FDA.reportPublic FDA data

LISDEXAMFETAMINE DIMESYLATE

Product NDC
31722-322
11-digit product format
317220322
Labeler code
31722
Product ID
31722-322_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
20 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

Additional Listing Data#

Finished product
Yes
Brand name base
LISDEXAMFETAMINE DIMESYLATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LISDEXAMFETAMINE DIMESYLATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSJT761GEGS
Rxcui1871456, 1871460, 1871462, 1871464, 1871466, 1871468

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
31722-322-01LISDEXAMFETAMINE DIMESYLATE100 in 1 BOTTLETABLET, CHEWABLE1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-322-01EA - Each31722-3229845ef1f-70a0-4b58-9b17-f9ade7d16d7712024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-322LISDEXAMFETAMINE 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
31722-322-0131722032201100 TABLET, CHEWABLE in 1 BOTTLE (31722-322-01) 2023-08-25NoNoHistorical