Quillivant

Product NDC: 24478-323
Requested package NDC: 24478-323-05
11-digit product format: 244780323
Labeler code: 24478
Product ID: 24478-323_471e97b5-a75c-4901-be57-f77ad6a7856f
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
Substance: METHYLPHENIDATE HYDROCHLORIDE
Active strength: 750 mg/150mL
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	24478-323	24478-323-05	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 · 12 matching rows.

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

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

Additional Listing Data#

Finished product: Yes
Brand name base: Quillivant
Brand name suffix: XR
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHYLPHENIDATE HYDROCHLORIDE	750 mg/150mL

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1312583	Internal RxNorm lookup
1312589	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
c2dc2109-44a6-4797-b04e-18761dd9d45a	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
24478-323-05	QuillivantXR	150 mL in 1 BOTTLE	SUSPENSION, EXTENDED RELEASE	150		20
24478-323-05	QuillivantXR	1 in 1 CARTON	SUSPENSION, EXTENDED RELEASE	1		20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24478-323-05	ML - Milliliter	24478-323	e5bc14bb-9d5c-4f07-94ac-487c4fd888a0	1	2018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24478-323	QUILLIVANT XR (METHYLPHENIDATE HYDROCHLORIDE) SUSPENSION, EXTENDED RELEASE [NEXTWAVE PHARMACEUTICALS, INC]	11	Current NDC, Legacy NDC, 2 package rows	20231027_c2dc2109-44a6-4797-b04e-18761dd9d45a.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
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 ndc (package): 24478-323-05 ndc (product): 24478-323 ndc11 (package): 24478032305

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1312583	methylphenidate HCl 25 MG in 5 mL 24HR Extended Release Oral Suspension	PSN	c2dc2109-44a6-4797-b04e-18761dd9d45a	20
1312589	Quillivant XR 25 MG in 5 mL 24HR Extended Release Oral Suspension	PSN	c2dc2109-44a6-4797-b04e-18761dd9d45a	20
1312589	24 HR methylphenidate hydrochloride 5 MG/ML Extended Release Suspension [Quillivant]	SBD	c2dc2109-44a6-4797-b04e-18761dd9d45a	20
1312583	24 HR methylphenidate hydrochloride 5 MG/ML Extended Release Suspension	SCD	c2dc2109-44a6-4797-b04e-18761dd9d45a	20
1312589	24 HR Quillivant 5 MG/ML Extended Release Suspension	SY	c2dc2109-44a6-4797-b04e-18761dd9d45a	20
1312583	methylphenidate hydrochloride 25 MG per 5 ML 24 HR Extended Release Suspension	SY	c2dc2109-44a6-4797-b04e-18761dd9d45a	20
1312583	methylphenidate hydrochloride 5 MG/ML 24 HR Extended Release Suspension	SY	c2dc2109-44a6-4797-b04e-18761dd9d45a	20
1312589	Quillivant XR 25 MG per 5 ML 24 HR Extended Release Suspension	SY	c2dc2109-44a6-4797-b04e-18761dd9d45a	20
1312589	Quillivant XR 300 MG per 60 ML 24 HR Extended Release Suspension	SY	c2dc2109-44a6-4797-b04e-18761dd9d45a	20
1312589	Quillivant XR 600 MG per 120 ML 24 HR Extended Release Suspension	SY	c2dc2109-44a6-4797-b04e-18761dd9d45a	20
1312589	Quillivant XR 750 MG per 150 ML 24 HR Extended Release Suspension	SY	c2dc2109-44a6-4797-b04e-18761dd9d45a	20
1312589	Quillivant XR 900 MG per 180 ML 24 HR Extended Release Suspension	SY	c2dc2109-44a6-4797-b04e-18761dd9d45a	20

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
24478-323-05	24478032305	1 BOTTLE in 1 CARTON (24478-323-05) / 150 mL in 1 BOTTLE	1 bottle	2012-10-01	0000-00-00	No	No	Current