APTENSIO XR

Product NDC: 42858-404
11-digit product format: 428580404
Labeler code: 42858
Product ID: 42858-404_9468380f-2590-4c7a-9451-81776fa2cfaf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: (methylphenidate hydrochloride)
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Rhodes Pharmaceuticals L.P.
Application: NDA205831
Marketing category: NDA
Marketing start: 2015-04-17
Marketing end: 0000-00-00
Substance: METHYLPHENIDATE HYDROCHLORIDE
Active strength: 30 mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42858-404		D	Discontinued by firm		2026-10-15
excluded package	package	42858-404	42858-404-45	D	Discontinued by firm		2026-10-15

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 308 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
2026-10-15 13:18:30	2026-09	N205831-001	APTENSIO XR	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205831-002	APTENSIO XR	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205831-003	APTENSIO XR	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205831-004	APTENSIO XR	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205831-005	APTENSIO XR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205831-006	APTENSIO XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205831-007	APTENSIO XR	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2015-04-17	`c2088c7a36db…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 8 · 308 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205831-006	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205831-007	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205831-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205831-002	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205831-003	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205831-004	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205831-005	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205831-006	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205831-007	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205831-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205831-002	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205831-003	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205831-004	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205831-005	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205831-006	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205831-007	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205831-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205831-002	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205831-003	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205831-004	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205831-005	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205831-006	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205831-007	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205831-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205831-002	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205831-003	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205831-004	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205831-005	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205831-006	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205831-007	AB3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205831-001	AB3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205831-002	AB3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205831-003	AB3	1	`d8e5a09893c0…`

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…`

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
42858-404-45	EA - Each	42858-404	cab01747-7e67-42ab-81d6-f1f05ce1423b	1	2015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METHYLPHENIDATE HYDROCHLORIDE	ACTIVE INGREDIENT	4B3SC438HI	APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.]	5
METHYLPHENIDATE	ACTIVE MOIETY	207ZZ9QZ49	APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.]	5
AMMONIO METHACRYLATE COPOLYMER TYPE B	INACTIVE INGREDIENT	161H3B14U2	APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.]	5
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.]	5
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.]	5
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.]	5
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.]	5
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.]	5
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.]	5
GELATIN	INACTIVE INGREDIENT	2G86QN327L	APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.]	5
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.]	5
SUCROSE	INACTIVE INGREDIENT	C151H8M554	APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.]	5
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42858-404	APTENSIO XR (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.]	13	Legacy NDC	20240410_5adedc01-ebf0-11e3-ac10-0800200c9a66.zip

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
42858-404-45	42858040445	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-404-45)	2015-04-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
APTENSIO XR	Rhodes Pharmaceuticals L.P. \| Patheon Manufacturing Services LLC \| Purdue Pharmaceuticals L.P.	2025-09-25	HUMAN PRESCRIPTION DRUG LABEL	16