QuilliChew ER

Product NDC
24478-074
11-digit product format
244780074
Labeler code
24478
Product ID
24478-074_2d9338bb-0c67-4442-9179-f096efd3d0ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylphenidate hydrochloride
Dosage form
TABLET, CHEWABLE, EXTENDED RELEASE
Route
ORAL
Labeler
NextWave Pharmaceuticals, Inc
Application
NDA207960
Marketing category
NDA
Marketing start
2016-04-18
Substance
METHYLPHENIDATE HYDROCHLORIDE
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N207960-001QUILLICHEW ERMETHYLPHENIDATE HYDROCHLORIDE20MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD2015-12-04
N207960-002QUILLICHEW ERMETHYLPHENIDATE HYDROCHLORIDE30MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD2015-12-04
N207960-003QUILLICHEW ERMETHYLPHENIDATE HYDROCHLORIDE40MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD, RS2015-12-04

Orange Book patents#

Current patent rows page 1 of 1 · 30 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N207960-00182025372027-03-15Drug product2015-12-23
N207960-00182879032031-02-15Drug product2015-12-23
N207960-001108571432033-08-14U-2993Drug product2020-12-08
N207960-001111034942033-08-14Drug product2021-08-31
N207960-001111034952033-08-14U-2993Drug product2021-08-31
N207960-001116333892033-08-14Drug product2023-05-09
N207960-00189993862033-08-14Drug product2015-12-23
N207960-00192956422033-08-14U-1827Drug product2016-04-01
N207960-00195453992033-08-14U-1827Drug product2017-01-30
N207960-00198445442033-08-14U-2203Drug product2017-12-21
N207960-00282025372027-03-15Drug product2015-12-23
N207960-00282879032031-02-15Drug product2015-12-23
N207960-002108571432033-08-14U-2993Drug product2020-12-08
N207960-002111034942033-08-14Drug product2021-08-31
N207960-002111034952033-08-14U-2993Drug product2021-08-31
N207960-002116333892033-08-14Drug product2023-05-09
N207960-00289993862033-08-14Drug product2015-12-23
N207960-00292956422033-08-14U-1827Drug product2016-04-01
N207960-00295453992033-08-14U-1827Drug product2017-01-30
N207960-00298445442033-08-14U-2203Drug product2017-12-21
N207960-00382025372027-03-15Drug product2015-12-23
N207960-00382879032031-02-15Drug product2015-12-23
N207960-003108571432033-08-14U-2993Drug product2020-12-08
N207960-003111034942033-08-14Drug product2021-08-31
N207960-003111034952033-08-14U-2993Drug product2021-08-31
N207960-003116333892033-08-14Drug product2023-05-09
N207960-00389993862033-08-14Drug product2015-12-23
N207960-00392956422033-08-14U-1827Drug product2016-04-01
N207960-00395453992033-08-14U-1827Drug product2017-01-30
N207960-00398445442033-08-14U-2203Drug product2017-12-21

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N207960-001QUILLICHEW ER20MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD2015-12-0484e616aacf4f…
2026-09-14 22:38:342026-08N207960-002QUILLICHEW ER30MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD2015-12-0484e616aacf4f…
2026-09-14 22:38:342026-08N207960-003QUILLICHEW ER40MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD, RS2015-12-0484e616aacf4f…
2026-08-18 06:07:402026-07N207960-001QUILLICHEW ER20MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD2015-12-04caaa826d4ba7…
2026-08-18 06:07:402026-07N207960-002QUILLICHEW ER30MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD2015-12-04caaa826d4ba7…
2026-08-18 06:07:402026-07N207960-003QUILLICHEW ER40MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD, RS2015-12-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N207960-001QUILLICHEW ER20MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD2015-12-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207960-002QUILLICHEW ER30MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD2015-12-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207960-003QUILLICHEW ER40MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD, RS2015-12-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207960-001QUILLICHEW ER20MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD2015-12-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207960-002QUILLICHEW ER30MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD2015-12-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207960-003QUILLICHEW ER40MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD, RS2015-12-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08N207960-001QUILLICHEW ER20MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD2015-12-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207960-002QUILLICHEW ER30MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD2015-12-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207960-003QUILLICHEW ER40MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD, RS2015-12-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207960-001QUILLICHEW ER20MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD2015-12-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207960-002QUILLICHEW ER30MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD2015-12-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207960-003QUILLICHEW ER40MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD, RS2015-12-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207960-001QUILLICHEW ER20MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD2015-12-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207960-002QUILLICHEW ER30MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD2015-12-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207960-003QUILLICHEW ER40MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD, RS2015-12-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207960-001QUILLICHEW ER20MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD2015-12-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207960-002QUILLICHEW ER30MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD2015-12-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207960-003QUILLICHEW ER40MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD, RS2015-12-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207960-001QUILLICHEW ER20MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD2015-12-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207960-002QUILLICHEW ER30MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD2015-12-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207960-003QUILLICHEW ER40MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD, RS2015-12-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207960-001QUILLICHEW ER20MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD2015-12-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207960-002QUILLICHEW ER30MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD2015-12-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207960-003QUILLICHEW ER40MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD, RS2015-12-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207960-001QUILLICHEW ER20MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD2015-12-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207960-002QUILLICHEW ER30MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD2015-12-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207960-003QUILLICHEW ER40MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD, RS2015-12-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N207960-001QUILLICHEW ER20MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD2015-12-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N207960-002QUILLICHEW ER30MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD2015-12-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N207960-003QUILLICHEW ER40MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD, RS2015-12-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N207960-001QUILLICHEW ER20MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD2015-12-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N207960-002QUILLICHEW ER30MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD2015-12-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N207960-003QUILLICHEW ER40MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD, RS2015-12-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N207960-001QUILLICHEW ER20MGTABLET, EXTENDED RELEASE, CHEWABLE / ORALRLD2015-12-04301d65b070ca…

Observed Orange Book patent history#

Patent history page 1 of 30 · 1,167 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N207960-00182025372027-03-15Drug product2015-12-2384e616aacf4f…
2026-09-14 22:38:342026-08N207960-00182879032031-02-15Drug product2015-12-2384e616aacf4f…
2026-09-14 22:38:342026-08N207960-001108571432033-08-14U-2993Drug product2020-12-0884e616aacf4f…
2026-09-14 22:38:342026-08N207960-001111034942033-08-14Drug product2021-08-3184e616aacf4f…
2026-09-14 22:38:342026-08N207960-001111034952033-08-14U-2993Drug product2021-08-3184e616aacf4f…
2026-09-14 22:38:342026-08N207960-001116333892033-08-14Drug product2023-05-0984e616aacf4f…
2026-09-14 22:38:342026-08N207960-00189993862033-08-14Drug product2015-12-2384e616aacf4f…
2026-09-14 22:38:342026-08N207960-00192956422033-08-14U-1827Drug product2016-04-0184e616aacf4f…
2026-09-14 22:38:342026-08N207960-00195453992033-08-14U-1827Drug product2017-01-3084e616aacf4f…
2026-09-14 22:38:342026-08N207960-00198445442033-08-14U-2203Drug product2017-12-2184e616aacf4f…
2026-09-14 22:38:342026-08N207960-00282025372027-03-15Drug product2015-12-2384e616aacf4f…
2026-09-14 22:38:342026-08N207960-00282879032031-02-15Drug product2015-12-2384e616aacf4f…
2026-09-14 22:38:342026-08N207960-002108571432033-08-14U-2993Drug product2020-12-0884e616aacf4f…
2026-09-14 22:38:342026-08N207960-002111034942033-08-14Drug product2021-08-3184e616aacf4f…
2026-09-14 22:38:342026-08N207960-002111034952033-08-14U-2993Drug product2021-08-3184e616aacf4f…
2026-09-14 22:38:342026-08N207960-002116333892033-08-14Drug product2023-05-0984e616aacf4f…
2026-09-14 22:38:342026-08N207960-00289993862033-08-14Drug product2015-12-2384e616aacf4f…
2026-09-14 22:38:342026-08N207960-00292956422033-08-14U-1827Drug product2016-04-0184e616aacf4f…
2026-09-14 22:38:342026-08N207960-00295453992033-08-14U-1827Drug product2017-01-3084e616aacf4f…
2026-09-14 22:38:342026-08N207960-00298445442033-08-14U-2203Drug product2017-12-2184e616aacf4f…
2026-09-14 22:38:342026-08N207960-00382025372027-03-15Drug product2015-12-2384e616aacf4f…
2026-09-14 22:38:342026-08N207960-00382879032031-02-15Drug product2015-12-2384e616aacf4f…
2026-09-14 22:38:342026-08N207960-003108571432033-08-14U-2993Drug product2020-12-0884e616aacf4f…
2026-09-14 22:38:342026-08N207960-003111034942033-08-14Drug product2021-08-3184e616aacf4f…
2026-09-14 22:38:342026-08N207960-003111034952033-08-14U-2993Drug product2021-08-3184e616aacf4f…
2026-09-14 22:38:342026-08N207960-003116333892033-08-14Drug product2023-05-0984e616aacf4f…
2026-09-14 22:38:342026-08N207960-00389993862033-08-14Drug product2015-12-2384e616aacf4f…
2026-09-14 22:38:342026-08N207960-00392956422033-08-14U-1827Drug product2016-04-0184e616aacf4f…
2026-09-14 22:38:342026-08N207960-00395453992033-08-14U-1827Drug product2017-01-3084e616aacf4f…
2026-09-14 22:38:342026-08N207960-00398445442033-08-14U-2203Drug product2017-12-2184e616aacf4f…
2026-08-18 06:07:402026-07N207960-00182025372027-03-15Drug product2015-12-23caaa826d4ba7…
2026-08-18 06:07:402026-07N207960-00182879032031-02-15Drug product2015-12-23caaa826d4ba7…
2026-08-18 06:07:402026-07N207960-001108571432033-08-14U-2993Drug product2020-12-08caaa826d4ba7…
2026-08-18 06:07:402026-07N207960-001111034942033-08-14Drug product2021-08-31caaa826d4ba7…
2026-08-18 06:07:402026-07N207960-001111034952033-08-14U-2993Drug product2021-08-31caaa826d4ba7…
2026-08-18 06:07:402026-07N207960-001116333892033-08-14Drug product2023-05-09caaa826d4ba7…
2026-08-18 06:07:402026-07N207960-00189993862033-08-14Drug product2015-12-23caaa826d4ba7…
2026-08-18 06:07:402026-07N207960-00192956422033-08-14U-1827Drug product2016-04-01caaa826d4ba7…
2026-08-18 06:07:402026-07N207960-00195453992033-08-14U-1827Drug product2017-01-30caaa826d4ba7…
2026-08-18 06:07:402026-07N207960-00198445442033-08-14U-2203Drug product2017-12-21caaa826d4ba7…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE20 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
143536be-f21a-464c-bc5a-163f5c171815Product name220250626
fd4d0878-dcea-3832-288e-e3bbbbe580ffProduct name920240516
435f0341-cf24-41d5-8fbf-c909821e5596Product name120230313
c9b6eabb-08d7-bb2d-e81a-06be3590b436Product name220221216
67aa32c6-44f4-50de-64dd-643e8caf420dProduct name620210622
50b24f34-96fa-4f1e-b262-b0baf4a4a440Product name420210513
cf83c421-eebe-4de2-b1a2-fd96e3dbfcf8Product name120200128
166d1d2d-dd55-4fdf-82e2-b83a3c5347c1Product name120190828
343a61d5-785d-cc27-a43a-0779da054d88Product name320190828
7607489b-cd15-3103-f3b1-d4283574d250Product name220190614
407f0cce-da29-4050-a512-2cabe9e5692dProduct name920190611
f7f4bf1e-7c67-46c6-8c42-9beb1a06b38eProduct name220190415
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
190572d9-6c7b-4b40-8172-c1b5f802c20fProduct name120180724
2948856e-f76e-d380-d9ed-b317efafbc98Product name520180423
c0aa09de-7aa1-4a98-8f70-62ec3c97c695Product name120170803
3317aade-2d6e-f159-9fe6-e8385a825178Product name320160829
0fe52203-83a7-4fed-a91f-8e47a22cf1d3Product name120160111
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24478-074-01QuilliChew ER100 in 1 BOTTLETABLET, CHEWABLE, EXTENDED RELEA10029
24478-074-02QuilliChew ER30 in 1 BOTTLETABLET, CHEWABLE, EXTENDED RELEA3029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24478-074-01EA - Each24478-0743d6a7b5d-4353-4a2e-8c63-ebfc2b2ffd5e12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24478-074QUILLICHEW ER (METHYLPHENIDATE HYDROCHLORIDE) TABLET, CHEWABLE, EXTENDED RELEASE [NEXTWAVE PHARMACEUTICALS, INC]13Current NDC, Legacy NDC, 2 package rows20231108_defc1205-8e90-4b1e-b862-05e4c35c7364.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24478-074-0124478007401100 TABLET, CHEWABLE, EXTENDED RELEASE in 1 BOTTLE (24478-074-01) 2016-04-180000-00-00NoNoCurrent
24478-074-022447800740230 TABLET, CHEWABLE, EXTENDED RELEASE in 1 BOTTLE (24478-074-02) 2026-09-14NoNoCurrent