FDA.reportPublic FDA data

LISDEXAMFETAMINE DIMESYLATE

Product NDC
31722-324
11-digit product format
317220324
Labeler code
31722
Product ID
31722-324_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
40 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 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
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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A217068-001LISDEXAMFETAMINE DIMESYLATE10MGTABLET, CHEWABLE / ORALAB2023-08-25a50c72e98297…
2026-08-01 22:54:322026-06A217068-002LISDEXAMFETAMINE DIMESYLATE20MGTABLET, CHEWABLE / ORALAB2023-08-25a50c72e98297…
2026-08-01 22:54:322026-06A217068-003LISDEXAMFETAMINE DIMESYLATE30MGTABLET, CHEWABLE / ORALAB2023-08-25a50c72e98297…
2026-08-01 22:54:322026-06A217068-004LISDEXAMFETAMINE DIMESYLATE40MGTABLET, CHEWABLE / ORALAB2023-08-25a50c72e98297…
2026-08-01 22:54:322026-06A217068-005LISDEXAMFETAMINE DIMESYLATE50MGTABLET, CHEWABLE / ORALAB2023-08-25a50c72e98297…
2026-08-01 22:54:322026-06A217068-006LISDEXAMFETAMINE DIMESYLATE60MGTABLET, CHEWABLE / ORALAB2023-08-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A217068-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A217068-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A217068-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A217068-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A217068-005AB1a50c72e98297…
2026-08-01 22:54:322026-06A217068-006AB1a50c72e98297…

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 · 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): 31722-324

Additional Listing Data#

Finished product
Yes
Brand name base
LISDEXAMFETAMINE DIMESYLATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LISDEXAMFETAMINE DIMESYLATE40 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
31722-324-01LISDEXAMFETAMINE DIMESYLATE100 in 1 BOTTLETABLET, CHEWABLE1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-324-01EA - Each31722-324f811b4cc-427f-4698-92a1-3c66f5a1dfdc12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-324LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE [CAMBER PHARMACEUTICALS, INC.]1Current NDC, 1 package rows20240925_f05bac63-08a5-49ce-8180-b33b76c0c0c4.zip

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
31722-324-0131722032401100 TABLET, CHEWABLE in 1 BOTTLE (31722-324-01) 2023-08-25NoNoCurrent