QuilliChew ER

Product NDC: 24478-074
11-digit product format: 244780074
Labeler code: 24478
Product ID: 24478-074_4aab4051-898f-4a8b-8450-cabadf465f24
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 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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHYLPHENIDATE HYDROCHLORIDE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4B3SC438HI	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1727443	Internal RxNorm lookup
1727450	Internal RxNorm lookup
1734928	Internal RxNorm lookup
1734930	Internal RxNorm lookup
1734951	Internal RxNorm lookup
1734953	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
defc1205-8e90-4b1e-b862-05e4c35c7364	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
143536be-f21a-464c-bc5a-163f5c171815	Product name	2	20250626
fd4d0878-dcea-3832-288e-e3bbbbe580ff	Product name	9	20240516
435f0341-cf24-41d5-8fbf-c909821e5596	Product name	1	20230313
c9b6eabb-08d7-bb2d-e81a-06be3590b436	Product name	2	20221216
67aa32c6-44f4-50de-64dd-643e8caf420d	Product name	6	20210622
50b24f34-96fa-4f1e-b262-b0baf4a4a440	Product name	4	20210513
cf83c421-eebe-4de2-b1a2-fd96e3dbfcf8	Product name	1	20200128
166d1d2d-dd55-4fdf-82e2-b83a3c5347c1	Product name	1	20190828
343a61d5-785d-cc27-a43a-0779da054d88	Product name	3	20190828
7607489b-cd15-3103-f3b1-d4283574d250	Product name	2	20190614
407f0cce-da29-4050-a512-2cabe9e5692d	Product name	9	20190611
f7f4bf1e-7c67-46c6-8c42-9beb1a06b38e	Product name	2	20190415
a90f088a-9578-47a2-8f6e-0a9d32aafec6	Product name	1	20181030
f6c90bdc-1674-455a-aadd-1b1b59e5edeb	Product name	2	20181030
190572d9-6c7b-4b40-8172-c1b5f802c20f	Product name	1	20180724
2948856e-f76e-d380-d9ed-b317efafbc98	Product name	5	20180423
c0aa09de-7aa1-4a98-8f70-62ec3c97c695	Product name	1	20170803
3317aade-2d6e-f159-9fe6-e8385a825178	Product name	3	20160829
0fe52203-83a7-4fed-a91f-8e47a22cf1d3	Product name	1	20160111
f1ec5c2f-d01e-a277-5826-c7eba86ed99b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
24478-074-01	QuilliChew ER	100 in 1 BOTTLE	TABLET, CHEWABLE, EXTENDED RELEA	100		29
24478-074-02	QuilliChew ER	30 in 1 BOTTLE	TABLET, CHEWABLE, EXTENDED RELEA	30		29

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24478-074-01	EA - Each	24478-074	3d6a7b5d-4353-4a2e-8c63-ebfc2b2ffd5e	1	2018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24478-074	QUILLICHEW ER (METHYLPHENIDATE HYDROCHLORIDE) TABLET, CHEWABLE, EXTENDED RELEASE [NEXTWAVE PHARMACEUTICALS, INC]	13	Current NDC, Legacy NDC, 2 package rows	20231108_defc1205-8e90-4b1e-b862-05e4c35c7364.zip

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 ndc (product): 24478-074

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
24478-074-01	24478007401	100 TABLET, CHEWABLE, EXTENDED RELEASE in 1 BOTTLE (24478-074-01)	2016-04-18	0000-00-00	No	No	Current
24478-074-02	24478007402	30 TABLET, CHEWABLE, EXTENDED RELEASE in 1 BOTTLE (24478-074-02)	2026-05-01		No	No	Current