Cotempla XR-ODT

Product NDC: 70165-100
Requested package NDC: 70165-100-30
11-digit product format: 701650100
Labeler code: 70165
Product ID: 70165-100_3f8e1342-96a7-1d02-e063-6394a90a3903
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methylphenidate
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Neos Therapeutics Brands, LLC
Application: NDA205489
Marketing category: NDA
Marketing start: 2017-06-20
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: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	70165-100	70165-100-30	E	Excluded after deficient or non-compliant submission was not corrected		excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 134 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205489-001	COTEMPLA XR-ODT	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD	2017-06-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205489-002	COTEMPLA XR-ODT	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD	2017-06-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205489-003	COTEMPLA XR-ODT	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD, RS	2017-06-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205489-004	COTEMPLA XR-ODT	34.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD	2024-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205489-001	COTEMPLA XR-ODT	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD	2017-06-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205489-002	COTEMPLA XR-ODT	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD	2017-06-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205489-003	COTEMPLA XR-ODT	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD, RS	2017-06-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205489-004	COTEMPLA XR-ODT	34.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD	2024-08-19	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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 12 · 462 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
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…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205489-002	8840924	2026-06-05		Drug product	2017-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205489-002	9072680	2032-06-28		Drug product	2017-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205489-002	9089496	2032-06-28		Drug product	2017-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205489-002	11166947	2038-01-25	U-3299		2022-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205489-003	8840924	2026-06-05		Drug product	2017-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205489-003	9072680	2032-06-28		Drug product	2017-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205489-003	9089496	2032-06-28		Drug product	2017-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205489-003	11166947	2038-01-25	U-3299		2022-02-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205489-001	8840924	2026-06-05		Drug product	2017-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205489-001	9072680	2032-06-28		Drug product	2017-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205489-001	9089496	2032-06-28		Drug product	2017-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205489-001	11166947	2038-01-25	U-3299		2022-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205489-002	8840924	2026-06-05		Drug product	2017-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205489-002	9072680	2032-06-28		Drug product	2017-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205489-002	9089496	2032-06-28		Drug product	2017-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205489-002	11166947	2038-01-25	U-3299		2022-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205489-003	8840924	2026-06-05		Drug product	2017-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205489-003	9072680	2032-06-28		Drug product	2017-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205489-003	9089496	2032-06-28		Drug product	2017-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205489-003	11166947	2038-01-25	U-3299		2022-02-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205489-001	8840924	2026-06-05		Drug product	2017-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205489-001	9072680	2032-06-28		Drug product	2017-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205489-001	9089496	2032-06-28		Drug product	2017-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205489-001	11166947	2038-01-25	U-3299		2022-02-10	`fd3edfee7708…`

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Cotempla XR-ODT
Listing expiration: 2026-12-31

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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1926840	Internal RxNorm lookup
1926847	Internal RxNorm lookup
1926849	Internal RxNorm lookup
1926851	Internal RxNorm lookup
1926853	Internal RxNorm lookup
1926855	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
33f70f58-c871-42c8-8adb-345caeafefcd	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
143536be-f21a-464c-bc5a-163f5c171815	Product name	2	20250626
fd4d0878-dcea-3832-288e-e3bbbbe580ff	Product name	9	20240516
435f0341-cf24-41d5-8fbf-c909821e5596	Product name	1	20230313
c9b6eabb-08d7-bb2d-e81a-06be3590b436	Product name	2	20221216
67aa32c6-44f4-50de-64dd-643e8caf420d	Product name	6	20210622
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
50b24f34-96fa-4f1e-b262-b0baf4a4a440	Product name	4	20210513
cf83c421-eebe-4de2-b1a2-fd96e3dbfcf8	Product name	1	20200128
166d1d2d-dd55-4fdf-82e2-b83a3c5347c1	Product name	1	20190828
343a61d5-785d-cc27-a43a-0779da054d88	Product name	3	20190828
7607489b-cd15-3103-f3b1-d4283574d250	Product name	2	20190614
407f0cce-da29-4050-a512-2cabe9e5692d	Product name	9	20190611
f7f4bf1e-7c67-46c6-8c42-9beb1a06b38e	Product name	2	20190415
a90f088a-9578-47a2-8f6e-0a9d32aafec6	Product name	1	20181030
f6c90bdc-1674-455a-aadd-1b1b59e5edeb	Product name	2	20181030
190572d9-6c7b-4b40-8172-c1b5f802c20f	Product name	1	20180724
2948856e-f76e-d380-d9ed-b317efafbc98	Product name	5	20180423
c0aa09de-7aa1-4a98-8f70-62ec3c97c695	Product name	1	20170803
3317aade-2d6e-f159-9fe6-e8385a825178	Product name	3	20160829
0fe52203-83a7-4fed-a91f-8e47a22cf1d3	Product name	1	20160111
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
f1ec5c2f-d01e-a277-5826-c7eba86ed99b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70165-100-30	Cotempla XR-ODT	6 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	6		15
70165-100-30	Cotempla XR-ODT	5 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	5		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70165-100-30	EA - Each	70165-100	2e5466d2-eed8-4c19-97c1-d3a470f7b9c1	1	2017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70165-100	COTEMPLA XR-ODT (METHYLPHENIDATE) TABLET, ORALLY DISINTEGRATING [NEOS THERAPEUTICS BRANDS, LLC]	12	Current NDC, Legacy NDC, 2 package rows	20241109_33f70f58-c871-42c8-8adb-345caeafefcd.zip

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
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 ndc (package): 70165-100-30 ndc (product): 70165-100 ndc11 (package): 70165010030

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1926847	Cotempla XR-ODT 17.3 MG Extended Release Disintegrating Oral Tablet	PSN	33f70f58-c871-42c8-8adb-345caeafefcd	15
1926851	Cotempla XR-ODT 25.9 MG Extended Release Disintegrating Oral Tablet	PSN	33f70f58-c871-42c8-8adb-345caeafefcd	15
1926855	Cotempla XR-ODT 8.6 MG Extended Release Disintegrating Oral Tablet	PSN	33f70f58-c871-42c8-8adb-345caeafefcd	15
1926840	methylphenidate 17.3 MG Extended Release Disintegrating Oral Tablet	PSN	33f70f58-c871-42c8-8adb-345caeafefcd	15
1926849	methylphenidate 25.9 MG Extended Release Disintegrating Oral Tablet	PSN	33f70f58-c871-42c8-8adb-345caeafefcd	15
1926853	methylphenidate 8.6 MG Extended Release Disintegrating Oral Tablet	PSN	33f70f58-c871-42c8-8adb-345caeafefcd	15
1926847	methylphenidate 17.3 MG Disintegrating Oral Tablet [Cotempla]	SBD	33f70f58-c871-42c8-8adb-345caeafefcd	15
1926851	methylphenidate 25.9 MG Disintegrating Oral Tablet [Cotempla]	SBD	33f70f58-c871-42c8-8adb-345caeafefcd	15
1926855	methylphenidate 8.6 MG Disintegrating Oral Tablet [Cotempla]	SBD	33f70f58-c871-42c8-8adb-345caeafefcd	15
1926840	methylphenidate 17.3 MG Disintegrating Oral Tablet	SCD	33f70f58-c871-42c8-8adb-345caeafefcd	15
1926849	methylphenidate 25.9 MG Disintegrating Oral Tablet	SCD	33f70f58-c871-42c8-8adb-345caeafefcd	15
1926853	methylphenidate 8.6 MG Disintegrating Oral Tablet	SCD	33f70f58-c871-42c8-8adb-345caeafefcd	15
1926847	Cotempla 17.3 MG Disintegrating Oral Tablet	SY	33f70f58-c871-42c8-8adb-345caeafefcd	15
1926851	Cotempla 25.9 MG Disintegrating Oral Tablet	SY	33f70f58-c871-42c8-8adb-345caeafefcd	15
1926855	Cotempla 8.6 MG Disintegrating Oral Tablet	SY	33f70f58-c871-42c8-8adb-345caeafefcd	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70165-100-30	70165010030	5 BLISTER PACK in 1 CARTON (70165-100-30) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	5 blister pack	2017-06-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cotempla XR-ODT	Neos Therapeutics Brands, LLC \| Aphena Pharma Solutions \| Halo Pharmaceuticals, Inc.	2025-09-24	HUMAN PRESCRIPTION DRUG LABEL	15