Dexmethylphenidate Hydrochloride

Product NDC: 0781-2686
Requested package NDC: 0781-2686-01
11-digit product format: 007812686
Labeler code: 0781
Product ID: 0781-2686_f2976909-5df3-4d53-b2f9-e49a840b4cf7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dexmethylphenidate hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Sandoz Inc
Application: NDA021802
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2017-01-05
Marketing end: 0000-00-00
Substance: DEXMETHYLPHENIDATE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0781-2686	0781-2686-01	D	Discontinued by firm		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 · 2 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0781-2686	0781-2686-01	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0781-2686	0781-2686-01	I	Inactivated by FDA		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0781-2686-01	2025-12-01	C162847	48780-1	3b156c62-30b3-fb37-e063-e6dba90a4e07	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, for oral use, CII Initial U.S. Approval: 2005
0781-2686-01	2025-07-29	C162847	48780-1	3b156c62-30b3-fb37-e063-e6dba90a4e07	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, for oral use, CII Initial U.S. Approval: 2005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-2686-01	EA - Each	0781-2686	51fe19ef-1eba-47b2-ac8d-165774023a9b	1	2017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXMETHYLPHENIDATE HYDROCHLORIDE	ACTIVE INGREDIENT	1678OK0E08	DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [SANDOZ INC]	11
DEXMETHYLPHENIDATE	ACTIVE MOIETY	M32RH9MFGP	DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [SANDOZ INC]	11
AMMONIO METHACRYLATE COPOLYMER TYPE A	INACTIVE INGREDIENT	8GQS4E66YY	DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [SANDOZ INC]	11
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [SANDOZ INC]	11
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [SANDOZ INC]	11
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [SANDOZ INC]	11
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [SANDOZ INC]	11
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	INACTIVE INGREDIENT	74G4R6TH13	DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [SANDOZ INC]	11
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [SANDOZ INC]	11
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [SANDOZ INC]	11
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [SANDOZ INC]	11
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [SANDOZ INC]	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0781-2686	DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [SANDOZ INC]	15	Legacy NDC	20200624_77342716-6dd7-488d-bfa4-9637feb4b5f0.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-2686-01	00781268601	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2686-01)	2017-01-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dexmethylphenidate Hydrochloride Extended-Release	Sandoz Inc	2019-11-20	HUMAN PRESCRIPTION DRUG LABEL	15