FDA.reportPublic FDA data

Vyvanse

Product NDC
59417-117
11-digit product format
594170117
Labeler code
59417
Product ID
59417-117_81d087b6-4cb4-466a-9693-679edeb062e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LISDEXAMFETAMINE DIMESYLATE
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Takeda Pharmaceuticals America, Inc.
Application
NDA208510
Marketing category
NDA
Marketing start
2017-01-28
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LISDEXAMFETAMINE DIMESYLATE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSJT761GEGS
Rxcui854830, 854832, 854834, 854836, 854838, 854840, 854842, 854844, 854846, 854848, 854850, 854852, 1593856, 1593858, 1871456, 1871459, 1871460, 1871461, 1871462, 1871463

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
59417-117-01Vyvanse100 in 1 BOTTLETABLET, CHEWABLE10081

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59417-117-01EA - Each59417-117517140d1-2725-4ead-870b-cfc621f9aa8312017-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LISDEXAMFETAMINE DIMESYLATEACTIVE INGREDIENTSJT761GEGSVYVANSE (LISDEXAMFETAMINE DIMESYLATE) CAPSULE [SHIRE LLC]54
LISDEXAMFETAMINEACTIVE MOIETYH645GUL8KJVYVANSE (LISDEXAMFETAMINE DIMESYLATE) CAPSULE [SHIRE LLC]54
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVYVANSE (LISDEXAMFETAMINE DIMESYLATE) CAPSULE [SHIRE LLC]54
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48VYVANSE (LISDEXAMFETAMINE DIMESYLATE) CAPSULE [SHIRE LLC]54
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDVYVANSE (LISDEXAMFETAMINE DIMESYLATE) CAPSULE [SHIRE LLC]54
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYVYVANSE (LISDEXAMFETAMINE DIMESYLATE) CAPSULE [SHIRE LLC]54
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8VYVANSE (LISDEXAMFETAMINE DIMESYLATE) CAPSULE [SHIRE LLC]54
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTVYVANSE (LISDEXAMFETAMINE DIMESYLATE) CAPSULE [SHIRE LLC]54
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357VYVANSE (LISDEXAMFETAMINE DIMESYLATE) CAPSULE [SHIRE LLC]54
GELATININACTIVE INGREDIENT2G86QN327LVYVANSE (LISDEXAMFETAMINE DIMESYLATE) CAPSULE [SHIRE LLC]54
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VYVANSE (LISDEXAMFETAMINE DIMESYLATE) CAPSULE [SHIRE LLC]54
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVYVANSE (LISDEXAMFETAMINE DIMESYLATE) CAPSULE [SHIRE LLC]54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59417-117VYVANSE (LISDEXAMFETAMINE DIMESYLATE) CAPSULE VYVANSE (LISDEXAMFETAMINE DIMESYLATE) TABLET, CHEWABLE [TAKEDA PHARMACEUTICALS AMERICA, INC.]75Current NDC, Legacy NDC, 1 package rows20231024_704e4378-ca83-445c-8b45-3cfa51c1ecad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1871464lisdexamfetamine dimesylate 10 MG Chewable TabletPSN704e4378-ca83-445c-8b45-3cfa51c1ecad81
1593856lisdexamfetamine dimesylate 10 MG Oral CapsulePSN704e4378-ca83-445c-8b45-3cfa51c1ecad81
1871462lisdexamfetamine dimesylate 20 MG Chewable TabletPSN704e4378-ca83-445c-8b45-3cfa51c1ecad81
854830lisdexamfetamine dimesylate 20 MG Oral CapsulePSN704e4378-ca83-445c-8b45-3cfa51c1ecad81
1871460lisdexamfetamine dimesylate 30 MG Chewable TabletPSN704e4378-ca83-445c-8b45-3cfa51c1ecad81
854834lisdexamfetamine dimesylate 30 MG Oral CapsulePSN704e4378-ca83-445c-8b45-3cfa51c1ecad81
1871456lisdexamfetamine dimesylate 40 MG Chewable TabletPSN704e4378-ca83-445c-8b45-3cfa51c1ecad81
854838lisdexamfetamine dimesylate 40 MG Oral CapsulePSN704e4378-ca83-445c-8b45-3cfa51c1ecad81
1871468lisdexamfetamine dimesylate 50 MG Chewable TabletPSN704e4378-ca83-445c-8b45-3cfa51c1ecad81
854850lisdexamfetamine dimesylate 50 MG Oral CapsulePSN704e4378-ca83-445c-8b45-3cfa51c1ecad81
1871466lisdexamfetamine dimesylate 60 MG Chewable TabletPSN704e4378-ca83-445c-8b45-3cfa51c1ecad81
854846lisdexamfetamine dimesylate 60 MG Oral CapsulePSN704e4378-ca83-445c-8b45-3cfa51c1ecad81
854842lisdexamfetamine dimesylate 70 MG Oral CapsulePSN704e4378-ca83-445c-8b45-3cfa51c1ecad81
1871465Vyvanse 10 MG Chewable TabletPSN704e4378-ca83-445c-8b45-3cfa51c1ecad81
1593858Vyvanse 10 MG Oral CapsulePSN704e4378-ca83-445c-8b45-3cfa51c1ecad81
1871463Vyvanse 20 MG Chewable TabletPSN704e4378-ca83-445c-8b45-3cfa51c1ecad81
854832Vyvanse 20 MG Oral CapsulePSN704e4378-ca83-445c-8b45-3cfa51c1ecad81
1871461Vyvanse 30 MG Chewable TabletPSN704e4378-ca83-445c-8b45-3cfa51c1ecad81
854836Vyvanse 30 MG Oral CapsulePSN704e4378-ca83-445c-8b45-3cfa51c1ecad81
1871459Vyvanse 40 MG Chewable TabletPSN704e4378-ca83-445c-8b45-3cfa51c1ecad81
854840Vyvanse 40 MG Oral CapsulePSN704e4378-ca83-445c-8b45-3cfa51c1ecad81
1871469Vyvanse 50 MG Chewable TabletPSN704e4378-ca83-445c-8b45-3cfa51c1ecad81
854852Vyvanse 50 MG Oral CapsulePSN704e4378-ca83-445c-8b45-3cfa51c1ecad81
1871467Vyvanse 60 MG Chewable TabletPSN704e4378-ca83-445c-8b45-3cfa51c1ecad81
854848Vyvanse 60 MG Oral CapsulePSN704e4378-ca83-445c-8b45-3cfa51c1ecad81
854844Vyvanse 70 MG Oral CapsulePSN704e4378-ca83-445c-8b45-3cfa51c1ecad81
1871465lisdexamfetamine dimesylate 10 MG Chewable Tablet [Vyvanse]SBD704e4378-ca83-445c-8b45-3cfa51c1ecad81
1593858lisdexamfetamine dimesylate 10 MG Oral Capsule [Vyvanse]SBD704e4378-ca83-445c-8b45-3cfa51c1ecad81
1871463lisdexamfetamine dimesylate 20 MG Chewable Tablet [Vyvanse]SBD704e4378-ca83-445c-8b45-3cfa51c1ecad81
854832lisdexamfetamine dimesylate 20 MG Oral Capsule [Vyvanse]SBD704e4378-ca83-445c-8b45-3cfa51c1ecad81
1871461lisdexamfetamine dimesylate 30 MG Chewable Tablet [Vyvanse]SBD704e4378-ca83-445c-8b45-3cfa51c1ecad81
854836lisdexamfetamine dimesylate 30 MG Oral Capsule [Vyvanse]SBD704e4378-ca83-445c-8b45-3cfa51c1ecad81
1871459lisdexamfetamine dimesylate 40 MG Chewable Tablet [Vyvanse]SBD704e4378-ca83-445c-8b45-3cfa51c1ecad81
854840lisdexamfetamine dimesylate 40 MG Oral Capsule [Vyvanse]SBD704e4378-ca83-445c-8b45-3cfa51c1ecad81
1871469lisdexamfetamine dimesylate 50 MG Chewable Tablet [Vyvanse]SBD704e4378-ca83-445c-8b45-3cfa51c1ecad81
854852lisdexamfetamine dimesylate 50 MG Oral Capsule [Vyvanse]SBD704e4378-ca83-445c-8b45-3cfa51c1ecad81
1871467lisdexamfetamine dimesylate 60 MG Chewable Tablet [Vyvanse]SBD704e4378-ca83-445c-8b45-3cfa51c1ecad81
854848lisdexamfetamine dimesylate 60 MG Oral Capsule [Vyvanse]SBD704e4378-ca83-445c-8b45-3cfa51c1ecad81
854844lisdexamfetamine dimesylate 70 MG Oral Capsule [Vyvanse]SBD704e4378-ca83-445c-8b45-3cfa51c1ecad81
1871464lisdexamfetamine dimesylate 10 MG Chewable TabletSCD704e4378-ca83-445c-8b45-3cfa51c1ecad81
1593856lisdexamfetamine dimesylate 10 MG Oral CapsuleSCD704e4378-ca83-445c-8b45-3cfa51c1ecad81
1871462lisdexamfetamine dimesylate 20 MG Chewable TabletSCD704e4378-ca83-445c-8b45-3cfa51c1ecad81
854830lisdexamfetamine dimesylate 20 MG Oral CapsuleSCD704e4378-ca83-445c-8b45-3cfa51c1ecad81
1871460lisdexamfetamine dimesylate 30 MG Chewable TabletSCD704e4378-ca83-445c-8b45-3cfa51c1ecad81
854834lisdexamfetamine dimesylate 30 MG Oral CapsuleSCD704e4378-ca83-445c-8b45-3cfa51c1ecad81
1871456lisdexamfetamine dimesylate 40 MG Chewable TabletSCD704e4378-ca83-445c-8b45-3cfa51c1ecad81
854838lisdexamfetamine dimesylate 40 MG Oral CapsuleSCD704e4378-ca83-445c-8b45-3cfa51c1ecad81
1871468lisdexamfetamine dimesylate 50 MG Chewable TabletSCD704e4378-ca83-445c-8b45-3cfa51c1ecad81
854850lisdexamfetamine dimesylate 50 MG Oral CapsuleSCD704e4378-ca83-445c-8b45-3cfa51c1ecad81
1871466lisdexamfetamine dimesylate 60 MG Chewable TabletSCD704e4378-ca83-445c-8b45-3cfa51c1ecad81
854846lisdexamfetamine dimesylate 60 MG Oral CapsuleSCD704e4378-ca83-445c-8b45-3cfa51c1ecad81
854842lisdexamfetamine dimesylate 70 MG Oral CapsuleSCD704e4378-ca83-445c-8b45-3cfa51c1ecad81
1871465Vyvanse 10 MG Chewable TabletSY704e4378-ca83-445c-8b45-3cfa51c1ecad81
1593858Vyvanse 10 MG Oral CapsuleSY704e4378-ca83-445c-8b45-3cfa51c1ecad81
1871463Vyvanse 20 MG Chewable TabletSY704e4378-ca83-445c-8b45-3cfa51c1ecad81
854832Vyvanse 20 MG Oral CapsuleSY704e4378-ca83-445c-8b45-3cfa51c1ecad81
1871461Vyvanse 30 MG Chewable TabletSY704e4378-ca83-445c-8b45-3cfa51c1ecad81
854836Vyvanse 30 MG Oral CapsuleSY704e4378-ca83-445c-8b45-3cfa51c1ecad81
1871459Vyvanse 40 MG Chewable TabletSY704e4378-ca83-445c-8b45-3cfa51c1ecad81
854840Vyvanse 40 MG Oral CapsuleSY704e4378-ca83-445c-8b45-3cfa51c1ecad81
1871469Vyvanse 50 MG Chewable TabletSY704e4378-ca83-445c-8b45-3cfa51c1ecad81
854852Vyvanse 50 MG Oral CapsuleSY704e4378-ca83-445c-8b45-3cfa51c1ecad81
1871467Vyvanse 60 MG Chewable TabletSY704e4378-ca83-445c-8b45-3cfa51c1ecad81
854848Vyvanse 60 MG Oral CapsuleSY704e4378-ca83-445c-8b45-3cfa51c1ecad81
854844Vyvanse 70 MG Oral CapsuleSY704e4378-ca83-445c-8b45-3cfa51c1ecad81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59417-117-0159417011701100 TABLET, CHEWABLE in 1 BOTTLE (59417-117-01) 2017-01-280000-00-00NoNoCurrent