LISDEXAMFETAMINE DIMESYLATE

Product NDC
31722-326
11-digit product format
317220326
Labeler code
31722
Product ID
31722-326_37397df5-ba32-4489-a34b-81a61f5b860d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lisdexamfetamine dimesylate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA217068
Marketing category
ANDA
Marketing start
2023-08-25
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
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
A217068-001LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE10MGTABLET, CHEWABLE / ORALAB2023-08-25
A217068-002LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE20MGTABLET, CHEWABLE / ORALAB2023-08-25
A217068-003LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE30MGTABLET, CHEWABLE / ORALAB2023-08-25
A217068-004LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE40MGTABLET, CHEWABLE / ORALAB2023-08-25
A217068-005LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE50MGTABLET, CHEWABLE / ORALAB2023-08-25
A217068-006LISDEXAMFETAMINE 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
A217068-001AB
A217068-002AB
A217068-003AB
A217068-004AB
A217068-005AB
A217068-006AB

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 06:07:402026-07A217068-001LISDEXAMFETAMINE DIMESYLATE10MGTABLET, CHEWABLE / ORALAB2023-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A217068-002LISDEXAMFETAMINE DIMESYLATE20MGTABLET, CHEWABLE / ORALAB2023-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A217068-003LISDEXAMFETAMINE DIMESYLATE30MGTABLET, CHEWABLE / ORALAB2023-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A217068-004LISDEXAMFETAMINE DIMESYLATE40MGTABLET, CHEWABLE / ORALAB2023-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A217068-005LISDEXAMFETAMINE DIMESYLATE50MGTABLET, CHEWABLE / ORALAB2023-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A217068-006LISDEXAMFETAMINE DIMESYLATE60MGTABLET, CHEWABLE / ORALAB2023-08-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217068-001LISDEXAMFETAMINE DIMESYLATE10MGTABLET, CHEWABLE / ORALAB2023-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217068-002LISDEXAMFETAMINE DIMESYLATE20MGTABLET, CHEWABLE / ORALAB2023-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217068-003LISDEXAMFETAMINE DIMESYLATE30MGTABLET, CHEWABLE / ORALAB2023-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217068-004LISDEXAMFETAMINE DIMESYLATE40MGTABLET, CHEWABLE / ORALAB2023-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217068-005LISDEXAMFETAMINE DIMESYLATE50MGTABLET, CHEWABLE / ORALAB2023-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217068-006LISDEXAMFETAMINE DIMESYLATE60MGTABLET, CHEWABLE / ORALAB2023-08-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217068-001LISDEXAMFETAMINE DIMESYLATE10MGTABLET, CHEWABLE / ORALAB2023-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217068-002LISDEXAMFETAMINE DIMESYLATE20MGTABLET, CHEWABLE / ORALAB2023-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217068-003LISDEXAMFETAMINE DIMESYLATE30MGTABLET, CHEWABLE / ORALAB2023-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217068-004LISDEXAMFETAMINE DIMESYLATE40MGTABLET, CHEWABLE / ORALAB2023-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217068-005LISDEXAMFETAMINE DIMESYLATE50MGTABLET, CHEWABLE / ORALAB2023-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217068-006LISDEXAMFETAMINE DIMESYLATE60MGTABLET, CHEWABLE / ORALAB2023-08-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A217068-001LISDEXAMFETAMINE DIMESYLATE10MGTABLET, CHEWABLE / ORALAB2023-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217068-002LISDEXAMFETAMINE DIMESYLATE20MGTABLET, CHEWABLE / ORALAB2023-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217068-003LISDEXAMFETAMINE DIMESYLATE30MGTABLET, CHEWABLE / ORALAB2023-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217068-004LISDEXAMFETAMINE DIMESYLATE40MGTABLET, CHEWABLE / ORALAB2023-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217068-005LISDEXAMFETAMINE DIMESYLATE50MGTABLET, CHEWABLE / ORALAB2023-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217068-006LISDEXAMFETAMINE DIMESYLATE60MGTABLET, CHEWABLE / ORALAB2023-08-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217068-001LISDEXAMFETAMINE DIMESYLATE10MGTABLET, CHEWABLE / ORALAB2023-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217068-002LISDEXAMFETAMINE DIMESYLATE20MGTABLET, CHEWABLE / ORALAB2023-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217068-003LISDEXAMFETAMINE DIMESYLATE30MGTABLET, CHEWABLE / ORALAB2023-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217068-004LISDEXAMFETAMINE DIMESYLATE40MGTABLET, CHEWABLE / ORALAB2023-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217068-005LISDEXAMFETAMINE DIMESYLATE50MGTABLET, CHEWABLE / ORALAB2023-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217068-006LISDEXAMFETAMINE DIMESYLATE60MGTABLET, CHEWABLE / ORALAB2023-08-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217068-001LISDEXAMFETAMINE DIMESYLATE10MGTABLET, CHEWABLE / ORALAB2023-08-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217068-002LISDEXAMFETAMINE DIMESYLATE20MGTABLET, CHEWABLE / ORALAB2023-08-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217068-003LISDEXAMFETAMINE DIMESYLATE30MGTABLET, CHEWABLE / ORALAB2023-08-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217068-004LISDEXAMFETAMINE DIMESYLATE40MGTABLET, CHEWABLE / ORALAB2023-08-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217068-005LISDEXAMFETAMINE DIMESYLATE50MGTABLET, CHEWABLE / ORALAB2023-08-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217068-006LISDEXAMFETAMINE DIMESYLATE60MGTABLET, CHEWABLE / ORALAB2023-08-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217068-001LISDEXAMFETAMINE DIMESYLATE10MGTABLET, CHEWABLE / ORALAB2023-08-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217068-002LISDEXAMFETAMINE DIMESYLATE20MGTABLET, CHEWABLE / ORALAB2023-08-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217068-003LISDEXAMFETAMINE DIMESYLATE30MGTABLET, CHEWABLE / ORALAB2023-08-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217068-004LISDEXAMFETAMINE DIMESYLATE40MGTABLET, CHEWABLE / ORALAB2023-08-2503ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A217068-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A217068-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A217068-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A217068-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A217068-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A217068-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217068-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217068-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217068-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217068-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217068-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217068-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217068-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217068-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217068-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217068-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217068-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217068-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217068-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217068-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217068-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217068-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217068-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217068-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217068-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217068-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217068-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217068-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217068-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217068-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217068-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217068-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217068-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217068-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217068-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217068-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217068-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217068-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217068-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217068-004AB103ed91905a0d…

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
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
f05bac63-08a5-49ce-8180-b33b76c0c0c4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb29ac3a-860f-7ed2-7559-c97af4af1704Product name320250603
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-326-01LISDEXAMFETAMINE DIMESYLATE100 in 1 BOTTLETABLET, CHEWABLE1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-326-01EA - Each31722-326a9de0ac9-b74c-4286-bc01-88ab52a7b8c112024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-326LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE [CAMBER PHARMACEUTICALS, INC.]1Current NDC, 1 package rows20240925_f05bac63-08a5-49ce-8180-b33b76c0c0c4.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 DIMESYLATECamber Pharmaceuticals, Inc.f05bac63-08a5-49ce-8180-b33b76c0c0c42026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217068
application number: ANDA217068
ndc (product): 31722-326

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1871464lisdexamfetamine dimesylate 10 MG Chewable TabletPSNf05bac63-08a5-49ce-8180-b33b76c0c0c41
1871462lisdexamfetamine dimesylate 20 MG Chewable TabletPSNf05bac63-08a5-49ce-8180-b33b76c0c0c41
1871460lisdexamfetamine dimesylate 30 MG Chewable TabletPSNf05bac63-08a5-49ce-8180-b33b76c0c0c41
1871456lisdexamfetamine dimesylate 40 MG Chewable TabletPSNf05bac63-08a5-49ce-8180-b33b76c0c0c41
1871468lisdexamfetamine dimesylate 50 MG Chewable TabletPSNf05bac63-08a5-49ce-8180-b33b76c0c0c41
1871466lisdexamfetamine dimesylate 60 MG Chewable TabletPSNf05bac63-08a5-49ce-8180-b33b76c0c0c41
1871464lisdexamfetamine dimesylate 10 MG Chewable TabletSCDf05bac63-08a5-49ce-8180-b33b76c0c0c41
1871462lisdexamfetamine dimesylate 20 MG Chewable TabletSCDf05bac63-08a5-49ce-8180-b33b76c0c0c41
1871460lisdexamfetamine dimesylate 30 MG Chewable TabletSCDf05bac63-08a5-49ce-8180-b33b76c0c0c41
1871456lisdexamfetamine dimesylate 40 MG Chewable TabletSCDf05bac63-08a5-49ce-8180-b33b76c0c0c41
1871468lisdexamfetamine dimesylate 50 MG Chewable TabletSCDf05bac63-08a5-49ce-8180-b33b76c0c0c41
1871466lisdexamfetamine dimesylate 60 MG Chewable TabletSCDf05bac63-08a5-49ce-8180-b33b76c0c0c41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
31722-326-0131722032601100 TABLET, CHEWABLE in 1 BOTTLE (31722-326-01) 2023-08-25NoNoCurrent