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Lisdexamfetamine Dimesylate Tablet, Chewable

Takeda Pharmaceuticals USA Inc. · Available

Current59417-118-01Psychiatry
Open FDA's page for this record
Update type
Reverified
Initial posting date
07/14/2023
Package NDC
59417-118-01
Generic name
Lisdexamfetamine Dimesylate Tablet, Chewable
Contact info
877-TAKEDA-7 (1-877-825-3327)
Availability
Available
Update date
09/15/2026
Dosage form
Tablet, Chewable
Presentation
Vyvanse, Tablet, Chewable, 40 mg (NDC 59417-118-01)
Company name
Takeda Pharmaceuticals USA Inc.
Status
Current
Therapeutic category
Psychiatry
Harmonized identifiers (openFDA)
Application number
NDA208510
Brand name
VYVANSE
Generic name
LISDEXAMFETAMINE DIMESYLATE
Manufacturer name
Takeda Pharmaceuticals America, Inc.
Product NDC
59417-118, 59417-101, 59417-102, 59417-103, 59417-104, 59417-105, 59417-106, 59417-107, 59417-115, 59417-116, 59417-117, 59417-119, 59417-120
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
LISDEXAMFETAMINE DIMESYLATE
RxCUI
854830, 854832, 854834, 854836, 854838, 854840, 854842, 854844, 854846, 854848, 854850, 854852, 1593856, 1593858, 1871456, 1871459, 1871460, 1871461, 1871462, 1871463, 1871464, 1871465, 1871466, 1871467, 1871468, 1871469
SPL ID
81d087b6-4cb4-466a-9693-679edeb062e2
SPL set ID
704e4378-ca83-445c-8b45-3cfa51c1ecad
Package NDC
59417-101-10, 59417-102-10, 59417-103-10, 59417-104-10, 59417-105-10, 59417-106-10, 59417-107-10, 59417-115-01, 59417-116-01, 59417-117-01, 59417-118-01, 59417-119-01, 59417-120-01
UNII
SJT761GEGS
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.