Methylphenidate Transdermal System

Product NDC: 0574-2415
11-digit product format: 005742415
Labeler code: 0574
Product ID: 0574-2415_b743ef45-2fc0-4086-8a02-6078e6a09eaa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methylphenidate
Dosage form: PATCH
Route: TRANSDERMAL
Labeler: PADAGIS US LLC
Application: NDA021514
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2023-06-05
Substance: METHYLPHENIDATE
Active strength: 41.3 mg/mg
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N021514-001	DAYTRANA	METHYLPHENIDATE	10MG/9HR (1.1MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06
N021514-002	DAYTRANA	METHYLPHENIDATE	15MG/9HR (1.6MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06
N021514-003	DAYTRANA	METHYLPHENIDATE	20MG/9HR (2.2MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06
N021514-004	DAYTRANA	METHYLPHENIDATE	30MG/9HR (3.3MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2006-04-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N021514-001	AB
N021514-002	AB
N021514-003	AB
N021514-004	AB

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 5 · 168 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
2026-08-18 06:07:40	2026-07	N021514-001	DAYTRANA	10MG/9HR (1.1MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021514-002	DAYTRANA	15MG/9HR (1.6MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021514-003	DAYTRANA	20MG/9HR (2.2MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021514-004	DAYTRANA	30MG/9HR (3.3MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2006-04-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021514-001	DAYTRANA	10MG/9HR (1.1MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021514-002	DAYTRANA	15MG/9HR (1.6MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021514-003	DAYTRANA	20MG/9HR (2.2MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021514-004	DAYTRANA	30MG/9HR (3.3MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2006-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-001	DAYTRANA	10MG/9HR (1.1MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-002	DAYTRANA	15MG/9HR (1.6MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-003	DAYTRANA	20MG/9HR (2.2MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-004	DAYTRANA	30MG/9HR (3.3MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2006-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021514-001	DAYTRANA	10MG/9HR (1.1MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021514-002	DAYTRANA	15MG/9HR (1.6MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021514-003	DAYTRANA	20MG/9HR (2.2MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021514-004	DAYTRANA	30MG/9HR (3.3MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2006-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-001	DAYTRANA	10MG/9HR (1.1MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-002	DAYTRANA	15MG/9HR (1.6MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-003	DAYTRANA	20MG/9HR (2.2MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-004	DAYTRANA	30MG/9HR (3.3MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2006-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021514-001	DAYTRANA	10MG/9HR (1.1MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021514-002	DAYTRANA	15MG/9HR (1.6MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021514-003	DAYTRANA	20MG/9HR (2.2MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021514-004	DAYTRANA	30MG/9HR (3.3MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2006-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021514-001	DAYTRANA	10MG/9HR (1.1MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021514-002	DAYTRANA	15MG/9HR (1.6MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021514-003	DAYTRANA	20MG/9HR (2.2MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021514-004	DAYTRANA	30MG/9HR (3.3MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2006-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021514-001	DAYTRANA	10MG/9HR (1.1MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021514-002	DAYTRANA	15MG/9HR (1.6MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021514-003	DAYTRANA	20MG/9HR (2.2MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021514-004	DAYTRANA	30MG/9HR (3.3MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2006-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021514-001	DAYTRANA	10MG/9HR (1.1MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021514-002	DAYTRANA	15MG/9HR (1.6MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021514-003	DAYTRANA	20MG/9HR (2.2MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021514-004	DAYTRANA	30MG/9HR (3.3MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2006-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021514-001	DAYTRANA	10MG/9HR (1.1MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021514-002	DAYTRANA	15MG/9HR (1.6MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021514-003	DAYTRANA	20MG/9HR (2.2MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021514-004	DAYTRANA	30MG/9HR (3.3MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2006-04-06	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 124 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021514-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021514-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021514-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021514-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021514-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021514-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021514-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021514-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021514-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021514-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021514-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021514-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021514-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021514-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021514-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021514-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021514-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021514-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021514-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021514-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021514-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021514-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021514-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021514-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021514-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021514-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021514-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021514-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021514-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021514-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021514-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021514-004	AB	1	`d8e5a09893c0…`

Observed Orange Book patent history#

Patent history page 1 of 12 · 468 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-001	8632802	2025-10-07		Drug product	2014-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-001	9034370	2025-10-07		Drug product	2015-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-001	9668981	2025-10-07	U-2024		2017-07-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-002	8632802	2025-10-07		Drug product	2014-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-002	9034370	2025-10-07		Drug product	2015-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-002	9668981	2025-10-07	U-2024		2017-07-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-003	8632802	2025-10-07		Drug product	2014-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-003	9034370	2025-10-07		Drug product	2015-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-003	9668981	2025-10-07	U-2024		2017-07-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-004	8632802	2025-10-07		Drug product	2014-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-004	9034370	2025-10-07		Drug product	2015-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-004	9668981	2025-10-07	U-2024		2017-07-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021514-001	8632802	2025-10-07		Drug product	2014-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021514-001	9034370	2025-10-07		Drug product	2015-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021514-001	9668981	2025-10-07	U-2024		2017-07-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021514-002	8632802	2025-10-07		Drug product	2014-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021514-002	9034370	2025-10-07		Drug product	2015-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021514-002	9668981	2025-10-07	U-2024		2017-07-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021514-003	8632802	2025-10-07		Drug product	2014-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021514-003	9034370	2025-10-07		Drug product	2015-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021514-003	9668981	2025-10-07	U-2024		2017-07-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021514-004	8632802	2025-10-07		Drug product	2014-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021514-004	9034370	2025-10-07		Drug product	2015-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021514-004	9668981	2025-10-07	U-2024		2017-07-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-001	8632802	2025-10-07		Drug product	2014-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-001	9034370	2025-10-07		Drug product	2015-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-001	9668981	2025-10-07	U-2024		2017-07-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-002	8632802	2025-10-07		Drug product	2014-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-002	9034370	2025-10-07		Drug product	2015-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-002	9668981	2025-10-07	U-2024		2017-07-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-003	8632802	2025-10-07		Drug product	2014-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-003	9034370	2025-10-07		Drug product	2015-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-003	9668981	2025-10-07	U-2024		2017-07-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-004	8632802	2025-10-07		Drug product	2014-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-004	9034370	2025-10-07		Drug product	2015-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-004	9668981	2025-10-07	U-2024		2017-07-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021514-001	8632802	2025-10-07		Drug product	2014-02-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021514-001	9034370	2025-10-07		Drug product	2015-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021514-001	9668981	2025-10-07	U-2024		2017-07-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021514-002	8632802	2025-10-07		Drug product	2014-02-04	`b8a1b40f171c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Methylphenidate Transdermal System
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHYLPHENIDATE	41.3 mg/mg

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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
753436	Internal RxNorm lookup
753438	Internal RxNorm lookup
753440	Internal RxNorm lookup
753441	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
7bcff873-1fc2-45bc-a8e4-5db4edeb9bfb	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
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0574-2415-65	Methylphenidate Transdermal System	30 in 1 TRAY	PATCH	30		7
0574-2415-65	Methylphenidate Transdermal System	1 in 1 CARTON	PATCH	1		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0574-2415-65	EA - Each	0574-2415	fe5d98a3-f00f-4127-92f3-32af27971749	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0574-2415	METHYLPHENIDATE TRANSDERMAL SYSTEM (METHYLPHENIDATE) PATCH [PADAGIS US LLC]	5	Current NDC, 2 package rows	20241212_7bcff873-1fc2-45bc-a8e4-5db4edeb9bfb.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 Transdermal System	METHYLPHENIDATE	PADAGIS US LLC	7bcff873-1fc2-45bc-a8e4-5db4edeb9bfb	2025-09-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021514 application number: NDA021514 ndc (product): 0574-2415
Daytrana	METHYLPHENIDATE	Noven Therapeutics, LLC	2c312c31-3198-4775-91ab-294e0b4b9e7f	2025-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021514 application number: NDA021514

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
753436	methylphenidate 10 MG/9HR Transdermal System	PSN	7bcff873-1fc2-45bc-a8e4-5db4edeb9bfb	7
753438	methylphenidate 15 MG/9HR Transdermal System	PSN	7bcff873-1fc2-45bc-a8e4-5db4edeb9bfb	7
753440	methylphenidate 20 MG/9HR Transdermal System	PSN	7bcff873-1fc2-45bc-a8e4-5db4edeb9bfb	7
753441	methylphenidate 30 MG/9HR Transdermal System	PSN	7bcff873-1fc2-45bc-a8e4-5db4edeb9bfb	7
753436	9 HR methylphenidate 1.11 MG/HR Transdermal System	SCD	7bcff873-1fc2-45bc-a8e4-5db4edeb9bfb	7
753438	9 HR methylphenidate 1.67 MG/HR Transdermal System	SCD	7bcff873-1fc2-45bc-a8e4-5db4edeb9bfb	7
753440	9 HR methylphenidate 2.22 MG/HR Transdermal System	SCD	7bcff873-1fc2-45bc-a8e4-5db4edeb9bfb	7
753441	9 HR methylphenidate 3.33 MG/HR Transdermal System	SCD	7bcff873-1fc2-45bc-a8e4-5db4edeb9bfb	7
753436	methylphenidate 1.1 MG/HR 9HR Transdermal System	SY	7bcff873-1fc2-45bc-a8e4-5db4edeb9bfb	7
753436	methylphenidate 10 MG per 9HR Transdermal Patch	SY	7bcff873-1fc2-45bc-a8e4-5db4edeb9bfb	7
753436	methylphenidate 10 MG/9HR Transdermal System	SY	7bcff873-1fc2-45bc-a8e4-5db4edeb9bfb	7
753438	methylphenidate 15 MG per 9HR Transdermal Patch	SY	7bcff873-1fc2-45bc-a8e4-5db4edeb9bfb	7
753438	methylphenidate 15 MG/9HR Transdermal System	SY	7bcff873-1fc2-45bc-a8e4-5db4edeb9bfb	7
753440	methylphenidate 20 MG per 9HR Transdermal Patch	SY	7bcff873-1fc2-45bc-a8e4-5db4edeb9bfb	7
753440	methylphenidate 20 MG/9HR Transdermal System	SY	7bcff873-1fc2-45bc-a8e4-5db4edeb9bfb	7
753441	methylphenidate 30 MG per 9HR Transdermal Patch	SY	7bcff873-1fc2-45bc-a8e4-5db4edeb9bfb	7
753441	methylphenidate 30 MG/9HR Transdermal System	SY	7bcff873-1fc2-45bc-a8e4-5db4edeb9bfb	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0574-2415-65	00574241565	1 TRAY in 1 CARTON (0574-2415-65) / 30 POUCH in 1 TRAY / 1 PATCH in 1 POUCH / 41.3 mg in 1 PATCH	1 tray	2023-06-05	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
methylphenidate - PADAGIS US LLC \| NOVEN PHARMACEUTICALS, INC.	PADAGIS US LLC \| NOVEN PHARMACEUTICALS, INC.	2025-09-25	HUMAN PRESCRIPTION DRUG LABEL	7