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QuilliChew ER

methylphenidate hydrochloride · Tablet, Chewable, Extended Release

Prescription NDA Schedule CII 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
QuilliChew ER
Generic name
methylphenidate hydrochloride
Dosage form
Tablet, Chewable, Extended Release
Route
Oral
Marketing category
NDA · NDA
Labeler
NextWave Pharmaceuticals, Inc
Product type
Human Prescription Drug
DEA schedule
CII
Active ingredients
3
NDC product codes
3
Packages
6
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Methylphenidate Hydrochloride 20 mg/1 1091341 View
Methylphenidate Hydrochloride 30 mg/1 1091341 View
Methylphenidate Hydrochloride 40 mg/1 1091341 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Chewable, Extended Release
Route of administration
Oral
Presentations
9

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
207960
Application type
NDA · New Drug Application
Approval date
December 4, 2015
Sponsor
NEXTWAVE PHARMS
Products on application
3
Submissions recorded
7
Products approved under application 207960.
Product Trade name Form Strength Ingredient Status TE Flags
207960-001 QUILLICHEW ER TABLET, EXTENDED RELEASE, CHEWABLE METHYLPHENIDATE HYDROCHLORIDE Prescription — RLD
207960-002 QUILLICHEW ER TABLET, EXTENDED RELEASE, CHEWABLE METHYLPHENIDATE HYDROCHLORIDE Prescription — RLD
207960-003 QUILLICHEW ER TABLET, EXTENDED RELEASE, CHEWABLE METHYLPHENIDATE HYDROCHLORIDE Prescription — RLD RS

Therapeutic equivalence

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

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

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
8202537 March 15, 2027 001 No December 23, 2015
8202537 March 15, 2027 002 No December 23, 2015
8202537 March 15, 2027 003 No December 23, 2015
8287903 February 15, 2031 001 No December 23, 2015
8287903 February 15, 2031 002 No December 23, 2015
8287903 February 15, 2031 003 No December 23, 2015
9295642 August 14, 2033 001 No U-1827 April 1, 2016
11103495 August 14, 2033 001 No U-2993 August 31, 2021
9545399 August 14, 2033 001 No U-1827 January 30, 2017
9844544 August 14, 2033 001 No U-2203 December 21, 2017
10857143 August 14, 2033 001 No U-2993 December 8, 2020
11103494 August 14, 2033 001 No August 31, 2021
8999386 August 14, 2033 001 No December 23, 2015
11633389 August 14, 2033 001 No May 9, 2023
9545399 August 14, 2033 002 No U-1827 January 30, 2017
9844544 August 14, 2033 002 No U-2203 December 21, 2017
11103495 August 14, 2033 002 No U-2993 August 31, 2021
9295642 August 14, 2033 002 No U-1827 April 1, 2016
10857143 August 14, 2033 002 No U-2993 December 8, 2020
8999386 August 14, 2033 002 No December 23, 2015
11633389 August 14, 2033 002 No May 9, 2023
11103494 August 14, 2033 002 No August 31, 2021
9545399 August 14, 2033 003 No U-1827 January 30, 2017
9844544 August 14, 2033 003 No U-2203 December 21, 2017
10857143 August 14, 2033 003 No U-2993 December 8, 2020
11103495 August 14, 2033 003 No U-2993 August 31, 2021
9295642 August 14, 2033 003 No U-1827 April 1, 2016
11103494 August 14, 2033 003 No August 31, 2021
11633389 August 14, 2033 003 No May 9, 2023
8999386 August 14, 2033 003 No December 23, 2015

Approval history

Source: Drugs@FDA
Most recent submissions on application 207960.
Type No. Action Status Date Review
Supplement 21 Labeling Approved March 10, 2026 Standard
Supplement 18 Labeling Approved September 23, 2025 Standard
Supplement 16 Labeling Approved October 13, 2023 Standard
Supplement 12 Labeling Approved June 25, 2021 901 Required
Supplement 5 Labeling Approved February 28, 2017 Standard
Supplement 4 Labeling Approved January 4, 2017 901 Required
Original application 1 Type 3 - New Dosage Form Approved December 4, 2015 Standard

Review documents

  • 0 · Supplement · March 12, 2026
  • 0 · Supplement · March 12, 2026
  • 0 · Supplement · September 30, 2025
  • 0 · Supplement · September 25, 2025
  • 0 · Supplement · September 25, 2025
  • 0 · Supplement · October 23, 2023
  • 0 · Supplement · October 16, 2023
  • 0 · Supplement · June 29, 2021
  • 0 · Supplement · June 29, 2021
  • 0 · Supplement · March 8, 2017
  • 0 · Supplement · March 3, 2017
  • 0 · Supplement · January 17, 2017
  • 0 · Supplement · January 6, 2017
  • 0 · Original application · July 19, 2016
  • 0 · Original application · December 8, 2015
  • 0 · Original application · December 8, 2015
  • 0 · Original application · January 1, 1900
  • 0 · Original application · January 1, 1900
  • 0 · Original application · January 1, 1900
  • 0 · Original application · January 1, 1900

Adverse event reports

Source: openFDA FAERS
58,466
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: METHYLPHENIDATE HYDROCHLORIDE. 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
24478-074-01 24478-074 NextWave Pharmaceuticals, Inc 100 TABLET, CHEWABLE, EXTENDED RELEASE in 1 BOTTLE (24478-074-01) April 18, 2016
24478-074-02 24478-074 NextWave Pharmaceuticals, Inc 30 TABLET, CHEWABLE, EXTENDED RELEASE in 1 BOTTLE (24478-074-02) September 14, 2026
24478-075-01 24478-075 NextWave Pharmaceuticals, Inc 100 TABLET, CHEWABLE, EXTENDED RELEASE in 1 BOTTLE (24478-075-01) April 18, 2016
24478-075-02 24478-075 NextWave Pharmaceuticals, Inc 30 TABLET, CHEWABLE, EXTENDED RELEASE in 1 BOTTLE (24478-075-02) September 14, 2026
24478-076-01 24478-076 NextWave Pharmaceuticals, Inc 100 TABLET, CHEWABLE, EXTENDED RELEASE in 1 BOTTLE (24478-076-01) April 18, 2016
24478-076-02 24478-076 NextWave Pharmaceuticals, Inc 30 TABLET, CHEWABLE, EXTENDED RELEASE in 1 BOTTLE (24478-076-02) September 14, 2026
24478-074 24478-074 NextWave Pharmaceuticals, Inc — April 18, 2016
24478-075 24478-075 NextWave Pharmaceuticals, Inc — April 18, 2016
24478-076 24478-076 NextWave Pharmaceuticals, Inc — April 18, 2016

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.