lisdexamfetamine dimesylate

Product NDC
72162-2216
Requested package NDC
72162-2216-1
11-digit product format
721622216
Labeler code
72162
Product ID
72162-2216_a0de8320-488d-4cd2-b976-68067f7222fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lisdexamfetamine dimesylate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA214547
Marketing category
ANDA
Marketing start
2023-08-25
Substance
LISDEXAMFETAMINE DIMESYLATE
Active strength
30 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 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
A214547-001LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE10MGCAPSULE / ORALAB2023-08-25
A214547-002LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE20MGCAPSULE / ORALAB2023-08-25
A214547-003LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE30MGCAPSULE / ORALAB2023-08-25
A214547-004LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE40MGCAPSULE / ORALAB2023-08-25
A214547-005LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE50MGCAPSULE / ORALAB2023-08-25
A214547-006LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE60MGCAPSULE / ORALAB2023-08-25
A214547-007LISDEXAMFETAMINE 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
A214547-001AB
A214547-002AB
A214547-003AB
A214547-004AB
A214547-005AB
A214547-006AB
A214547-007AB

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 22:38:342026-08A214547-001LISDEXAMFETAMINE DIMESYLATE10MGCAPSULE / ORALAB2023-08-2584e616aacf4f…
2026-09-14 22:38:342026-08A214547-002LISDEXAMFETAMINE DIMESYLATE20MGCAPSULE / ORALAB2023-08-2584e616aacf4f…
2026-09-14 22:38:342026-08A214547-003LISDEXAMFETAMINE DIMESYLATE30MGCAPSULE / ORALAB2023-08-2584e616aacf4f…
2026-09-14 22:38:342026-08A214547-004LISDEXAMFETAMINE DIMESYLATE40MGCAPSULE / ORALAB2023-08-2584e616aacf4f…
2026-09-14 22:38:342026-08A214547-005LISDEXAMFETAMINE DIMESYLATE50MGCAPSULE / ORALAB2023-08-2584e616aacf4f…
2026-09-14 22:38:342026-08A214547-006LISDEXAMFETAMINE DIMESYLATE60MGCAPSULE / ORALAB2023-08-2584e616aacf4f…
2026-09-14 22:38:342026-08A214547-007LISDEXAMFETAMINE DIMESYLATE70MGCAPSULE / ORALAB2023-08-2584e616aacf4f…
2026-08-18 06:07:402026-07A214547-001LISDEXAMFETAMINE DIMESYLATE10MGCAPSULE / ORALAB2023-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A214547-002LISDEXAMFETAMINE DIMESYLATE20MGCAPSULE / ORALAB2023-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A214547-003LISDEXAMFETAMINE DIMESYLATE30MGCAPSULE / ORALAB2023-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A214547-004LISDEXAMFETAMINE DIMESYLATE40MGCAPSULE / ORALAB2023-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A214547-005LISDEXAMFETAMINE DIMESYLATE50MGCAPSULE / ORALAB2023-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A214547-006LISDEXAMFETAMINE DIMESYLATE60MGCAPSULE / ORALAB2023-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A214547-007LISDEXAMFETAMINE DIMESYLATE70MGCAPSULE / ORALAB2023-08-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214547-001LISDEXAMFETAMINE DIMESYLATE10MGCAPSULE / ORALAB2023-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214547-002LISDEXAMFETAMINE DIMESYLATE20MGCAPSULE / ORALAB2023-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214547-003LISDEXAMFETAMINE DIMESYLATE30MGCAPSULE / ORALAB2023-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214547-004LISDEXAMFETAMINE DIMESYLATE40MGCAPSULE / ORALAB2023-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214547-005LISDEXAMFETAMINE DIMESYLATE50MGCAPSULE / ORALAB2023-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214547-006LISDEXAMFETAMINE DIMESYLATE60MGCAPSULE / ORALAB2023-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214547-007LISDEXAMFETAMINE DIMESYLATE70MGCAPSULE / ORALAB2023-08-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214547-001LISDEXAMFETAMINE DIMESYLATE10MGCAPSULE / ORALAB2023-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214547-002LISDEXAMFETAMINE DIMESYLATE20MGCAPSULE / ORALAB2023-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214547-003LISDEXAMFETAMINE DIMESYLATE30MGCAPSULE / ORALAB2023-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214547-004LISDEXAMFETAMINE DIMESYLATE40MGCAPSULE / ORALAB2023-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214547-005LISDEXAMFETAMINE DIMESYLATE50MGCAPSULE / ORALAB2023-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214547-006LISDEXAMFETAMINE DIMESYLATE60MGCAPSULE / ORALAB2023-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214547-007LISDEXAMFETAMINE DIMESYLATE70MGCAPSULE / ORALAB2023-08-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A214547-001LISDEXAMFETAMINE DIMESYLATE10MGCAPSULE / ORALAB2023-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214547-002LISDEXAMFETAMINE DIMESYLATE20MGCAPSULE / ORALAB2023-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214547-003LISDEXAMFETAMINE DIMESYLATE30MGCAPSULE / ORALAB2023-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214547-004LISDEXAMFETAMINE DIMESYLATE40MGCAPSULE / ORALAB2023-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214547-005LISDEXAMFETAMINE DIMESYLATE50MGCAPSULE / ORALAB2023-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214547-006LISDEXAMFETAMINE DIMESYLATE60MGCAPSULE / ORALAB2023-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214547-007LISDEXAMFETAMINE DIMESYLATE70MGCAPSULE / ORALAB2023-08-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214547-001LISDEXAMFETAMINE DIMESYLATE10MGCAPSULE / ORALAB2023-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214547-002LISDEXAMFETAMINE DIMESYLATE20MGCAPSULE / ORALAB2023-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214547-003LISDEXAMFETAMINE DIMESYLATE30MGCAPSULE / ORALAB2023-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214547-004LISDEXAMFETAMINE DIMESYLATE40MGCAPSULE / ORALAB2023-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214547-005LISDEXAMFETAMINE 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 22:38:342026-08A214547-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A214547-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A214547-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A214547-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A214547-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A214547-006AB184e616aacf4f…
2026-09-14 22:38:342026-08A214547-007AB184e616aacf4f…
2026-08-18 06:07:402026-07A214547-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A214547-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A214547-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A214547-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A214547-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A214547-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A214547-007AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214547-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214547-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214547-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214547-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214547-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214547-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214547-007AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214547-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214547-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214547-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214547-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214547-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214547-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214547-007AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214547-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214547-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214547-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214547-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214547-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214547-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214547-007AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214547-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214547-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214547-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214547-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214547-005AB1fd3edfee7708…

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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LISDEXAMFETAMINE DIMESYLATE30 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
854834Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7d80e121-88d4-4e65-b60e-05e713368d4bAvailable 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
72162-2216-1lisdexamfetamine dimesylate100 in 1 BOTTLECAPSULE100100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2216-1EA - Each72162-221635034ea3-a28c-4a33-a873-0f5f852585b412024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2216LISDEXAMFETAMINE DIMESYLATE CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20240106_7d80e121-88d4-4e65-b60e-05e713368d4b.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
lisdexamfetamine dimesylateLISDEXAMFETAMINE DIMESYLATEAlvogen Inc.7f2dd6ee-3363-c87c-9693-ed838942556c2026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214547
application number: ANDA214547
lisdexamfetamine dimesylateLISDEXAMFETAMINE DIMESYLATEBryant Ranch Prepack7d80e121-88d4-4e65-b60e-05e713368d4b2024-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214547
application number: ANDA214547
ndc (package): 72162-2216-1
ndc (product): 72162-2216
ndc11 (package): 72162221601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854834lisdexamfetamine dimesylate 30 MG Oral CapsulePSN7d80e121-88d4-4e65-b60e-05e713368d4b100
854834lisdexamfetamine dimesylate 30 MG Oral CapsuleSCD7d80e121-88d4-4e65-b60e-05e713368d4b100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2216-172162221601100 CAPSULE in 1 BOTTLE (72162-2216-1) 100 capsule2024-01-05NoNoCurrent