National Council for Prescription Drug Programs indexing - billing unit

Manufacturer: National Council for Prescription Drug Programs
Effective date: 2012-07-24
Label type: Indexing - Billing Unit
Version: 1
Source: full-release
Hydrated at: 2026-06-05 02:23:26

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0078-0434-05	EA - Each	0078-0434	a482cb43-10c2-4ebe-8139-ef55273dd69a	1	2012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0078-0434	0078-0434-05

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 344 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
2026-09-14 22:38:34	2026-08	N021802-001	FOCALIN XR	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021802-002	FOCALIN XR	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021802-003	FOCALIN XR	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021802-004	FOCALIN XR	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-08-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021802-005	FOCALIN XR	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2009-10-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021802-006	FOCALIN XR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2010-08-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021802-007	FOCALIN XR	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2011-04-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021802-008	FOCALIN XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2011-04-21	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 344 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N021802-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021802-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021802-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021802-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021802-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021802-006	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021802-007	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021802-008	AB	1	`84e616aacf4f…`
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…`

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…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Focalin XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	Novartis Pharmaceuticals Corporation	1a1da905-42a0-4748-9c39-67eca45deccc	2025-09-23	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (package): 0078-0434-05 ndc11 (package): 00078043405

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.