ADHANSIA XR

Product NDC: 72912-525
Requested package NDC: 72912-525-30
11-digit product format: 729120525
Labeler code: 72912
Product ID: 72912-525_d5202e47-4f6c-423a-8f94-a8a5402da896
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methylphenidate hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Adlon Therapeutics L.P.
Application: NDA212038
Marketing category: NDA
Marketing start: 2019-07-01
Marketing end: 2023-11-01
Substance: METHYLPHENIDATE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	72912-525	72912-525-30	D	Discontinued by firm		2026-09-14

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 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N212038-001	ADHANSIA XR	METHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27
N212038-002	ADHANSIA XR	METHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27
N212038-003	ADHANSIA XR	METHYLPHENIDATE HYDROCHLORIDE	45MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27
N212038-004	ADHANSIA XR	METHYLPHENIDATE HYDROCHLORIDE	55MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27
N212038-005	ADHANSIA XR	METHYLPHENIDATE HYDROCHLORIDE	70MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27
N212038-006	ADHANSIA XR	METHYLPHENIDATE HYDROCHLORIDE	85MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27

Orange Book patents#

Current patent rows page 1 of 1 · 72 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212038-001	10111839	2035-10-30	U-2357		2019-03-08
N212038-001	10292938	2035-10-30		Drug product	2019-05-22
N212038-001	10292939	2035-10-30	U-2357	Drug product	2019-05-22
N212038-001	10449159	2035-10-30	U-2357		2019-10-22
N212038-001	10500162	2035-10-30	U-2357		2019-12-11
N212038-001	10507186	2035-10-30		Drug product	2019-12-18
N212038-001	10512612	2035-10-30		Drug product	2020-01-02
N212038-001	10512613	2035-10-30	U-2357		2020-01-02
N212038-001	10568841	2035-10-30	U-2357	Drug product	2020-02-26
N212038-001	10688060	2035-10-30		Drug product	2020-06-23
N212038-001	9974752	2035-10-30		Drug product	2019-03-08
N212038-001	10722473	2038-11-19	U-2357		2020-07-28
N212038-002	10111839	2035-10-30	U-2357		2019-03-08
N212038-002	10292938	2035-10-30		Drug product	2019-05-22
N212038-002	10292939	2035-10-30	U-2357	Drug product	2019-05-22
N212038-002	10449159	2035-10-30	U-2357		2019-10-22
N212038-002	10500162	2035-10-30	U-2357		2019-12-11
N212038-002	10507186	2035-10-30		Drug product	2019-12-18
N212038-002	10512612	2035-10-30		Drug product	2020-01-02
N212038-002	10512613	2035-10-30	U-2357		2020-01-02
N212038-002	10568841	2035-10-30	U-2357	Drug product	2020-02-26
N212038-002	10688060	2035-10-30		Drug product	2020-06-23
N212038-002	9974752	2035-10-30		Drug product	2019-03-08
N212038-002	10722473	2038-11-19	U-2357		2020-07-28
N212038-003	10111839	2035-10-30	U-2357		2019-03-08
N212038-003	10292938	2035-10-30		Drug product	2019-05-22
N212038-003	10292939	2035-10-30	U-2357	Drug product	2019-05-22
N212038-003	10449159	2035-10-30	U-2357		2019-10-22
N212038-003	10500162	2035-10-30	U-2357		2019-12-11
N212038-003	10507186	2035-10-30		Drug product	2019-12-18
N212038-003	10512612	2035-10-30		Drug product	2020-01-02
N212038-003	10512613	2035-10-30	U-2357		2020-01-02
N212038-003	10568841	2035-10-30	U-2357	Drug product	2020-02-26
N212038-003	10688060	2035-10-30		Drug product	2020-06-23
N212038-003	9974752	2035-10-30		Drug product	2019-03-08
N212038-003	10722473	2038-11-19	U-2357		2020-07-28
N212038-004	10111839	2035-10-30	U-2357		2019-03-08
N212038-004	10292938	2035-10-30		Drug product	2019-05-22
N212038-004	10292939	2035-10-30	U-2357	Drug product	2019-05-22
N212038-004	10449159	2035-10-30	U-2357		2019-10-22
N212038-004	10500162	2035-10-30	U-2357		2019-12-11
N212038-004	10507186	2035-10-30		Drug product	2019-12-18
N212038-004	10512612	2035-10-30		Drug product	2020-01-02
N212038-004	10512613	2035-10-30	U-2357		2020-01-02
N212038-004	10568841	2035-10-30	U-2357	Drug product	2020-02-26
N212038-004	10688060	2035-10-30		Drug product	2020-06-23
N212038-004	9974752	2035-10-30		Drug product	2019-03-08
N212038-004	10722473	2038-11-19	U-2357		2020-07-28
N212038-005	10111839	2035-10-30	U-2357		2019-03-08
N212038-005	10292938	2035-10-30		Drug product	2019-05-22
N212038-005	10292939	2035-10-30	U-2357	Drug product	2019-05-22
N212038-005	10449159	2035-10-30	U-2357		2019-10-22
N212038-005	10500162	2035-10-30	U-2357		2019-12-11
N212038-005	10507186	2035-10-30		Drug product	2019-12-18
N212038-005	10512612	2035-10-30		Drug product	2020-01-02
N212038-005	10512613	2035-10-30	U-2357		2020-01-02
N212038-005	10568841	2035-10-30	U-2357	Drug product	2020-02-26
N212038-005	10688060	2035-10-30		Drug product	2020-06-23
N212038-005	9974752	2035-10-30		Drug product	2019-03-08
N212038-005	10722473	2038-11-19	U-2357		2020-07-28
N212038-006	10111839	2035-10-30	U-2357		2019-03-08
N212038-006	10292938	2035-10-30		Drug product	2019-05-22
N212038-006	10292939	2035-10-30	U-2357	Drug product	2019-05-22
N212038-006	10449159	2035-10-30	U-2357		2019-10-22
N212038-006	10500162	2035-10-30	U-2357		2019-12-11
N212038-006	10507186	2035-10-30		Drug product	2019-12-18
N212038-006	10512612	2035-10-30		Drug product	2020-01-02
N212038-006	10512613	2035-10-30	U-2357		2020-01-02
N212038-006	10568841	2035-10-30	U-2357	Drug product	2020-02-26
N212038-006	10688060	2035-10-30		Drug product	2020-06-23
N212038-006	9974752	2035-10-30		Drug product	2019-03-08
N212038-006	10722473	2038-11-19	U-2357		2020-07-28

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 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N212038-001	ADHANSIA XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-002	ADHANSIA XR	35MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-003	ADHANSIA XR	45MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-004	ADHANSIA XR	55MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-005	ADHANSIA XR	70MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-006	ADHANSIA XR	85MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N212038-001	ADHANSIA XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212038-002	ADHANSIA XR	35MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212038-003	ADHANSIA XR	45MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212038-004	ADHANSIA XR	55MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212038-005	ADHANSIA XR	70MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212038-006	ADHANSIA XR	85MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212038-001	ADHANSIA XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212038-002	ADHANSIA XR	35MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212038-003	ADHANSIA XR	45MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212038-004	ADHANSIA XR	55MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212038-005	ADHANSIA XR	70MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212038-006	ADHANSIA XR	85MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212038-001	ADHANSIA XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212038-002	ADHANSIA XR	35MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212038-003	ADHANSIA XR	45MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212038-004	ADHANSIA XR	55MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212038-005	ADHANSIA XR	70MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212038-006	ADHANSIA XR	85MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212038-001	ADHANSIA XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212038-002	ADHANSIA XR	35MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212038-003	ADHANSIA XR	45MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212038-004	ADHANSIA XR	55MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212038-005	ADHANSIA XR	70MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212038-006	ADHANSIA XR	85MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212038-001	ADHANSIA XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212038-002	ADHANSIA XR	35MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212038-003	ADHANSIA XR	45MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212038-004	ADHANSIA XR	55MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212038-005	ADHANSIA XR	70MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212038-006	ADHANSIA XR	85MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212038-001	ADHANSIA XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212038-002	ADHANSIA XR	35MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212038-003	ADHANSIA XR	45MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212038-004	ADHANSIA XR	55MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-02-27	`b8a1b40f171c…`

Observed Orange Book patent history#

Patent history page 1 of 73 · 2,916 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N212038-001	10111839	2035-10-30	U-2357		2019-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-001	10292938	2035-10-30		Drug product	2019-05-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-001	10292939	2035-10-30	U-2357	Drug product	2019-05-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-001	10449159	2035-10-30	U-2357		2019-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-001	10500162	2035-10-30	U-2357		2019-12-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-001	10507186	2035-10-30		Drug product	2019-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-001	10512612	2035-10-30		Drug product	2020-01-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-001	10512613	2035-10-30	U-2357		2020-01-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-001	10568841	2035-10-30	U-2357	Drug product	2020-02-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-001	10688060	2035-10-30		Drug product	2020-06-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-001	9974752	2035-10-30		Drug product	2019-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-001	10722473	2038-11-19	U-2357		2020-07-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-002	10111839	2035-10-30	U-2357		2019-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-002	10292938	2035-10-30		Drug product	2019-05-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-002	10292939	2035-10-30	U-2357	Drug product	2019-05-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-002	10449159	2035-10-30	U-2357		2019-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-002	10500162	2035-10-30	U-2357		2019-12-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-002	10507186	2035-10-30		Drug product	2019-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-002	10512612	2035-10-30		Drug product	2020-01-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-002	10512613	2035-10-30	U-2357		2020-01-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-002	10568841	2035-10-30	U-2357	Drug product	2020-02-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-002	10688060	2035-10-30		Drug product	2020-06-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-002	9974752	2035-10-30		Drug product	2019-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-002	10722473	2038-11-19	U-2357		2020-07-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-003	10111839	2035-10-30	U-2357		2019-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-003	10292938	2035-10-30		Drug product	2019-05-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-003	10292939	2035-10-30	U-2357	Drug product	2019-05-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-003	10449159	2035-10-30	U-2357		2019-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-003	10500162	2035-10-30	U-2357		2019-12-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-003	10507186	2035-10-30		Drug product	2019-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-003	10512612	2035-10-30		Drug product	2020-01-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-003	10512613	2035-10-30	U-2357		2020-01-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-003	10568841	2035-10-30	U-2357	Drug product	2020-02-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-003	10688060	2035-10-30		Drug product	2020-06-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-003	9974752	2035-10-30		Drug product	2019-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-003	10722473	2038-11-19	U-2357		2020-07-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-004	10111839	2035-10-30	U-2357		2019-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-004	10292938	2035-10-30		Drug product	2019-05-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-004	10292939	2035-10-30	U-2357	Drug product	2019-05-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212038-004	10449159	2035-10-30	U-2357		2019-10-22	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 7 · 270 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212038-001	M-82	2024-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212038-002	M-82	2024-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212038-003	M-82	2024-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212038-004	M-82	2024-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212038-005	M-82	2024-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212038-006	M-82	2024-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212038-001	M-82	2024-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212038-002	M-82	2024-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212038-003	M-82	2024-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212038-004	M-82	2024-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212038-005	M-82	2024-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212038-006	M-82	2024-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212038-001	M-82	2024-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212038-002	M-82	2024-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212038-003	M-82	2024-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212038-004	M-82	2024-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212038-005	M-82	2024-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212038-006	M-82	2024-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212038-001	M-82	2024-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212038-002	M-82	2024-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212038-003	M-82	2024-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212038-004	M-82	2024-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212038-005	M-82	2024-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212038-006	M-82	2024-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212038-001	M-82	2024-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212038-002	M-82	2024-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212038-003	M-82	2024-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212038-004	M-82	2024-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212038-005	M-82	2024-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212038-006	M-82	2024-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212038-001	M-82	2024-06-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212038-002	M-82	2024-06-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212038-003	M-82	2024-06-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212038-004	M-82	2024-06-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212038-005	M-82	2024-06-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212038-006	M-82	2024-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212038-001	M-82	2024-06-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212038-002	M-82	2024-06-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212038-003	M-82	2024-06-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212038-004	M-82	2024-06-28	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72912-525-30	EA - Each	72912-525	c9f980cf-e30d-449d-ae1f-a7fbc69c7032	1	2019-07-02

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
72912-525-30	72912052530	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72912-525-30)	2019-07-01	2023-11-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ADHANSIA XR	Adlon Therapeutics L.P. \| Glatt Air Techniques \| Purdue Pharmaceuticals L.P. \| Janssen Pharmaceuticals, Inc. \| Noramco, Inc.	2023-04-19	HUMAN PRESCRIPTION DRUG LABEL	14