Application 212038

Type: NDA
Sponsor: PURDUE PHARMA LP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ADHANSIA XR	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	25MG	Yes	No
002	ADHANSIA XR	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	35MG	Yes	No
003	ADHANSIA XR	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	45MG	Yes	No
004	ADHANSIA XR	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	55MG	Yes	No
005	ADHANSIA XR	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	70MG	Yes	No
006	ADHANSIA XR	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	85MG	Yes	No

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…`

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 4 of 4 · 74 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Lupin Pharmaceuticals,Inc.	57fd619e-687d-403c-a77a-3dc3a1bab65a	2023-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Lupin Pharmaceuticals,Inc.	5bfe50ed-171f-4c40-bc0b-20c68e8e2025	2023-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Eywa Pharma Inc	298fb86d-7d94-49e1-b743-3e7801122422	2023-11-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylin	METHYLPHENIDATE HYDROCHLORIDE	SHIONOGI INC.	9e3c22d9-71d9-46a7-b315-8021c94c4bec	2023-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	SpecGx LLC	981a2ad8-33f7-4678-9162-9df9685bd4a6	2023-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	XLCare Pharmaceuticals, Inc.	91833146-fa95-471a-8b8d-6d36a2db5c9a	2023-09-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Camber Pharmaceuticals Inc.	bb73cd3e-aa7c-4f7e-826d-75e71fb6d1e0	2023-09-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	QUAGEN PHARMACEUTICALS LLC	59de488c-c3f8-415d-9e9f-9102c090aac8	2023-02-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Ascend Laboratories, LLC	5fa3da25-13aa-4ee3-acf5-cd505f4688d0	2021-12-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Dr.Reddys Laboratories Inc	7124df7e-6273-a68d-6e35-dc06122d8686	2021-12-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	XLCare Pharmaceuticals Inc	94dc74d4-b4ef-45bc-b502-54ec692e9bd5	2021-08-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	b9af3104-172d-4975-9301-b9fe7db9ef12	2021-08-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	XLCare Pharmaceuticals, Inc.	b07150db-fd99-4400-bb83-b3a7544a917a	2021-08-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Ascent Pharmaceuticals, Inc.	45ebb59c-9603-4df6-b1be-3295ba2db1e7	2021-01-29	Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 48 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72912-525	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-525	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-525	ADHANSIA XR	methylphenidate hydrochloride Extented Release Capsules	Adlon Therapeutics L.P.	NDA	Current
72912-525	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-525	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-525	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-525	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-525	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-535	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-535	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-535	ADHANSIA XR	methylphenidate hydrochloride Extented Release Capsules	Adlon Therapeutics L.P.	NDA	Current
72912-535	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-535	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-535	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-535	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-535	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-545	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-545	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-545	ADHANSIA XR	methylphenidate hydrochloride Extented Release Capsules	Adlon Therapeutics L.P.	NDA	Current
72912-545	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-545	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-545	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-545	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-545	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-555	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-555	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-555	ADHANSIA XR	methylphenidate hydrochloride Extented Release Capsules	Adlon Therapeutics L.P.	NDA	Current
72912-555	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-555	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-555	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-555	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-555	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-570	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-570	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-570	ADHANSIA XR	methylphenidate hydrochloride Extented Release Capsules	Adlon Therapeutics L.P.	NDA	Current
72912-570	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-570	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-570	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-570	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-570	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-585	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-585	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-585	ADHANSIA XR	methylphenidate hydrochloride Extented Release Capsules	Adlon Therapeutics L.P.	NDA	Current
72912-585	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-585	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-585	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-585	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current
72912-585	ADHANSIA XR	methylphenidate hydrochloride	Adlon Therapeutics L.P.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67992	SUPPL	2021-06-30
67991	SUPPL	2021-06-30
69277	SUPPL	2021-06-29
67960	SUPPL	2021-06-29
67927	SUPPL	2021-06-28
67926	SUPPL	2021-06-28
59295	SUPPL	2019-07-10
59294	SUPPL	2019-07-10
59248	SUPPL	2019-07-05
59229	ORIG	2019-07-03
57828	ORIG	2019-02-28
57827	ORIG	2019-02-27
64328	ORIG	1900-01-01
64327	ORIG	1900-01-01
63147	ORIG	1900-01-01
63146	ORIG	1900-01-01
63145	ORIG	1900-01-01