Application 205831

Type: NDA
Sponsor: RHODES PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	APTENSIO XR	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	10MG	Yes	No
002	APTENSIO XR	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	15MG	Yes	No
003	APTENSIO XR	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	20MG	Yes	No
004	APTENSIO XR	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	30MG	Yes	No
005	APTENSIO XR	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	40MG	Yes	No
006	APTENSIO XR	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	50MG	Yes	No
007	APTENSIO XR	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	60MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N205831-001	APTENSIO XR	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17
N205831-002	APTENSIO XR	METHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17
N205831-003	APTENSIO XR	METHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17
N205831-004	APTENSIO XR	METHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17
N205831-005	APTENSIO XR	METHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17
N205831-006	APTENSIO XR	METHYLPHENIDATE HYDROCHLORIDE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17
N205831-007	APTENSIO XR	METHYLPHENIDATE HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2015-04-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-product	TE code
N205831-001	AB3
N205831-002	AB3
N205831-003	AB3
N205831-004	AB3
N205831-005	AB3
N205831-006	AB3
N205831-007	AB3

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 8 · 301 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
2026-09-14 22:38:34	2026-08	N205831-001	APTENSIO XR	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205831-002	APTENSIO XR	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205831-003	APTENSIO XR	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205831-004	APTENSIO XR	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205831-005	APTENSIO XR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205831-006	APTENSIO XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205831-007	APTENSIO XR	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2015-04-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205831-001	APTENSIO XR	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205831-002	APTENSIO XR	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205831-003	APTENSIO XR	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205831-004	APTENSIO XR	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205831-005	APTENSIO XR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205831-006	APTENSIO XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205831-007	APTENSIO XR	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2015-04-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205831-001	APTENSIO XR	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205831-002	APTENSIO XR	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205831-003	APTENSIO XR	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205831-004	APTENSIO XR	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205831-005	APTENSIO XR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205831-006	APTENSIO XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205831-007	APTENSIO XR	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2015-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205831-001	APTENSIO XR	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205831-002	APTENSIO XR	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205831-003	APTENSIO XR	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205831-004	APTENSIO XR	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205831-005	APTENSIO XR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205831-006	APTENSIO XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205831-007	APTENSIO XR	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2015-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205831-001	APTENSIO XR	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205831-002	APTENSIO XR	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205831-003	APTENSIO XR	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205831-004	APTENSIO XR	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205831-005	APTENSIO XR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205831-006	APTENSIO XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205831-007	APTENSIO XR	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2015-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205831-001	APTENSIO XR	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205831-002	APTENSIO XR	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205831-003	APTENSIO XR	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205831-004	APTENSIO XR	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205831-005	APTENSIO XR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 301 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N205831-001	AB3	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205831-002	AB3	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205831-003	AB3	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205831-004	AB3	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205831-005	AB3	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205831-006	AB3	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205831-007	AB3	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205831-001	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205831-002	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205831-003	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205831-004	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205831-005	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205831-006	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205831-007	AB3	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205831-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205831-002	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205831-003	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205831-004	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205831-005	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205831-006	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205831-007	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205831-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205831-002	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205831-003	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205831-004	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205831-005	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205831-006	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205831-007	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205831-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205831-002	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205831-003	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205831-004	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205831-005	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205831-006	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205831-007	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205831-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205831-002	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205831-003	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205831-004	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205831-005	AB3	1	`fd3edfee7708…`

Observed Orange Book patent history#

Patent history page 1 of 15 · 567 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N205831-001	10039719	2019-12-16	U-2357		2018-08-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-001	6419960	2019-12-16		Drug product	2015-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-001	7083808	2019-12-16		Drug product	2015-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-001	7247318	2019-12-16		Drug product	2015-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-001	7438930	2019-12-16		Drug product, Delist requested	2015-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-001	8580310	2019-12-16		Drug product	2015-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-001	9066869	2019-12-16		Drug product	2015-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-001	9801823	2019-12-16		Drug product	2017-11-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-001	10039719*PED	2020-06-16		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-001	6419960*PED	2020-06-16		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-001	7083808*PED	2020-06-16		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-001	7247318*PED	2020-06-16		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-001	7438930*PED	2020-06-16		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-001	8580310*PED	2020-06-16		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-001	9066869*PED	2020-06-16		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-001	9801823*PED	2020-06-16		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-002	10039719	2019-12-16	U-2357		2018-08-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-002	6419960	2019-12-16		Drug product	2015-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-002	7083808	2019-12-16		Drug product	2015-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-002	7247318	2019-12-16		Drug product	2015-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-002	7438930	2019-12-16		Drug product, Delist requested	2015-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-002	8580310	2019-12-16		Drug product	2015-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-002	9066869	2019-12-16		Drug product	2015-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-002	9801823	2019-12-16		Drug product	2017-11-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-002	10039719*PED	2020-06-16		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-002	6419960*PED	2020-06-16		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-002	7083808*PED	2020-06-16		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-002	7247318*PED	2020-06-16		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-002	7438930*PED	2020-06-16		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-002	8580310*PED	2020-06-16		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-002	9066869*PED	2020-06-16		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-002	9801823*PED	2020-06-16		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-003	10039719	2019-12-16	U-2357		2018-08-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-003	6419960	2019-12-16		Drug product	2015-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-003	7083808	2019-12-16		Drug product	2015-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-003	7247318	2019-12-16		Drug product	2015-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-003	7438930	2019-12-16		Drug product, Delist requested	2015-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-003	8580310	2019-12-16		Drug product	2015-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-003	9066869	2019-12-16		Drug product	2015-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-003	9801823	2019-12-16		Drug product	2017-11-29	`74a2ff9319b5…`

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 2 of 4 · 72 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylphenidate Hydrochloride Extended-Release	METHYLPHENIDATE HYDROCHLORIDE	SpecGx LLC	9e11e093-4ff3-4bed-8fe9-3ee460b47303	2025-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
METADATE CD	METHYLPHENIDATE HYDROCHLORIDE	Aytu BioPharma, Inc.	be59f8b4-7842-42cc-9559-bfa747f0baa5	2025-11-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	9beb136f-020b-4631-b989-c1d26a9846f7	2025-11-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Actavis Pharma, Inc.	ecbb4a30-21ac-42e1-b4e9-6c35344ffc45	2025-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	American Health Packaging	eb9b7377-d918-43fb-8e82-d14c85ed64a8	2025-10-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	SpecGx LLC	ed004cf0-eb23-43d2-96dc-20c4ad63824f	2025-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
JORNAY PM Extended-Release	METHYLPHENIDATE HYDROCHLORIDE	Ironshore Pharmaceuticals Inc.	d95dede0-b1ff-4489-8f91-3bbe122852bf	2025-10-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride (LA)	METHYLPHENIDATE HYDROCHLORIDE	Dr. Reddy's Laboratories Inc	d8c14df4-ac05-d69d-9308-58a51d568329	2025-09-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
RELEXXII	METHYLPHENIDATE HYDROCHLORIDE	Vertical Pharmaceuticals, LLC	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	2025-09-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Trigen Laboratories, LLC	dd8d7b6e-c23d-4e16-bb53-959e9127ebc6	2025-09-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Ritalin LA	METHYLPHENIDATE HYDROCHLORIDE	Novartis Pharmaceuticals Corporation	effd952d-ac94-47bb-b107-589a4934dcca	2025-09-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Solco Healthcare US,LLC	238ff743-4f25-43a3-87ac-6559d12a9d49	2025-09-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Camber Pharmaceutical Inc	778190da-1528-4def-94bf-ee23ee5268a5	2025-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	5a22dd9b-9b48-4c96-8b20-0d20131521dc	2025-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	1c7d7e6c-4e96-4d18-8dca-203ef50766ec	2025-03-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	e5cb0740-813f-4dce-8c29-d7680c66e77c	2025-03-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	1a89b390-0cd5-45cb-9e70-20de44652c56	2025-02-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	c614cf55-b462-4f7e-b19c-6d22a47e509f	2025-02-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Ritalin	METHYLPHENIDATE HYDROCHLORIDE	Sandoz Inc	d6fb2750-cdab-4749-ba0d-7534840a5892	2025-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Cranbury Pharmaceuticals, LLC	e817377f-bc72-415a-acd2-7136746b2479	2025-01-30	Boxed warning, 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 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42858-075	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Rhodes Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
42858-075	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Rhodes Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
42858-076	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Rhodes Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
42858-076	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Rhodes Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
42858-077	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Rhodes Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
42858-077	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Rhodes Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
42858-078	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Rhodes Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
42858-078	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Rhodes Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
42858-079	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Rhodes Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
42858-079	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Rhodes Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
42858-080	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Rhodes Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
42858-080	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Rhodes Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
42858-081	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Rhodes Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
42858-081	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Rhodes Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
42858-401	APTENSIO XR	(methylphenidate hydrochloride)	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-401	APTENSIO XR	(methylphenidate hydrochloride)	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-401	APTENSIO XR	(methylphenidate hydrochloride)	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-402	APTENSIO XR	(methylphenidate hydrochloride)	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-402	APTENSIO XR	(methylphenidate hydrochloride)	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-402	APTENSIO XR	(methylphenidate hydrochloride)	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-403	APTENSIO XR	(methylphenidate hydrochloride)	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-403	APTENSIO XR	(methylphenidate hydrochloride)	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-403	APTENSIO XR	(methylphenidate hydrochloride)	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-404	APTENSIO XR	(methylphenidate hydrochloride)	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-404	APTENSIO XR	(methylphenidate hydrochloride)	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-404	APTENSIO XR	(methylphenidate hydrochloride)	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-405	APTENSIO XR	(methylphenidate hydrochloride)	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-405	APTENSIO XR	(methylphenidate hydrochloride)	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-405	APTENSIO XR	(methylphenidate hydrochloride)	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-406	APTENSIO XR	(methylphenidate hydrochloride)	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-406	APTENSIO XR	(methylphenidate hydrochloride)	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-406	APTENSIO XR	(methylphenidate hydrochloride)	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-407	APTENSIO XR	(methylphenidate hydrochloride)	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-407	APTENSIO XR	(methylphenidate hydrochloride)	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-407	APTENSIO XR	(methylphenidate hydrochloride)	Rhodes Pharmaceuticals L.P.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83492	SUPPL	2025-09-25
83491	SUPPL	2025-09-25
83450	SUPPL	2025-09-25
75799	SUPPL	2023-10-17
75764	SUPPL	2023-10-16
67945	SUPPL	2021-06-29
67943	SUPPL	2021-06-29
67937	SUPPL	2021-06-29
59114	SUPPL	2019-06-18
59098	SUPPL	2019-06-17
59097	SUPPL	2019-06-17
46751	SUPPL	2017-01-10
46701	SUPPL	2017-01-06
24506	ORIG	2015-06-05
23004	ORIG	2015-06-05
19686	ORIG	2015-05-12
32739	ORIG	2015-04-27
63993	ORIG	1900-01-01
63992	ORIG	1900-01-01
63227	ORIG	1900-01-01
51359	ORIG	1900-01-01
51358	ORIG	1900-01-01
51357	ORIG	1900-01-01
51356	ORIG	1900-01-01