Methylphenidate Extended-Release

Product NDC: 62542-100
11-digit product format: 625420100
Labeler code: 62542
Product ID: 62542-100_546188db-6a60-5a33-e063-6294a90ac39b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methylphenidate extended-release
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Neos Therapeutics, LP
Application: NDA205489
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2026-07-01
Substance: METHYLPHENIDATE
Active strength: 8.6 mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N205489-001	COTEMPLA XR-ODT	METHYLPHENIDATE	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2017-06-19
N205489-002	COTEMPLA XR-ODT	METHYLPHENIDATE	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2017-06-19
N205489-003	COTEMPLA XR-ODT	METHYLPHENIDATE	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD, RS	2017-06-19
N205489-004	COTEMPLA XR-ODT	METHYLPHENIDATE	34.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2024-08-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N205489-001	AB
N205489-002	AB
N205489-003	AB

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205489-001	8840924	2026-06-05		Drug product	2017-07-20
N205489-001	9072680	2032-06-28		Drug product	2017-07-20
N205489-001	9089496	2032-06-28		Drug product	2017-07-20
N205489-001	11166947	2038-01-25	U-3299		2022-02-10
N205489-002	8840924	2026-06-05		Drug product	2017-07-20
N205489-002	9072680	2032-06-28		Drug product	2017-07-20
N205489-002	9089496	2032-06-28		Drug product	2017-07-20
N205489-002	11166947	2038-01-25	U-3299		2022-02-10
N205489-003	8840924	2026-06-05		Drug product	2017-07-20
N205489-003	9072680	2032-06-28		Drug product	2017-07-20
N205489-003	9089496	2032-06-28		Drug product	2017-07-20
N205489-003	11166947	2038-01-25	U-3299		2022-02-10

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 4 · 142 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	N205489-001	COTEMPLA XR-ODT	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2017-06-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205489-002	COTEMPLA XR-ODT	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2017-06-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205489-003	COTEMPLA XR-ODT	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD, RS	2017-06-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205489-004	COTEMPLA XR-ODT	34.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2024-08-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205489-001	COTEMPLA XR-ODT	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2017-06-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205489-002	COTEMPLA XR-ODT	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2017-06-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205489-003	COTEMPLA XR-ODT	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD, RS	2017-06-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205489-004	COTEMPLA XR-ODT	34.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2024-08-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205489-001	COTEMPLA XR-ODT	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2017-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205489-002	COTEMPLA XR-ODT	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2017-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205489-003	COTEMPLA XR-ODT	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD, RS	2017-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205489-004	COTEMPLA XR-ODT	34.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2024-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205489-001	COTEMPLA XR-ODT	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2017-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205489-002	COTEMPLA XR-ODT	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2017-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205489-003	COTEMPLA XR-ODT	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD, RS	2017-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205489-004	COTEMPLA XR-ODT	34.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2024-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205489-001	COTEMPLA XR-ODT	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2017-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205489-002	COTEMPLA XR-ODT	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2017-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205489-003	COTEMPLA XR-ODT	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD, RS	2017-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205489-004	COTEMPLA XR-ODT	34.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2024-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205489-001	COTEMPLA XR-ODT	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2017-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205489-002	COTEMPLA XR-ODT	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2017-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205489-003	COTEMPLA XR-ODT	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD, RS	2017-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205489-004	COTEMPLA XR-ODT	34.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2024-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205489-001	COTEMPLA XR-ODT	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2017-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205489-002	COTEMPLA XR-ODT	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2017-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205489-003	COTEMPLA XR-ODT	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD, RS	2017-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205489-004	COTEMPLA XR-ODT	34.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2024-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205489-001	COTEMPLA XR-ODT	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2017-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205489-002	COTEMPLA XR-ODT	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2017-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205489-003	COTEMPLA XR-ODT	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD, RS	2017-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205489-004	COTEMPLA XR-ODT	34.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2024-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205489-001	COTEMPLA XR-ODT	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2017-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205489-002	COTEMPLA XR-ODT	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2017-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205489-003	COTEMPLA XR-ODT	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD, RS	2017-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205489-004	COTEMPLA XR-ODT	34.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2024-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205489-001	COTEMPLA XR-ODT	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2017-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205489-002	COTEMPLA XR-ODT	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2017-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205489-003	COTEMPLA XR-ODT	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD, RS	2017-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205489-004	COTEMPLA XR-ODT	34.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2024-08-19	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N205489-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205489-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205489-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205489-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205489-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205489-003	AB	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205489-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205489-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205489-003	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 486 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	N205489-001	8840924	2026-06-05		Drug product	2017-07-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205489-001	9072680	2032-06-28		Drug product	2017-07-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205489-001	9089496	2032-06-28		Drug product	2017-07-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205489-001	11166947	2038-01-25	U-3299		2022-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205489-002	8840924	2026-06-05		Drug product	2017-07-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205489-002	9072680	2032-06-28		Drug product	2017-07-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205489-002	9089496	2032-06-28		Drug product	2017-07-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205489-002	11166947	2038-01-25	U-3299		2022-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205489-003	8840924	2026-06-05		Drug product	2017-07-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205489-003	9072680	2032-06-28		Drug product	2017-07-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205489-003	9089496	2032-06-28		Drug product	2017-07-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205489-003	11166947	2038-01-25	U-3299		2022-02-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205489-001	8840924	2026-06-05		Drug product	2017-07-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205489-001	9072680	2032-06-28		Drug product	2017-07-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205489-001	9089496	2032-06-28		Drug product	2017-07-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205489-001	11166947	2038-01-25	U-3299		2022-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205489-002	8840924	2026-06-05		Drug product	2017-07-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205489-002	9072680	2032-06-28		Drug product	2017-07-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205489-002	9089496	2032-06-28		Drug product	2017-07-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205489-002	11166947	2038-01-25	U-3299		2022-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205489-003	8840924	2026-06-05		Drug product	2017-07-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205489-003	9072680	2032-06-28		Drug product	2017-07-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205489-003	9089496	2032-06-28		Drug product	2017-07-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205489-003	11166947	2038-01-25	U-3299		2022-02-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205489-001	8840924	2026-06-05		Drug product	2017-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205489-001	9072680	2032-06-28		Drug product	2017-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205489-001	9089496	2032-06-28		Drug product	2017-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205489-001	11166947	2038-01-25	U-3299		2022-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205489-002	8840924	2026-06-05		Drug product	2017-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205489-002	9072680	2032-06-28		Drug product	2017-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205489-002	9089496	2032-06-28		Drug product	2017-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205489-002	11166947	2038-01-25	U-3299		2022-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205489-003	8840924	2026-06-05		Drug product	2017-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205489-003	9072680	2032-06-28		Drug product	2017-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205489-003	9089496	2032-06-28		Drug product	2017-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205489-003	11166947	2038-01-25	U-3299		2022-02-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205489-001	8840924	2026-06-05		Drug product	2017-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205489-001	9072680	2032-06-28		Drug product	2017-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205489-001	9089496	2032-06-28		Drug product	2017-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205489-001	11166947	2038-01-25	U-3299		2022-02-10	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N205489-001	NP	2020-06-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205489-002	NP	2020-06-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205489-003	NP	2020-06-19	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N205489-001	NP	2020-06-19	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N205489-002	NP	2020-06-19	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N205489-003	NP	2020-06-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205489-001	NP	2020-06-19	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N205489-002	NP	2020-06-19	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N205489-003	NP	2020-06-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205489-001	NP	2020-06-19	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N205489-002	NP	2020-06-19	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N205489-003	NP	2020-06-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205489-001	NP	2020-06-19	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N205489-002	NP	2020-06-19	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N205489-003	NP	2020-06-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205489-001	NP	2020-06-19	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N205489-002	NP	2020-06-19	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N205489-003	NP	2020-06-19	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Methylphenidate Extended-Release
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHYLPHENIDATE	8.6 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
207ZZ9QZ49	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1926840	Internal RxNorm lookup
1926849	Internal RxNorm lookup
1926853	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c2fec19b-6610-4ce0-8e60-f8218a11f62f	Available on FDA.report

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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylphenidate Extended-Release	METHYLPHENIDATE EXTENDED-RELEASE	Neos Therapeutics, LP	c2fec19b-6610-4ce0-8e60-f8218a11f62f	2026-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 205489 application number: NDA205489 ndc (product): 62542-100
Cotempla XR-ODT	METHYLPHENIDATE	Neos Therapeutics Brands, LLC	33f70f58-c871-42c8-8adb-345caeafefcd	2025-09-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 205489 application number: NDA205489

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
207ZZ9QZ49	METHYLPHENIDATE	20748-11-2	METHYLPHENIDATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
62542-100-31	62542010031	30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62542-100-31)	2026-07-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methylphenidate Extended-Release	Neos Therapeutics, LP	2026-06-16	HUMAN PRESCRIPTION DRUG LABEL	2