QuilliChew ER

Product NDC: 24478-130
11-digit product format: 244780130
Labeler code: 24478
Product ID: 24478-130_25328c32-7c32-4809-b38c-e8db1756e8a5
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
Marketing end: 0000-00-00
Substance: METHYLPHENIDATE HYDROCHLORIDE
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: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	24478-130		D	Discontinued by firm		2026-08-17
excluded package	package	24478-130	24478-130-01	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	24478-130-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	24478-130-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	24478-130-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	24478-130-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	24478-130-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	24478-130-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	24478-130-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	24478-130-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	24478-130-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	24478-130-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	24478-130-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	24478-130-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N207960-001	QUILLICHEW ER	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04
N207960-002	QUILLICHEW ER	METHYLPHENIDATE HYDROCHLORIDE	30MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04
N207960-003	QUILLICHEW ER	METHYLPHENIDATE HYDROCHLORIDE	40MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD, RS	2015-12-04

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N207960-001	8202537	2027-03-15		Drug product	2015-12-23
N207960-001	8287903	2031-02-15		Drug product	2015-12-23
N207960-001	10857143	2033-08-14	U-2993	Drug product	2020-12-08
N207960-001	11103494	2033-08-14		Drug product	2021-08-31
N207960-001	11103495	2033-08-14	U-2993	Drug product	2021-08-31
N207960-001	11633389	2033-08-14		Drug product	2023-05-09
N207960-001	8999386	2033-08-14		Drug product	2015-12-23
N207960-001	9295642	2033-08-14	U-1827	Drug product	2016-04-01
N207960-001	9545399	2033-08-14	U-1827	Drug product	2017-01-30
N207960-001	9844544	2033-08-14	U-2203	Drug product	2017-12-21
N207960-002	8202537	2027-03-15		Drug product	2015-12-23
N207960-002	8287903	2031-02-15		Drug product	2015-12-23
N207960-002	10857143	2033-08-14	U-2993	Drug product	2020-12-08
N207960-002	11103494	2033-08-14		Drug product	2021-08-31
N207960-002	11103495	2033-08-14	U-2993	Drug product	2021-08-31
N207960-002	11633389	2033-08-14		Drug product	2023-05-09
N207960-002	8999386	2033-08-14		Drug product	2015-12-23
N207960-002	9295642	2033-08-14	U-1827	Drug product	2016-04-01
N207960-002	9545399	2033-08-14	U-1827	Drug product	2017-01-30
N207960-002	9844544	2033-08-14	U-2203	Drug product	2017-12-21
N207960-003	8202537	2027-03-15		Drug product	2015-12-23
N207960-003	8287903	2031-02-15		Drug product	2015-12-23
N207960-003	10857143	2033-08-14	U-2993	Drug product	2020-12-08
N207960-003	11103494	2033-08-14		Drug product	2021-08-31
N207960-003	11103495	2033-08-14	U-2993	Drug product	2021-08-31
N207960-003	11633389	2033-08-14		Drug product	2023-05-09
N207960-003	8999386	2033-08-14		Drug product	2015-12-23
N207960-003	9295642	2033-08-14	U-1827	Drug product	2016-04-01
N207960-003	9545399	2033-08-14	U-1827	Drug product	2017-01-30
N207960-003	9844544	2033-08-14	U-2203	Drug product	2017-12-21

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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N207960-001	QUILLICHEW ER	20MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-002	QUILLICHEW ER	30MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-003	QUILLICHEW ER	40MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD, RS	2015-12-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N207960-001	QUILLICHEW ER	20MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207960-002	QUILLICHEW ER	30MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207960-003	QUILLICHEW ER	40MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD, RS	2015-12-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207960-001	QUILLICHEW ER	20MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207960-002	QUILLICHEW ER	30MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207960-003	QUILLICHEW ER	40MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD, RS	2015-12-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207960-001	QUILLICHEW ER	20MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207960-002	QUILLICHEW ER	30MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207960-003	QUILLICHEW ER	40MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD, RS	2015-12-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207960-001	QUILLICHEW ER	20MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207960-002	QUILLICHEW ER	30MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207960-003	QUILLICHEW ER	40MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD, RS	2015-12-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207960-001	QUILLICHEW ER	20MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207960-002	QUILLICHEW ER	30MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207960-003	QUILLICHEW ER	40MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD, RS	2015-12-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207960-001	QUILLICHEW ER	20MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207960-002	QUILLICHEW ER	30MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207960-003	QUILLICHEW ER	40MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD, RS	2015-12-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207960-001	QUILLICHEW ER	20MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207960-002	QUILLICHEW ER	30MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207960-003	QUILLICHEW ER	40MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD, RS	2015-12-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207960-001	QUILLICHEW ER	20MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207960-002	QUILLICHEW ER	30MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207960-003	QUILLICHEW ER	40MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD, RS	2015-12-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207960-001	QUILLICHEW ER	20MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207960-002	QUILLICHEW ER	30MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207960-003	QUILLICHEW ER	40MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD, RS	2015-12-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207960-001	QUILLICHEW ER	20MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207960-002	QUILLICHEW ER	30MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207960-003	QUILLICHEW ER	40MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD, RS	2015-12-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207960-001	QUILLICHEW ER	20MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207960-002	QUILLICHEW ER	30MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207960-003	QUILLICHEW ER	40MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD, RS	2015-12-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207960-001	QUILLICHEW ER	20MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207960-002	QUILLICHEW ER	30MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207960-003	QUILLICHEW ER	40MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD, RS	2015-12-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207960-001	QUILLICHEW ER	20MG	TABLET, EXTENDED RELEASE, CHEWABLE / ORAL	RLD	2015-12-04	`1e350fbaab3a…`

Observed Orange Book patent history#

Patent history page 1 of 29 · 1,137 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N207960-001	8202537	2027-03-15		Drug product	2015-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-001	8287903	2031-02-15		Drug product	2015-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-001	10857143	2033-08-14	U-2993	Drug product	2020-12-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-001	11103494	2033-08-14		Drug product	2021-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-001	11103495	2033-08-14	U-2993	Drug product	2021-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-001	11633389	2033-08-14		Drug product	2023-05-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-001	8999386	2033-08-14		Drug product	2015-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-001	9295642	2033-08-14	U-1827	Drug product	2016-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-001	9545399	2033-08-14	U-1827	Drug product	2017-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-001	9844544	2033-08-14	U-2203	Drug product	2017-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-002	8202537	2027-03-15		Drug product	2015-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-002	8287903	2031-02-15		Drug product	2015-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-002	10857143	2033-08-14	U-2993	Drug product	2020-12-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-002	11103494	2033-08-14		Drug product	2021-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-002	11103495	2033-08-14	U-2993	Drug product	2021-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-002	11633389	2033-08-14		Drug product	2023-05-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-002	8999386	2033-08-14		Drug product	2015-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-002	9295642	2033-08-14	U-1827	Drug product	2016-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-002	9545399	2033-08-14	U-1827	Drug product	2017-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-002	9844544	2033-08-14	U-2203	Drug product	2017-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-003	8202537	2027-03-15		Drug product	2015-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-003	8287903	2031-02-15		Drug product	2015-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-003	10857143	2033-08-14	U-2993	Drug product	2020-12-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-003	11103494	2033-08-14		Drug product	2021-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-003	11103495	2033-08-14	U-2993	Drug product	2021-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-003	11633389	2033-08-14		Drug product	2023-05-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-003	8999386	2033-08-14		Drug product	2015-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-003	9295642	2033-08-14	U-1827	Drug product	2016-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-003	9545399	2033-08-14	U-1827	Drug product	2017-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207960-003	9844544	2033-08-14	U-2203	Drug product	2017-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N207960-001	8202537	2027-03-15		Drug product	2015-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207960-001	8287903	2031-02-15		Drug product	2015-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207960-001	10857143	2033-08-14	U-2993	Drug product	2020-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207960-001	11103494	2033-08-14		Drug product	2021-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207960-001	11103495	2033-08-14	U-2993	Drug product	2021-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207960-001	11633389	2033-08-14		Drug product	2023-05-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207960-001	8999386	2033-08-14		Drug product	2015-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207960-001	9295642	2033-08-14	U-1827	Drug product	2016-04-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207960-001	9545399	2033-08-14	U-1827	Drug product	2017-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207960-001	9844544	2033-08-14	U-2203	Drug product	2017-12-21	`011fe1cb6892…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24478-130-01	EA - Each	24478-130	a6cc1ae1-6991-4ded-8ce8-f18c561b32b3	1	2016-02-04

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
QuilliChew ER	METHYLPHENIDATE HYDROCHLORIDE	NextWave Pharmaceuticals, Inc	defc1205-8e90-4b1e-b862-05e4c35c7364	2026-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 207960 application number: NDA207960

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4B3SC438HI	METHYLPHENIDATE HYDROCHLORIDE	23655-65-4	METHYLPHENIDATE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
24478-130-01	24478013001	100 TABLET, CHEWABLE, EXTENDED RELEASE in 1 BOTTLE (24478-130-01)	2016-04-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
QuilliChew ER	NextWave Pharmaceuticals, Inc. \| Tris Pharma, Inc.	2018-03-01	HUMAN PRESCRIPTION DRUG LABEL	9