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Vyvanse

Lisdexamfetamine Dimesylate · Tablet, Chewable

Prescription NDA Schedule CII TE AB RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Vyvanse
Generic name
Lisdexamfetamine Dimesylate
Dosage form
Tablet, Chewable
Route
Oral
Marketing category
NDA · NDA
Labeler
Takeda Pharmaceuticals America, Inc.
Product type
Human Prescription Drug
DEA schedule
CII
Active ingredients
6
NDC product codes
6
Packages
6
Data completeness
60% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Lisdexamfetamine Dimesylate 10 mg/1 854830 View
Lisdexamfetamine Dimesylate 20 mg/1 854830 View
Lisdexamfetamine Dimesylate 30 mg/1 854830 View
Lisdexamfetamine Dimesylate 40 mg/1 854830 View
Lisdexamfetamine Dimesylate 50 mg/1 854830 View
Lisdexamfetamine Dimesylate 60 mg/1 854830 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Chewable
Route of administration
Oral
Presentations
12

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Central Nervous System Stimulant [EPC] EPC All 93 members
Central Nervous System Stimulation [PE] PE All 95 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
208510
Application type
NDA · New Drug Application
Approval date
January 28, 2017
Sponsor
TAKEDA PHARMS USA
Products on application
6
Submissions recorded
9
Products approved under application 208510.
Product Trade name Form Strength Ingredient Status TE Flags
208510-001 VYVANSE TABLET, CHEWABLE LISDEXAMFETAMINE DIMESYLATE Prescription AB RLD
208510-002 VYVANSE TABLET, CHEWABLE LISDEXAMFETAMINE DIMESYLATE Prescription AB RLD
208510-003 VYVANSE TABLET, CHEWABLE LISDEXAMFETAMINE DIMESYLATE Prescription AB RLD
208510-004 VYVANSE TABLET, CHEWABLE LISDEXAMFETAMINE DIMESYLATE Prescription AB RLD
208510-005 VYVANSE TABLET, CHEWABLE LISDEXAMFETAMINE DIMESYLATE Prescription AB RLD
208510-006 VYVANSE TABLET, CHEWABLE LISDEXAMFETAMINE DIMESYLATE Prescription AB RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
Yes
Reference Standard
Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 208510.
Type No. Action Status Date Review
Supplement 9 Labeling Approved April 23, 2026 Standard
Supplement 11 Labeling Approved September 23, 2025 Standard
Supplement 7 Labeling Approved October 13, 2023 Standard
Supplement 5 Labeling Approved February 25, 2022 901 Required
Supplement 4 Labeling Approved November 2, 2021 Standard
Supplement 3 Efficacy Approved July 29, 2021 Priority
Supplement 2 Labeling Approved July 31, 2017 Standard
Supplement 1 Labeling Approved May 19, 2017 901 Required
Original application 1 Type 3 - New Dosage Form Approved January 28, 2017 Standard

Review documents

  • 0 · Supplement · April 27, 2026
  • 0 · Supplement · April 24, 2026
  • 0 · Supplement · April 24, 2026
  • 0 · Supplement · September 25, 2025
  • 0 · Supplement · September 25, 2025
  • 0 · Supplement · September 25, 2025
  • 0 · Supplement · October 16, 2023
  • 0 · Supplement · October 16, 2023
  • 0 · Supplement · March 1, 2022
  • 0 · Supplement · February 28, 2022
  • 0 · Supplement · November 3, 2021
  • 0 · Supplement · November 3, 2021
  • 0 · Supplement · August 2, 2021
  • 0 · Supplement · July 30, 2021
  • 0 · Original application · October 13, 2017
  • 0 · Supplement · August 2, 2017
  • 0 · Supplement · August 1, 2017
  • 0 · Supplement · May 23, 2017
  • 0 · Supplement · May 23, 2017
  • 0 · Original application · January 31, 2017
  • 0 · Original application · January 27, 2017
  • 0 · Original application · January 1, 1900
  • 0 · Original application · January 1, 1900

Adverse event reports

Source: openFDA FAERS
32,811
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: LISDEXAMFETAMINE DIMESYLATE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
59417-115-01 59417-115 Takeda Pharmaceuticals America, Inc. 100 TABLET, CHEWABLE in 1 BOTTLE (59417-115-01) January 28, 2017
59417-116-01 59417-116 Takeda Pharmaceuticals America, Inc. 100 TABLET, CHEWABLE in 1 BOTTLE (59417-116-01) January 28, 2017
59417-117-01 59417-117 Takeda Pharmaceuticals America, Inc. 100 TABLET, CHEWABLE in 1 BOTTLE (59417-117-01) January 28, 2017
59417-118-01 59417-118 Takeda Pharmaceuticals America, Inc. 100 TABLET, CHEWABLE in 1 BOTTLE (59417-118-01) January 28, 2017
59417-119-01 59417-119 Takeda Pharmaceuticals America, Inc. 100 TABLET, CHEWABLE in 1 BOTTLE (59417-119-01) January 28, 2017
59417-120-01 59417-120 Takeda Pharmaceuticals America, Inc. 100 TABLET, CHEWABLE in 1 BOTTLE (59417-120-01) January 28, 2017
59417-115 59417-115 Takeda Pharmaceuticals America, Inc. — January 28, 2017
59417-116 59417-116 Takeda Pharmaceuticals America, Inc. — January 28, 2017
59417-117 59417-117 Takeda Pharmaceuticals America, Inc. — January 28, 2017
59417-118 59417-118 Takeda Pharmaceuticals America, Inc. — January 28, 2017
59417-119 59417-119 Takeda Pharmaceuticals America, Inc. — January 28, 2017
59417-120 59417-120 Takeda Pharmaceuticals America, Inc. — January 28, 2017

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.