Focalin

Product NDC: 0078-0431
11-digit product format: 000780431
Labeler code: 0078
Product ID: 0078-0431_fd5dd3b3-6bdf-437e-a763-1a07f9631121
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dexmethylphenidate hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Novartis Pharmaceuticals Corporation
Application: NDA021802
Marketing category: NDA
Marketing start: 2005-05-31
Marketing end: 2026-12-31
Substance: DEXMETHYLPHENIDATE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule: CII
NDC exclude flag: No
Current FDA listing: Yes

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	0078-0431	0078-0431-05	D	Discontinued by firm		2026-08-17

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Focalin
Brand name suffix: XR

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXMETHYLPHENIDATE HYDROCHLORIDE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1678OK0E08	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 16 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
899439	Internal RxNorm lookup
899441	Internal RxNorm lookup
899461	Internal RxNorm lookup
899463	Internal RxNorm lookup
899485	Internal RxNorm lookup
899487	Internal RxNorm lookup
899495	Internal RxNorm lookup
899497	Internal RxNorm lookup
899511	Internal RxNorm lookup
899513	Internal RxNorm lookup
1006608	Internal RxNorm lookup
1006610	Internal RxNorm lookup
1101926	Internal RxNorm lookup
1101928	Internal RxNorm lookup
1101932	Internal RxNorm lookup
1101934	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
1a1da905-42a0-4748-9c39-67eca45deccc	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0078-0431-05	FocalinXR	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100		36

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0078-0431-05	EA - Each	0078-0431	1a3542d7-524f-41d6-a878-88f6ecb05f44	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXMETHYLPHENIDATE HYDROCHLORIDE	ACTIVE INGREDIENT	1678OK0E08	FOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	21
DEXMETHYLPHENIDATE	ACTIVE MOIETY	M32RH9MFGP	FOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	21
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	FOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	21
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	FOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	21
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	21
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	21
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	FOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	21
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	FOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	21
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	21
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	FOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	21
DEXMETHYLPHENIDATE HYDROCHLORIDE	ACTIVE INGREDIENT	1678OK0E08	FOCALINXR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
DEXMETHYLPHENIDATE	ACTIVE MOIETY	M32RH9MFGP	FOCALINXR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	FOCALINXR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	FOCALINXR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FOCALINXR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FOCALINXR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	FOCALINXR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	FOCALINXR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FOCALINXR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	FOCALINXR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0078-0431	FOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	34	Current NDC, Legacy NDC, 1 package rows	20231030_1a1da905-42a0-4748-9c39-67eca45deccc.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 ndc (product): 0078-0431

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
899439	dexmethylphenidate HCl 10 MG 24HR Extended Release Oral Capsule	PSN	1a1da905-42a0-4748-9c39-67eca45deccc	36
899461	dexmethylphenidate HCl 15 MG 24HR Extended Release Oral Capsule	PSN	1a1da905-42a0-4748-9c39-67eca45deccc	36
899485	dexmethylphenidate HCl 20 MG 24HR Extended Release Oral Capsule	PSN	1a1da905-42a0-4748-9c39-67eca45deccc	36
1101926	dexmethylphenidate HCl 25 MG 24HR Extended Release Oral Capsule	PSN	1a1da905-42a0-4748-9c39-67eca45deccc	36
899495	dexmethylphenidate HCl 30 MG 24HR Extended Release Oral Capsule	PSN	1a1da905-42a0-4748-9c39-67eca45deccc	36
1101932	dexmethylphenidate HCl 35 MG 24HR Extended Release Oral Capsule	PSN	1a1da905-42a0-4748-9c39-67eca45deccc	36
1006608	dexmethylphenidate HCl 40 MG 24HR Extended Release Oral Capsule	PSN	1a1da905-42a0-4748-9c39-67eca45deccc	36
899511	dexmethylphenidate HCl 5 MG 24HR Extended Release Oral Capsule	PSN	1a1da905-42a0-4748-9c39-67eca45deccc	36
899441	Focalin XR 10 MG 24HR Extended Release Oral Capsule	PSN	1a1da905-42a0-4748-9c39-67eca45deccc	36
899463	Focalin XR 15 MG 24HR Extended Release Oral Capsule	PSN	1a1da905-42a0-4748-9c39-67eca45deccc	36
899487	Focalin XR 20 MG 24HR Extended Release Oral Capsule	PSN	1a1da905-42a0-4748-9c39-67eca45deccc	36
1101928	Focalin XR 25 MG 24HR Extended Release Oral Capsule	PSN	1a1da905-42a0-4748-9c39-67eca45deccc	36
899497	Focalin XR 30 MG 24HR Extended Release Oral Capsule	PSN	1a1da905-42a0-4748-9c39-67eca45deccc	36
1101934	Focalin XR 35 MG 24HR Extended Release Oral Capsule	PSN	1a1da905-42a0-4748-9c39-67eca45deccc	36
1006610	Focalin XR 40 MG 24HR Extended Release Oral Capsule	PSN	1a1da905-42a0-4748-9c39-67eca45deccc	36
899513	Focalin XR 5 MG 24HR Extended Release Oral Capsule	PSN	1a1da905-42a0-4748-9c39-67eca45deccc	36
899441	24 HR dexmethylphenidate hydrochloride 10 MG Extended Release Oral Capsule [Focalin]	SBD	1a1da905-42a0-4748-9c39-67eca45deccc	36
899463	24 HR dexmethylphenidate hydrochloride 15 MG Extended Release Oral Capsule [Focalin]	SBD	1a1da905-42a0-4748-9c39-67eca45deccc	36
899487	24 HR dexmethylphenidate hydrochloride 20 MG Extended Release Oral Capsule [Focalin]	SBD	1a1da905-42a0-4748-9c39-67eca45deccc	36
1101928	24 HR dexmethylphenidate hydrochloride 25 MG Extended Release Oral Capsule [Focalin]	SBD	1a1da905-42a0-4748-9c39-67eca45deccc	36
899497	24 HR dexmethylphenidate hydrochloride 30 MG Extended Release Oral Capsule [Focalin]	SBD	1a1da905-42a0-4748-9c39-67eca45deccc	36
1101934	24 HR dexmethylphenidate hydrochloride 35 MG Extended Release Oral Capsule [Focalin]	SBD	1a1da905-42a0-4748-9c39-67eca45deccc	36
1006610	24 HR dexmethylphenidate hydrochloride 40 MG Extended Release Oral Capsule [Focalin]	SBD	1a1da905-42a0-4748-9c39-67eca45deccc	36
899513	24 HR dexmethylphenidate hydrochloride 5 MG Extended Release Oral Capsule [Focalin]	SBD	1a1da905-42a0-4748-9c39-67eca45deccc	36
899439	24 HR dexmethylphenidate hydrochloride 10 MG Extended Release Oral Capsule	SCD	1a1da905-42a0-4748-9c39-67eca45deccc	36
899461	24 HR dexmethylphenidate hydrochloride 15 MG Extended Release Oral Capsule	SCD	1a1da905-42a0-4748-9c39-67eca45deccc	36
899485	24 HR dexmethylphenidate hydrochloride 20 MG Extended Release Oral Capsule	SCD	1a1da905-42a0-4748-9c39-67eca45deccc	36
1101926	24 HR dexmethylphenidate hydrochloride 25 MG Extended Release Oral Capsule	SCD	1a1da905-42a0-4748-9c39-67eca45deccc	36
899495	24 HR dexmethylphenidate hydrochloride 30 MG Extended Release Oral Capsule	SCD	1a1da905-42a0-4748-9c39-67eca45deccc	36
1101932	24 HR dexmethylphenidate hydrochloride 35 MG Extended Release Oral Capsule	SCD	1a1da905-42a0-4748-9c39-67eca45deccc	36
1006608	24 HR dexmethylphenidate hydrochloride 40 MG Extended Release Oral Capsule	SCD	1a1da905-42a0-4748-9c39-67eca45deccc	36
899511	24 HR dexmethylphenidate hydrochloride 5 MG Extended Release Oral Capsule	SCD	1a1da905-42a0-4748-9c39-67eca45deccc	36
899441	24 HR Focalin 10 MG Extended Release Oral Capsule	SY	1a1da905-42a0-4748-9c39-67eca45deccc	36
899463	24 HR Focalin 15 MG Extended Release Oral Capsule	SY	1a1da905-42a0-4748-9c39-67eca45deccc	36
899487	24 HR Focalin 20 MG Extended Release Oral Capsule	SY	1a1da905-42a0-4748-9c39-67eca45deccc	36
1101928	24 HR Focalin 25 MG Extended Release Oral Capsule	SY	1a1da905-42a0-4748-9c39-67eca45deccc	36
899497	24 HR Focalin 30 MG Extended Release Oral Capsule	SY	1a1da905-42a0-4748-9c39-67eca45deccc	36
1101934	24 HR Focalin 35 MG Extended Release Oral Capsule	SY	1a1da905-42a0-4748-9c39-67eca45deccc	36
1006610	24 HR Focalin 40 MG Extended Release Oral Capsule	SY	1a1da905-42a0-4748-9c39-67eca45deccc	36
899513	24 HR Focalin 5 MG Extended Release Oral Capsule	SY	1a1da905-42a0-4748-9c39-67eca45deccc	36
899439	dexmethylphenidate hydrochloride 10 MG 24 HR Extended Release Oral Capsule	SY	1a1da905-42a0-4748-9c39-67eca45deccc	36
899461	dexmethylphenidate hydrochloride 15 MG 24 HR Extended Release Oral Capsule	SY	1a1da905-42a0-4748-9c39-67eca45deccc	36
899485	dexmethylphenidate hydrochloride 20 MG 24 HR Extended Release Oral Capsule	SY	1a1da905-42a0-4748-9c39-67eca45deccc	36
1101926	dexmethylphenidate hydrochloride 25 MG 24 HR Extended Release Oral Capsule	SY	1a1da905-42a0-4748-9c39-67eca45deccc	36
899495	dexmethylphenidate hydrochloride 30 MG 24 HR Extended Release Oral Capsule	SY	1a1da905-42a0-4748-9c39-67eca45deccc	36
1101932	dexmethylphenidate hydrochloride 35 MG 24 HR Extended Release Oral Capsule	SY	1a1da905-42a0-4748-9c39-67eca45deccc	36
1006608	dexmethylphenidate hydrochloride 40 MG 24 HR Extended Release Oral Capsule	SY	1a1da905-42a0-4748-9c39-67eca45deccc	36
899511	dexmethylphenidate hydrochloride 5 MG 24 HR Extended Release Oral Capsule	SY	1a1da905-42a0-4748-9c39-67eca45deccc	36
899441	Focalin XR 10 MG 24 HR Extended Release Oral Capsule	SY	1a1da905-42a0-4748-9c39-67eca45deccc	36
899463	Focalin XR 15 MG 24 HR Extended Release Oral Capsule	SY	1a1da905-42a0-4748-9c39-67eca45deccc	36
899487	Focalin XR 20 MG 24 HR Extended Release Oral Capsule	SY	1a1da905-42a0-4748-9c39-67eca45deccc	36
1101928	Focalin XR 25 MG 24 HR Extended Release Oral Capsule	SY	1a1da905-42a0-4748-9c39-67eca45deccc	36
899497	Focalin XR 30 MG 24 HR Extended Release Oral Capsule	SY	1a1da905-42a0-4748-9c39-67eca45deccc	36
1101934	Focalin XR 35 MG 24 HR Extended Release Oral Capsule	SY	1a1da905-42a0-4748-9c39-67eca45deccc	36
1006610	Focalin XR 40 MG 24 HR Extended Release Oral Capsule	SY	1a1da905-42a0-4748-9c39-67eca45deccc	36
899513	Focalin XR 5 MG 24 HR Extended Release Oral Capsule	SY	1a1da905-42a0-4748-9c39-67eca45deccc	36
899439	dexmethylphenidate HCl 10 MG 24HR Extended Release Oral Capsule	PSN	00f1d83e-93cc-4bbe-9c3b-c488062271ab	2
899461	dexmethylphenidate HCl 15 MG 24HR Extended Release Oral Capsule	PSN	00f1d83e-93cc-4bbe-9c3b-c488062271ab	2
899485	dexmethylphenidate HCl 20 MG 24HR Extended Release Oral Capsule	PSN	00f1d83e-93cc-4bbe-9c3b-c488062271ab	2
899511	dexmethylphenidate HCl 5 MG 24HR Extended Release Oral Capsule	PSN	00f1d83e-93cc-4bbe-9c3b-c488062271ab	2
899441	Focalin XR 10 MG 24HR Extended Release Oral Capsule	PSN	00f1d83e-93cc-4bbe-9c3b-c488062271ab	2
899463	Focalin XR 15 MG 24HR Extended Release Oral Capsule	PSN	00f1d83e-93cc-4bbe-9c3b-c488062271ab	2
899487	Focalin XR 20 MG 24HR Extended Release Oral Capsule	PSN	00f1d83e-93cc-4bbe-9c3b-c488062271ab	2
899513	Focalin XR 5 MG 24HR Extended Release Oral Capsule	PSN	00f1d83e-93cc-4bbe-9c3b-c488062271ab	2
899441	24 HR dexmethylphenidate hydrochloride 10 MG Extended Release Oral Capsule [Focalin]	SBD	00f1d83e-93cc-4bbe-9c3b-c488062271ab	2
899463	24 HR dexmethylphenidate hydrochloride 15 MG Extended Release Oral Capsule [Focalin]	SBD	00f1d83e-93cc-4bbe-9c3b-c488062271ab	2
899487	24 HR dexmethylphenidate hydrochloride 20 MG Extended Release Oral Capsule [Focalin]	SBD	00f1d83e-93cc-4bbe-9c3b-c488062271ab	2
899513	24 HR dexmethylphenidate hydrochloride 5 MG Extended Release Oral Capsule [Focalin]	SBD	00f1d83e-93cc-4bbe-9c3b-c488062271ab	2
899439	24 HR dexmethylphenidate hydrochloride 10 MG Extended Release Oral Capsule	SCD	00f1d83e-93cc-4bbe-9c3b-c488062271ab	2
899461	24 HR dexmethylphenidate hydrochloride 15 MG Extended Release Oral Capsule	SCD	00f1d83e-93cc-4bbe-9c3b-c488062271ab	2
899485	24 HR dexmethylphenidate hydrochloride 20 MG Extended Release Oral Capsule	SCD	00f1d83e-93cc-4bbe-9c3b-c488062271ab	2
899511	24 HR dexmethylphenidate hydrochloride 5 MG Extended Release Oral Capsule	SCD	00f1d83e-93cc-4bbe-9c3b-c488062271ab	2
899441	24 HR Focalin 10 MG Extended Release Oral Capsule	SY	00f1d83e-93cc-4bbe-9c3b-c488062271ab	2
899463	24 HR Focalin 15 MG Extended Release Oral Capsule	SY	00f1d83e-93cc-4bbe-9c3b-c488062271ab	2
899487	24 HR Focalin 20 MG Extended Release Oral Capsule	SY	00f1d83e-93cc-4bbe-9c3b-c488062271ab	2
899513	24 HR Focalin 5 MG Extended Release Oral Capsule	SY	00f1d83e-93cc-4bbe-9c3b-c488062271ab	2
899439	dexmethylphenidate hydrochloride 10 MG 24 HR Extended Release Oral Capsule	SY	00f1d83e-93cc-4bbe-9c3b-c488062271ab	2
899461	dexmethylphenidate hydrochloride 15 MG 24 HR Extended Release Oral Capsule	SY	00f1d83e-93cc-4bbe-9c3b-c488062271ab	2
899485	dexmethylphenidate hydrochloride 20 MG 24 HR Extended Release Oral Capsule	SY	00f1d83e-93cc-4bbe-9c3b-c488062271ab	2
899511	dexmethylphenidate hydrochloride 5 MG 24 HR Extended Release Oral Capsule	SY	00f1d83e-93cc-4bbe-9c3b-c488062271ab	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0078-0431-05	00078043105	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0431-05)	2005-05-31	2026-06-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Focalin XR	Novartis Pharmaceuticals Corporation	2025-09-23	HUMAN PRESCRIPTION DRUG LABEL	36
FocalinXR	Physicians Total Care, Inc.	2010-11-11	HUMAN PRESCRIPTION DRUG LABEL	2