Quillivant

Product NDC: 24478-190
11-digit product format: 244780190
Labeler code: 24478
Product ID: 24478-190_3c243fb6-41ad-44b8-a644-1d5a9d3df322
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methylphenidate hydrochloride
Dosage form: SUSPENSION, EXTENDED RELEASE
Route: ORAL
Labeler: NextWave Pharmaceuticals, Inc
Application: NDA202100
Marketing category: NDA
Marketing start: 2012-10-01
Marketing end: 0000-00-00
Substance: METHYLPHENIDATE HYDROCHLORIDE
Active strength: 300 mg/60mL
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	24478-190		D	Discontinued by firm		2026-08-10
excluded package	package	24478-190	24478-190-10	D	Discontinued by firm		2026-08-10

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	24478-190-10	`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	24478-190-10	`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	24478-190-10	`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	24478-190-10	`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	24478-190-10	`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	24478-190-10	`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	24478-190-10	`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	24478-190-10	`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	24478-190-10	`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	24478-190-10	`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	24478-190-10	`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	24478-190-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N202100-001	QUILLIVANT XR	METHYLPHENIDATE HYDROCHLORIDE	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-09-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N202100-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N202100-001	8062667	2029-03-29		Drug product	2012-10-22
N202100-001	8287903	2031-02-15		Drug product	2012-10-22
N202100-001	8465765	2031-02-15	U-1415	Drug product	2013-06-10
N202100-001	8563033	2031-02-15	U-1415	Drug product	2013-11-15
N202100-001	8778390	2031-02-15	U-1543	Drug product	2014-08-04
N202100-001	8956649	2031-02-15	U-1665	Drug product	2015-03-13
N202100-001	9040083	2031-02-15		Drug product	2015-06-09

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-09-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-09-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-09-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-09-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2012-09-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-09-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-09-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-09-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-09-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-09-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2012-09-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2012-09-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2012-09-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2012-09-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-09-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-09-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-09-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-09-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-09-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-09-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-09-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-09-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-09-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-09-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-09-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-09-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N202100-001	QUILLIVANT XR	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-09-27	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202100-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202100-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202100-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202100-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202100-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202100-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202100-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202100-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202100-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202100-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202100-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202100-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202100-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202100-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202100-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202100-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202100-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N202100-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202100-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202100-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202100-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202100-001	AB	1	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202100-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N202100-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N202100-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202100-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N202100-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N202100-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N202100-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N202100-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N202100-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N202100-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N202100-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N202100-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N202100-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202100-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 287 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202100-001	8062667	2029-03-29		Drug product	2012-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202100-001	8287903	2031-02-15		Drug product	2012-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202100-001	8465765	2031-02-15	U-1415	Drug product	2013-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202100-001	8563033	2031-02-15	U-1415	Drug product	2013-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202100-001	8778390	2031-02-15	U-1543	Drug product	2014-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202100-001	8956649	2031-02-15	U-1665	Drug product	2015-03-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202100-001	9040083	2031-02-15		Drug product	2015-06-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202100-001	8062667	2029-03-29		Drug product	2012-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202100-001	8287903	2031-02-15		Drug product	2012-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202100-001	8465765	2031-02-15	U-1415	Drug product	2013-06-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202100-001	8563033	2031-02-15	U-1415	Drug product	2013-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202100-001	8778390	2031-02-15	U-1543	Drug product	2014-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202100-001	8956649	2031-02-15	U-1665	Drug product	2015-03-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202100-001	9040083	2031-02-15		Drug product	2015-06-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202100-001	8062667	2029-03-29		Drug product	2012-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202100-001	8287903	2031-02-15		Drug product	2012-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202100-001	8465765	2031-02-15	U-1415	Drug product	2013-06-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202100-001	8563033	2031-02-15	U-1415	Drug product	2013-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202100-001	8778390	2031-02-15	U-1543	Drug product	2014-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202100-001	8956649	2031-02-15	U-1665	Drug product	2015-03-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202100-001	9040083	2031-02-15		Drug product	2015-06-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202100-001	8062667	2029-03-29		Drug product	2012-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202100-001	8287903	2031-02-15		Drug product	2012-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202100-001	8465765	2031-02-15	U-1415	Drug product	2013-06-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202100-001	8563033	2031-02-15	U-1415	Drug product	2013-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202100-001	8778390	2031-02-15	U-1543	Drug product	2014-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202100-001	8956649	2031-02-15	U-1665	Drug product	2015-03-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202100-001	9040083	2031-02-15		Drug product	2015-06-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202100-001	8062667	2029-03-29		Drug product	2012-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202100-001	8287903	2031-02-15		Drug product	2012-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202100-001	8465765	2031-02-15	U-1415	Drug product	2013-06-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202100-001	8563033	2031-02-15	U-1415	Drug product	2013-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202100-001	8778390	2031-02-15	U-1543	Drug product	2014-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202100-001	8956649	2031-02-15	U-1665	Drug product	2015-03-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202100-001	9040083	2031-02-15		Drug product	2015-06-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202100-001	8062667	2029-03-29		Drug product	2012-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202100-001	8287903	2031-02-15		Drug product	2012-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202100-001	8465765	2031-02-15	U-1415	Drug product	2013-06-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202100-001	8563033	2031-02-15	U-1415	Drug product	2013-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202100-001	8778390	2031-02-15	U-1543	Drug product	2014-08-04	`03ed91905a0d…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24478-190-10	ML - Milliliter	24478-190	2816e958-27ba-45c2-ae64-2492968d222c	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METHYLPHENIDATE HYDROCHLORIDE	ACTIVE INGREDIENT	4B3SC438HI	QUILLIVANT XR (METHYLPHENIDATE HYDROCHLORIDE) POWDER, FOR SUSPENSION [NEXTWAVE PHARMACEUTICALS, INC.]	13
METHYLPHENIDATE	ACTIVE MOIETY	207ZZ9QZ49	QUILLIVANT XR (METHYLPHENIDATE HYDROCHLORIDE) POWDER, FOR SUSPENSION [NEXTWAVE PHARMACEUTICALS, INC.]	13
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	QUILLIVANT XR (METHYLPHENIDATE HYDROCHLORIDE) POWDER, FOR SUSPENSION [NEXTWAVE PHARMACEUTICALS, INC.]	13
ANHYDROUS TRISODIUM CITRATE	INACTIVE INGREDIENT	RS7A450LGA	QUILLIVANT XR (METHYLPHENIDATE HYDROCHLORIDE) POWDER, FOR SUSPENSION [NEXTWAVE PHARMACEUTICALS, INC.]	13
POLOXAMER 188	INACTIVE INGREDIENT	LQA7B6G8JG	QUILLIVANT XR (METHYLPHENIDATE HYDROCHLORIDE) POWDER, FOR SUSPENSION [NEXTWAVE PHARMACEUTICALS, INC.]	13
POLYVINYL ACETATE PHTHALATE	INACTIVE INGREDIENT	58QVG85GW3	QUILLIVANT XR (METHYLPHENIDATE HYDROCHLORIDE) POWDER, FOR SUSPENSION [NEXTWAVE PHARMACEUTICALS, INC.]	13
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	QUILLIVANT XR (METHYLPHENIDATE HYDROCHLORIDE) POWDER, FOR SUSPENSION [NEXTWAVE PHARMACEUTICALS, INC.]	13
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	QUILLIVANT XR (METHYLPHENIDATE HYDROCHLORIDE) POWDER, FOR SUSPENSION [NEXTWAVE PHARMACEUTICALS, INC.]	13
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	QUILLIVANT XR (METHYLPHENIDATE HYDROCHLORIDE) POWDER, FOR SUSPENSION [NEXTWAVE PHARMACEUTICALS, INC.]	13
SODIUM POLYSTYRENE SULFONATE	INACTIVE INGREDIENT	1699G8679Z	QUILLIVANT XR (METHYLPHENIDATE HYDROCHLORIDE) POWDER, FOR SUSPENSION [NEXTWAVE PHARMACEUTICALS, INC.]	13
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	QUILLIVANT XR (METHYLPHENIDATE HYDROCHLORIDE) POWDER, FOR SUSPENSION [NEXTWAVE PHARMACEUTICALS, INC.]	13
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	QUILLIVANT XR (METHYLPHENIDATE HYDROCHLORIDE) POWDER, FOR SUSPENSION [NEXTWAVE PHARMACEUTICALS, INC.]	13
SUCROSE	INACTIVE INGREDIENT	C151H8M554	QUILLIVANT XR (METHYLPHENIDATE HYDROCHLORIDE) POWDER, FOR SUSPENSION [NEXTWAVE PHARMACEUTICALS, INC.]	13
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	QUILLIVANT XR (METHYLPHENIDATE HYDROCHLORIDE) POWDER, FOR SUSPENSION [NEXTWAVE PHARMACEUTICALS, INC.]	13
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	QUILLIVANT XR (METHYLPHENIDATE HYDROCHLORIDE) POWDER, FOR SUSPENSION [NEXTWAVE PHARMACEUTICALS, INC.]	13
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	QUILLIVANT XR (METHYLPHENIDATE HYDROCHLORIDE) POWDER, FOR SUSPENSION [NEXTWAVE PHARMACEUTICALS, INC.]	13

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
Quillivant XR	METHYLPHENIDATE HYDROCHLORIDE	NextWave Pharmaceuticals, Inc	c2dc2109-44a6-4797-b04e-18761dd9d45a	2026-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 202100 application number: NDA202100

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
24478-190-10	24478019010	1 BOTTLE in 1 CARTON (24478-190-10) > 60 mL in 1 BOTTLE	1 bottle	2012-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Quillivant XR	NextWave Pharmaceuticals, Inc \| Tris Pharma Inc	2017-10-17	HUMAN PRESCRIPTION DRUG LABEL	24