National Council for Prescription Drug Programs indexing - billing unit

Manufacturer: National Council for Prescription Drug Programs
Effective date: 2013-02-13
Label type: Indexing - Billing Unit
Version: 1
Source: full-release
Hydrated at: 2026-06-05 03:19:46

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
0093-3010-01	EA - Each	0093-3010	a6928fa6-e530-4521-9414-85bdcbc80ae7	1	2013-02-13

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0093-3010	0093-3010-01

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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N021590-001	FAZACLO ODT	CLOZAPINE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-02-10
N021590-002	FAZACLO ODT	CLOZAPINE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-02-10
N021590-003	FAZACLO ODT	CLOZAPINE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-06-03
N021590-004	FAZACLO ODT	CLOZAPINE	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-05-30
N021590-005	FAZACLO ODT	CLOZAPINE	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2010-07-09
N021590-006	FAZACLO ODT	CLOZAPINE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2010-07-09

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 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021590-001	FAZACLO ODT	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021590-002	FAZACLO ODT	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021590-003	FAZACLO ODT	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-06-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021590-004	FAZACLO ODT	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-05-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021590-005	FAZACLO ODT	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2010-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021590-006	FAZACLO ODT	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2010-07-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021590-001	FAZACLO ODT	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021590-002	FAZACLO ODT	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021590-003	FAZACLO ODT	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021590-004	FAZACLO ODT	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-05-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021590-005	FAZACLO ODT	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2010-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021590-006	FAZACLO ODT	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2010-07-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021590-001	FAZACLO ODT	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021590-002	FAZACLO ODT	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021590-003	FAZACLO ODT	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021590-004	FAZACLO ODT	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021590-005	FAZACLO ODT	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2010-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021590-006	FAZACLO ODT	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2010-07-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021590-001	FAZACLO ODT	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021590-002	FAZACLO ODT	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021590-003	FAZACLO ODT	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021590-004	FAZACLO ODT	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021590-005	FAZACLO ODT	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2010-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021590-006	FAZACLO ODT	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2010-07-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021590-001	FAZACLO ODT	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021590-002	FAZACLO ODT	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021590-003	FAZACLO ODT	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		2005-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021590-004	FAZACLO ODT	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021590-005	FAZACLO ODT	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2010-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021590-006	FAZACLO ODT	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2010-07-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021590-001	FAZACLO ODT	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021590-002	FAZACLO ODT	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021590-003	FAZACLO ODT	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		2005-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021590-004	FAZACLO ODT	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021590-005	FAZACLO ODT	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2010-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021590-006	FAZACLO ODT	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2010-07-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021590-001	FAZACLO ODT	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021590-002	FAZACLO ODT	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021590-003	FAZACLO ODT	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		2005-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021590-004	FAZACLO ODT	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-05-30	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021590-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021590-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021590-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021590-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021590-006	AB	1	`74a2ff9319b5…`
2019-09-15 20:21 UTC	2019-09	N021590-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021590-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021590-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021590-005	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021590-006	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021590-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021590-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021590-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021590-005	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021590-006	AB	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

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