lisdexamfetamine dimesylate

Product NDC
0480-9742
11-digit product format
004809742
Labeler code
0480
Product ID
0480-9742_a9418850-010a-4fff-9aa7-d7167d58d8b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lisdexamfetamine dimesylate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Teva Pharmaceuticals, Inc.
Application
ANDA215415
Marketing category
ANDA
Marketing start
2024-09-16
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 42.

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
A215415-001LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE10MGTABLET, CHEWABLE / ORALAB2023-08-25
A215415-002LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE20MGTABLET, CHEWABLE / ORALAB2023-08-25
A215415-003LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE30MGTABLET, CHEWABLE / ORALAB2023-08-25
A215415-004LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE40MGTABLET, CHEWABLE / ORALAB2023-08-25
A215415-005LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE50MGTABLET, CHEWABLE / ORALAB2023-08-25
A215415-006LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE60MGTABLET, CHEWABLE / 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
A215415-001AB
A215415-002AB
A215415-003AB
A215415-004AB
A215415-005AB
A215415-006AB

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.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A215415-001LISDEXAMFETAMINE DIMESYLATE10MGTABLET, CHEWABLE / ORALAB2023-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A215415-002LISDEXAMFETAMINE DIMESYLATE20MGTABLET, CHEWABLE / ORALAB2023-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A215415-003LISDEXAMFETAMINE DIMESYLATE30MGTABLET, CHEWABLE / ORALAB2023-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A215415-004LISDEXAMFETAMINE DIMESYLATE40MGTABLET, CHEWABLE / ORALAB2023-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A215415-005LISDEXAMFETAMINE DIMESYLATE50MGTABLET, CHEWABLE / ORALAB2023-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A215415-006LISDEXAMFETAMINE DIMESYLATE60MGTABLET, CHEWABLE / ORALAB2023-08-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215415-001LISDEXAMFETAMINE DIMESYLATE10MGTABLET, CHEWABLE / ORALAB2023-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215415-002LISDEXAMFETAMINE DIMESYLATE20MGTABLET, CHEWABLE / ORALAB2023-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215415-003LISDEXAMFETAMINE DIMESYLATE30MGTABLET, CHEWABLE / ORALAB2023-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215415-004LISDEXAMFETAMINE DIMESYLATE40MGTABLET, CHEWABLE / ORALAB2023-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215415-005LISDEXAMFETAMINE DIMESYLATE50MGTABLET, CHEWABLE / ORALAB2023-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215415-006LISDEXAMFETAMINE DIMESYLATE60MGTABLET, CHEWABLE / ORALAB2023-08-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215415-001LISDEXAMFETAMINE DIMESYLATE10MGTABLET, CHEWABLE / ORALAB2023-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215415-002LISDEXAMFETAMINE DIMESYLATE20MGTABLET, CHEWABLE / ORALAB2023-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215415-003LISDEXAMFETAMINE DIMESYLATE30MGTABLET, CHEWABLE / ORALAB2023-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215415-004LISDEXAMFETAMINE DIMESYLATE40MGTABLET, CHEWABLE / ORALAB2023-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215415-005LISDEXAMFETAMINE DIMESYLATE50MGTABLET, CHEWABLE / ORALAB2023-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215415-006LISDEXAMFETAMINE DIMESYLATE60MGTABLET, CHEWABLE / ORALAB2023-08-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A215415-001LISDEXAMFETAMINE DIMESYLATE10MGTABLET, CHEWABLE / ORALAB2023-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215415-002LISDEXAMFETAMINE DIMESYLATE20MGTABLET, CHEWABLE / ORALAB2023-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215415-003LISDEXAMFETAMINE DIMESYLATE30MGTABLET, CHEWABLE / ORALAB2023-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215415-004LISDEXAMFETAMINE DIMESYLATE40MGTABLET, CHEWABLE / ORALAB2023-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215415-005LISDEXAMFETAMINE DIMESYLATE50MGTABLET, CHEWABLE / ORALAB2023-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215415-006LISDEXAMFETAMINE DIMESYLATE60MGTABLET, CHEWABLE / ORALAB2023-08-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215415-001LISDEXAMFETAMINE DIMESYLATE10MGTABLET, CHEWABLE / ORALAB2023-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215415-002LISDEXAMFETAMINE DIMESYLATE20MGTABLET, CHEWABLE / ORALAB2023-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215415-003LISDEXAMFETAMINE DIMESYLATE30MGTABLET, CHEWABLE / ORALAB2023-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215415-004LISDEXAMFETAMINE DIMESYLATE40MGTABLET, CHEWABLE / ORALAB2023-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215415-005LISDEXAMFETAMINE DIMESYLATE50MGTABLET, CHEWABLE / ORALAB2023-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215415-006LISDEXAMFETAMINE DIMESYLATE60MGTABLET, CHEWABLE / ORALAB2023-08-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215415-001LISDEXAMFETAMINE DIMESYLATE10MGTABLET, CHEWABLE / ORALAB2023-08-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215415-002LISDEXAMFETAMINE DIMESYLATE20MGTABLET, CHEWABLE / ORALAB2023-08-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215415-003LISDEXAMFETAMINE DIMESYLATE30MGTABLET, CHEWABLE / ORALAB2023-08-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215415-004LISDEXAMFETAMINE DIMESYLATE40MGTABLET, CHEWABLE / ORALAB2023-08-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215415-005LISDEXAMFETAMINE DIMESYLATE50MGTABLET, CHEWABLE / ORALAB2023-08-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215415-006LISDEXAMFETAMINE DIMESYLATE60MGTABLET, CHEWABLE / ORALAB2023-08-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215415-001LISDEXAMFETAMINE DIMESYLATE10MGTABLET, CHEWABLE / ORALAB2023-08-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215415-002LISDEXAMFETAMINE DIMESYLATE20MGTABLET, CHEWABLE / ORALAB2023-08-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215415-003LISDEXAMFETAMINE DIMESYLATE30MGTABLET, CHEWABLE / ORALAB2023-08-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215415-004LISDEXAMFETAMINE DIMESYLATE40MGTABLET, CHEWABLE / ORALAB2023-08-2503ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A215415-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215415-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215415-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215415-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215415-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215415-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215415-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215415-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215415-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215415-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215415-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215415-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215415-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215415-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215415-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215415-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215415-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215415-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215415-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215415-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215415-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215415-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215415-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215415-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215415-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215415-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215415-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215415-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215415-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215415-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215415-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215415-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215415-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215415-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215415-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215415-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215415-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215415-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215415-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215415-004AB103ed91905a0d…

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 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1871456Internal RxNorm lookup
1871460Internal RxNorm lookup
1871462Internal RxNorm lookup
1871464Internal RxNorm lookup
1871466Internal RxNorm lookup
1871468Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bdb03bfa-0398-41e5-8e73-ded696cbca32Available 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
0480-9742-01lisdexamfetamine dimesylate100 in 1 BOTTLETABLET, CHEWABLE1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0480-9742-01EA - Each0480-9742d4628963-f564-470b-9483-187bdfb4e7e812024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0480-9742LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE [TEVA PHARMACEUTICALS, INC.]1Current NDC, 1 package rows20240918_bdb03bfa-0398-41e5-8e73-ded696cbca32.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
lisdexamfetamine dimesylateLISDEXAMFETAMINE DIMESYLATETeva Pharmaceuticals, Inc.bdb03bfa-0398-41e5-8e73-ded696cbca322026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215415
application number: ANDA215415
ndc (product): 0480-9742

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0480-9742-0100480974201100 TABLET, CHEWABLE in 1 BOTTLE (0480-9742-01) 2024-09-16NoNoCurrent