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 01:29:56

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
50458-335-28	EA - Each	50458-335	34eddb09-315b-4f48-8a4e-e65d50d556b6	1	2012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50458-335	50458-335-28

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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N021444-001	RISPERDAL	RISPERIDONE	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02
N021444-002	RISPERDAL	RISPERIDONE	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02
N021444-003	RISPERDAL	RISPERIDONE	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02
N021444-004	RISPERDAL	RISPERIDONE	3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23
N021444-005	RISPERDAL	RISPERIDONE	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23

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 6 · 215 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	N021444-001	RISPERDAL	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021444-002	RISPERDAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021444-003	RISPERDAL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021444-004	RISPERDAL	3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021444-005	RISPERDAL	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021444-001	RISPERDAL	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021444-002	RISPERDAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021444-003	RISPERDAL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021444-004	RISPERDAL	3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021444-005	RISPERDAL	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021444-001	RISPERDAL	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021444-002	RISPERDAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021444-003	RISPERDAL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021444-004	RISPERDAL	3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021444-005	RISPERDAL	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021444-001	RISPERDAL	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021444-002	RISPERDAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021444-003	RISPERDAL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021444-004	RISPERDAL	3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021444-005	RISPERDAL	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021444-001	RISPERDAL	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021444-002	RISPERDAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021444-003	RISPERDAL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021444-004	RISPERDAL	3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021444-005	RISPERDAL	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021444-001	RISPERDAL	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021444-002	RISPERDAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021444-003	RISPERDAL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021444-004	RISPERDAL	3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021444-005	RISPERDAL	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021444-001	RISPERDAL	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021444-002	RISPERDAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021444-003	RISPERDAL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021444-004	RISPERDAL	3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021444-005	RISPERDAL	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021444-001	RISPERDAL	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021444-002	RISPERDAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021444-003	RISPERDAL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021444-004	RISPERDAL	3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021444-005	RISPERDAL	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`03ed91905a0d…`

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	N021444-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021444-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021444-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021444-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021444-005	AB	1	`74a2ff9319b5…`
2021-03-12 10:30 UTC	2021-03	N021444-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021444-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021444-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021444-004	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021444-005	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021444-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021444-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021444-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021444-004	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021444-005	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021444-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021444-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021444-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021444-004	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021444-005	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021444-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021444-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021444-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021444-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021444-005	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021444-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021444-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021444-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021444-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021444-005	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021444-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021444-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021444-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021444-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021444-005	AB	1	`ea99ee380514…`

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
RISPERDAL	RISPERIDONE	Janssen Pharmaceuticals, Inc.	7e117c7e-02fc-4343-92a1-230061dfc5e0	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (package): 50458-335-28 ndc11 (package): 50458033528

Reported adverse events (FAERS/openFDA)#

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