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 5 of 8 · 301 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205831-007	AB3	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205831-001	AB3	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N205831-002	AB3	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N205831-003	AB3	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N205831-004	AB3	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N205831-005	AB3	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N205831-006	AB3	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N205831-007	AB3	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205831-001	AB3	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N205831-002	AB3	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N205831-003	AB3	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N205831-004	AB3	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N205831-005	AB3	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N205831-006	AB3	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N205831-007	AB3	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205831-001	AB3	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N205831-002	AB3	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N205831-003	AB3	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N205831-004	AB3	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N205831-005	AB3	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N205831-006	AB3	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N205831-007	AB3	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205831-001	AB3	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N205831-002	AB3	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N205831-003	AB3	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N205831-004	AB3	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N205831-005	AB3	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N205831-006	AB3	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N205831-007	AB3	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205831-001	AB3	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N205831-002	AB3	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N205831-003	AB3	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N205831-004	AB3	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N205831-005	AB3	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N205831-006	AB3	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N205831-007	AB3	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205831-001	AB3	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N205831-002	AB3	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N205831-003	AB3	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N205831-004	AB3	1	`ea99ee380514…`

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 1 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	Northstar Rx LLC	768bf181-d0d8-49e5-9c87-cacbb069e0b2	2026-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	45d33807-88b2-4b42-9c86-e5b05d7adec1	2026-08-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	18024571-4505-6d51-e063-6294a90a1972	2026-08-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Aurolife Pharma, LLC	35be77db-fbe3-487e-a220-a08a11aaec28	2026-08-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Golden State Medical Supply, Inc.	98be5c84-b348-6b8e-e053-2995a90ae4cc	2026-08-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride CD	METHYLPHENIDATE HYDROCHLORIDE	Lannett Company, LLC	e45c75dc-d381-475b-b649-a871c8a36e60	2026-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
METADATE CD	METHYLPHENIDATE HYDROCHLORIDE	Lannett Company, LLC	29f06562-6b6a-4ca6-b62e-d08a45fb3dd4	2026-07-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Lannett Company, Inc.	44737c1d-fe75-409e-8a58-591696d3d7aa	2026-05-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	10aa0dc0-bd0e-4927-a19a-8722d78ad67d	2026-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate	METHYLPHENIDATE HYDROCHLORIDE	KVK-Tech, Inc.	2cf1b26b-199d-4c7f-ab64-4805a9def2cc	2026-05-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Lannett Company, Inc.	3d1f5aff-5d39-496c-b5ed-7f3c70ec641c	2026-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Actavis Pharma, Inc.	85ef422d-af27-4126-9841-6892af1871d6	2026-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Trigen Laboratories, LLC	c45dc1de-adfa-4b3c-a7dc-cffbc8eac74f	2026-04-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Golden State Medical Supply, Inc.	22e5ddfa-7264-fbb1-e063-6394a90a6483	2026-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
CONCERTA	METHYLPHENIDATE HYDROCHLORIDE	Janssen Pharmaceuticals, Inc.	1a88218c-5b18-4220-8f56-526de1a276cd	2026-04-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Quillivant XR	METHYLPHENIDATE HYDROCHLORIDE	NextWave Pharmaceuticals, Inc	c2dc2109-44a6-4797-b04e-18761dd9d45a	2026-03-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	cd2c1226-fa19-4734-b62d-89fea73dcb0d	2026-03-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	5a29687b-5294-4b27-a556-514b092a877d	2026-03-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	KVK-TECH, INC.	1bf37f9f-29cf-4b09-9c81-eb369e35a042	2026-01-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	American Health Packaging	f6581305-cd1e-4171-8c1b-e184c7bde033	2025-12-04	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