Dexmethylphenidate Hydrochloride

Product NDC: 69189-2685
11-digit product format: 691892685
Labeler code: 69189
Product ID: 69189-2685_a84b2038-f235-44be-9e1e-8665973ac05a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dexmethylphenidate hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Avera McKennan Hospital
Application: NDA021802
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2015-12-01
Marketing end: 0000-00-00
Substance: DEXMETHYLPHENIDATE HYDROCHLORIDE
Active strength: 20 mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA schedule: CII
NDC exclude flag: E
Listing certified through: 2017-12-31
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	69189-2685		I	Inactivated by FDA		2026-08-17
excluded package	package	69189-2685	69189-2685-1	I	Inactivated by FDA		2026-08-17

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69189-2685-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69189-2685-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69189-2685-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69189-2685-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69189-2685-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69189-2685-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69189-2685-1	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69189-2685-1	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69189-2685-1	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69189-2685-1	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69189-2685-1	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69189-2685-1	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69189-2685-1	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69189-2685-1	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69189-2685-1	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69189-2685-1	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69189-2685-1	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69189-2685-1	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	69189-2685-1	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	69189-2685-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	69189-2685-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	69189-2685-1	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021802-001	FOCALIN XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26
N021802-002	FOCALIN XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26
N021802-003	FOCALIN XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26
N021802-004	FOCALIN XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-08-01
N021802-005	FOCALIN XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2009-10-23
N021802-006	FOCALIN XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2010-08-11
N021802-007	FOCALIN XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2011-04-21
N021802-008	FOCALIN XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2011-04-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-product	TE code
N021802-001	AB
N021802-002	AB
N021802-003	AB
N021802-004	AB
N021802-005	AB
N021802-006	AB
N021802-007	AB
N021802-008	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 9 · 336 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	N021802-001	FOCALIN XR	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021802-002	FOCALIN XR	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021802-003	FOCALIN XR	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021802-004	FOCALIN XR	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-08-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021802-005	FOCALIN XR	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2009-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021802-006	FOCALIN XR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2010-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021802-007	FOCALIN XR	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2011-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021802-008	FOCALIN XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2011-04-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021802-001	FOCALIN XR	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021802-002	FOCALIN XR	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021802-003	FOCALIN XR	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021802-004	FOCALIN XR	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021802-005	FOCALIN XR	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2009-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021802-006	FOCALIN XR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2010-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021802-007	FOCALIN XR	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2011-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021802-008	FOCALIN XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2011-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021802-001	FOCALIN XR	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021802-002	FOCALIN XR	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021802-003	FOCALIN XR	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021802-004	FOCALIN XR	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021802-005	FOCALIN XR	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2009-10-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021802-006	FOCALIN XR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2010-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021802-007	FOCALIN XR	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2011-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021802-008	FOCALIN XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2011-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021802-001	FOCALIN XR	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021802-002	FOCALIN XR	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021802-003	FOCALIN XR	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021802-004	FOCALIN XR	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-08-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021802-005	FOCALIN XR	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2009-10-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021802-006	FOCALIN XR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2010-08-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021802-007	FOCALIN XR	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2011-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021802-008	FOCALIN XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2011-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021802-001	FOCALIN XR	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021802-002	FOCALIN XR	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021802-003	FOCALIN XR	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021802-004	FOCALIN XR	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-08-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021802-005	FOCALIN XR	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2009-10-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021802-006	FOCALIN XR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2010-08-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021802-007	FOCALIN XR	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2011-04-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021802-008	FOCALIN XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2011-04-21	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 336 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	N021802-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021802-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021802-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021802-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021802-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021802-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021802-007	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021802-008	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021802-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021802-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021802-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021802-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021802-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021802-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021802-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021802-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021802-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021802-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021802-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021802-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021802-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021802-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021802-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021802-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021802-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021802-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021802-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021802-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021802-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021802-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021802-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021802-008	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021802-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021802-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021802-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021802-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021802-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021802-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021802-007	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021802-008	AB	1	`fd3edfee7708…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 64 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	N021802-001	6228398	2019-11-01	U-676	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021802-001	6730325	2019-11-01	U-676	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021802-002	6228398	2019-11-01	U-676	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021802-002	6730325	2019-11-01	U-676	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021802-003	6228398	2019-11-01	U-676	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021802-003	6730325	2019-11-01	U-676	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021802-004	6228398	2019-11-01	U-676	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021802-004	6730325	2019-11-01	U-676	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021802-005	6228398	2019-11-01	U-676	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021802-005	6730325	2019-11-01	U-676	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021802-006	6228398	2019-11-01	U-676	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021802-006	6730325	2019-11-01	U-676	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021802-007	6228398	2019-11-01	U-676	Drug product	2011-05-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021802-007	6730325	2019-11-01	U-676	Drug product	2011-05-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021802-008	6228398	2019-11-01	U-676	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021802-008	6730325	2019-11-01	U-676	Drug product		`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021802-001	6228398	2019-11-01	U-676	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021802-001	6730325	2019-11-01	U-676	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021802-002	6228398	2019-11-01	U-676	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021802-002	6730325	2019-11-01	U-676	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021802-003	6228398	2019-11-01	U-676	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021802-003	6730325	2019-11-01	U-676	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021802-004	6228398	2019-11-01	U-676	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021802-004	6730325	2019-11-01	U-676	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021802-005	6228398	2019-11-01	U-676	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021802-005	6730325	2019-11-01	U-676	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021802-006	6228398	2019-11-01	U-676	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021802-006	6730325	2019-11-01	U-676	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021802-007	6228398	2019-11-01	U-676	Drug product	2011-05-24	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021802-007	6730325	2019-11-01	U-676	Drug product	2011-05-24	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021802-008	6228398	2019-11-01	U-676	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021802-008	6730325	2019-11-01	U-676	Drug product		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021802-001	6228398	2019-11-01	U-676	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021802-001	6730325	2019-11-01	U-676	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021802-002	6228398	2019-11-01	U-676	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021802-002	6730325	2019-11-01	U-676	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021802-003	6228398	2019-11-01	U-676	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021802-003	6730325	2019-11-01	U-676	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021802-004	6228398	2019-11-01	U-676	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021802-004	6730325	2019-11-01	U-676	Drug product		`b00525d2431f…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1ff349b0-f325-4585-9c0d-7dc58eb1bc1b	Product name	1	20210818
7d5b6b15-5a1e-e1e5-992d-90d0701572ad	Product name	9	20210511
ccfbb2ac-2915-4b21-1d79-8a93f773e70f	Product name	9	20200714
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69189-2685-1	2020-01-31	C162847	48780-1	9d75b9d0-5f53-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Dexmethylphenidate Hydrochloride Extended-Release Capsules safely and effectively. See full prescribing information for Dexmethylphenidate Hydrochloride Extended-Release Capsules. Dexmethylphenidate Hydrochloride Extended-Release Capsules CII for oral use Initial U.S. Approval: 2005

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69189-2685-1	Dexmethylphenidate HydrochlorideExtended-Release	1 in 1 DOSE PACK	CAPSULE, EXTENDED RELEASE	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69189-2685	DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [AVERA MCKENNAN HOSPITAL]	1	Legacy NDC, 1 package rows	20160205_c72a641c-6846-4df9-8ff0-fa8036d6ac27.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
Focalin XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	Sandoz Inc	9cf76f62-48aa-4065-94fd-6fc910391ab5	2025-09-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021802 application number: NDA021802
Focalin XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	Novartis Pharmaceuticals Corporation	1a1da905-42a0-4748-9c39-67eca45deccc	2025-09-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021802 application number: NDA021802

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1678OK0E08	DEXMETHYLPHENIDATE HYDROCHLORIDE	19262-68-1	DEXMETHYLPHENIDATE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
899485	dexmethylphenidate HCl 20 MG 24HR Extended Release Oral Capsule	PSN	c72a641c-6846-4df9-8ff0-fa8036d6ac27	1
899485	24 HR dexmethylphenidate hydrochloride 20 MG Extended Release Oral Capsule	SCD	c72a641c-6846-4df9-8ff0-fa8036d6ac27	1
899485	dexmethylphenidate hydrochloride 20 MG 24 HR Extended Release Oral Capsule	SY	c72a641c-6846-4df9-8ff0-fa8036d6ac27	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
69189-2685-1	69189268501	1 in 1 DOSE PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dexmethylphenidate Hydrochloride Extended-Release	Avera McKennan Hospital	2015-12-23	HUMAN PRESCRIPTION DRUG LABEL	1