLATE30MGCAPSULE / ORALAB2023-08-2584e616aacf4f…
2026-09-14 22:38:342026-08A215802-004LISDEXAMFETAMINE DIMESYLATE40MGCAPSULE / ORALAB2023-08-2584e616aacf4f…
2026-09-14 22:38:342026-08A215802-005LISDEXAMFETAMINE DIMESYLATE50MGCAPSULE / ORALAB2023-08-2584e616aacf4f…
2026-09-14 22:38:342026-08A215802-006LISDEXAMFETAMINE DIMESYLATE60MGCAPSULE / ORALAB2023-08-2584e616aacf4f…
2026-09-14 22:38:342026-08A215802-007LISDEXAMFETAMINE DIMESYLATE70MGCAPSULE / ORALAB2023-08-2584e616aacf4f…
2026-08-18 06:07:402026-07A215802-001LISDEXAMFETAMINE DIMESYLATE10MGCAPSULE / ORALAB2023-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A215802-002LISDEXAMFETAMINE DIMESYLATE20MGCAPSULE / ORALAB2023-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A215802-003LISDEXAMFETAMINE DIMESYLATE30MGCAPSULE / ORALAB2023-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A215802-004LISDEXAMFETAMINE DIMESYLATE40MGCAPSULE / ORALAB2023-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A215802-005LISDEXAMFETAMINE DIMESYLATE50MGCAPSULE / ORALAB2023-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A215802-006LISDEXAMFETAMINE DIMESYLATE60MGCAPSULE / ORALAB2023-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A215802-007LISDEXAMFETAMINE DIMESYLATE70MGCAPSULE / ORALAB2023-08-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215802-001LISDEXAMFETAMINE DIMESYLATE10MGCAPSULE / ORALAB2023-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215802-002LISDEXAMFETAMINE DIMESYLATE20MGCAPSULE / ORALAB2023-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215802-003LISDEXAMFETAMINE DIMESYLATE30MGCAPSULE / ORALAB2023-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215802-004LISDEXAMFETAMINE DIMESYLATE40MGCAPSULE / ORALAB2023-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215802-005LISDEXAMFETAMINE DIMESYLATE50MGCAPSULE / ORALAB2023-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215802-006LISDEXAMFETAMINE DIMESYLATE60MGCAPSULE / ORALAB2023-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215802-007LISDEXAMFETAMINE DIMESYLATE70MGCAPSULE / ORALAB2023-08-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215802-001LISDEXAMFETAMINE DIMESYLATE10MGCAPSULE / ORALAB2023-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215802-002LISDEXAMFETAMINE DIMESYLATE20MGCAPSULE / ORALAB2023-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215802-003LISDEXAMFETAMINE DIMESYLATE30MGCAPSULE / ORALAB2023-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215802-004LISDEXAMFETAMINE DIMESYLATE40MGCAPSULE / ORALAB2023-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215802-005LISDEXAMFETAMINE DIMESYLATE50MGCAPSULE / ORALAB2023-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215802-006LISDEXAMFETAMINE DIMESYLATE60MGCAPSULE / ORALAB2023-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215802-007LISDEXAMFETAMINE DIMESYLATE70MGCAPSULE / ORALAB2023-08-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A215802-001LISDEXAMFETAMINE DIMESYLATE10MGCAPSULE / ORALAB2023-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215802-002LISDEXAMFETAMINE DIMESYLATE20MGCAPSULE / ORALAB2023-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215802-003LISDEXAMFETAMINE DIMESYLATE30MGCAPSULE / ORALAB2023-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215802-004LISDEXAMFETAMINE DIMESYLATE40MGCAPSULE / ORALAB2023-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215802-005LISDEXAMFETAMINE DIMESYLATE50MGCAPSULE / ORALAB2023-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215802-006LISDEXAMFETAMINE DIMESYLATE60MGCAPSULE / ORALAB2023-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215802-007LISDEXAMFETAMINE DIMESYLATE70MGCAPSULE / ORALAB2023-08-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215802-001LISDEXAMFETAMINE DIMESYLATE10MGCAPSULE / ORALAB2023-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215802-002LISDEXAMFETAMINE DIMESYLATE20MGCAPSULE / ORALAB2023-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215802-003LISDEXAMFETAMINE DIMESYLATE30MGCAPSULE / ORALAB2023-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215802-004LISDEXAMFETAMINE DIMESYLATE40MGCAPSULE / ORALAB2023-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215802-005LISDEXAMFETAMINE DIMESYLATE50MGCAPSULE / ORALAB2023-08-25fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 154 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A215802-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A215802-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A215802-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A215802-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A215802-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A215802-006AB184e616aacf4f…
2026-09-14 22:38:342026-08A215802-007AB184e616aacf4f…
2026-08-18 06:07:402026-07A215802-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215802-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215802-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215802-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215802-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215802-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215802-007AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215802-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215802-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215802-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215802-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215802-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215802-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215802-007AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215802-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215802-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215802-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215802-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215802-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215802-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215802-007AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215802-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215802-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215802-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215802-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215802-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215802-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215802-007AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215802-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215802-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215802-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215802-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215802-005AB1fd3edfee7708…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LISDEXAMFETAMINE DIMESYLATE10 mg/1

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
0527-4661-37Lisdexamfetamine Dimesylate100 in 1 BOTTLECAPSULE10019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-4661-37EA - Each0527-46612c44c7f8-607e-47ed-b500-79f7d341176312023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-4661LISDEXAMFETAMINE DIMESYLATE CAPSULE [LANNETT COMPANY, INC.]17Current NDC, 1 package rows20231110_2cedb4c2-1e40-4bc4-b9f4-127150c4afbd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1593856lisdexamfetamine dimesylate 10 MG Oral CapsulePSN2cedb4c2-1e40-4bc4-b9f4-127150c4afbd19
854830lisdexamfetamine dimesylate 20 MG Oral CapsulePSN2cedb4c2-1e40-4bc4-b9f4-127150c4afbd19
854834lisdexamfetamine dimesylate 30 MG Oral CapsulePSN2cedb4c2-1e40-4bc4-b9f4-127150c4afbd19
854838lisdexamfetamine dimesylate 40 MG Oral CapsulePSN2cedb4c2-1e40-4bc4-b9f4-127150c4afbd19
854850lisdexamfetamine dimesylate 50 MG Oral CapsulePSN2cedb4c2-1e40-4bc4-b9f4-127150c4afbd19
854846lisdexamfetamine dimesylate 60 MG Oral CapsulePSN2cedb4c2-1e40-4bc4-b9f4-127150c4afbd19
854842lisdexamfetamine dimesylate 70 MG Oral CapsulePSN2cedb4c2-1e40-4bc4-b9f4-127150c4afbd19
1593856lisdexamfetamine dimesylate 10 MG Oral CapsuleSCD2cedb4c2-1e40-4bc4-b9f4-127150c4afbd19
854830lisdexamfetamine dimesylate 20 MG Oral CapsuleSCD2cedb4c2-1e40-4bc4-b9f4-127150c4afbd19
854834lisdexamfetamine dimesylate 30 MG Oral CapsuleSCD2cedb4c2-1e40-4bc4-b9f4-127150c4afbd19
854838lisdexamfetamine dimesylate 40 MG Oral CapsuleSCD2cedb4c2-1e40-4bc4-b9f4-127150c4afbd19
854850lisdexamfetamine dimesylate 50 MG Oral CapsuleSCD2cedb4c2-1e40-4bc4-b9f4-127150c4afbd19
854846lisdexamfetamine dimesylate 60 MG Oral CapsuleSCD2cedb4c2-1e40-4bc4-b9f4-127150c4afbd19
854842lisdexamfetamine dimesylate 70 MG Oral CapsuleSCD2cedb4c2-1e40-4bc4-b9f4-127150c4afbd19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0527-4661-3700527466137100 CAPSULE in 1 BOTTLE (0527-4661-37) 100 capsule2023-08-25NoNoCurrent