Risperidone

Product NDC: 49884-403
11-digit product format: 498840403
Labeler code: 49884
Product ID: 49884-403_3bd8b953-b579-4044-a5e7-b07d113738d4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Risperidone
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Par Health USA, LLC
Application: ANDA077494
Marketing category: ANDA
Marketing start: 2009-06-10
Substance: RISPERIDONE
Active strength: 4 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product	49884-403		I	Inactivated by FDA		excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	49884-403	49884-403-91	I	Inactivated by FDA		excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	TE codes	Approval date
A077494-001	RISPERIDONE	RISPERIDONE	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL		2009-04-30
A077494-002	RISPERIDONE	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30
A077494-003	RISPERIDONE	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-10-26
A077494-004	RISPERIDONE	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30
A077494-005	RISPERIDONE	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30
A077494-006	RISPERIDONE	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A077494-002	AB
A077494-003	AB
A077494-004	AB
A077494-005	AB
A077494-006	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 7 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077494-001	RISPERIDONE	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL		2009-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077494-002	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077494-003	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077494-004	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077494-005	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077494-006	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077494-001	RISPERIDONE	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL		2009-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077494-002	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077494-003	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077494-004	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077494-005	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077494-006	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077494-001	RISPERIDONE	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL		2009-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077494-002	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077494-003	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077494-004	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077494-005	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077494-006	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077494-001	RISPERIDONE	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL		2009-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077494-002	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077494-003	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077494-004	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077494-005	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077494-006	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077494-001	RISPERIDONE	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL		2009-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077494-002	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077494-003	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077494-004	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077494-005	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077494-006	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077494-001	RISPERIDONE	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL		2009-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077494-002	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077494-003	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077494-004	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077494-005	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077494-006	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077494-001	RISPERIDONE	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL		2009-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077494-002	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077494-003	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077494-004	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077494-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077494-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077494-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077494-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077494-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077494-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077494-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077494-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077494-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077494-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077494-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077494-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077494-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077494-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077494-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077494-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077494-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077494-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077494-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077494-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077494-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077494-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077494-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077494-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077494-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077494-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077494-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077494-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077494-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077494-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077494-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077494-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077494-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077494-005	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077494-006	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077494-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077494-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077494-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077494-005	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077494-006	AB	1	`5bbf6a4d5a75…`

Additional Listing Data#

Finished product: Yes
Brand name base: Risperidone
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RISPERIDONE	4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L6UH7ZF8HC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
401953	Internal RxNorm lookup
401954	Internal RxNorm lookup
403825	Internal RxNorm lookup
616698	Internal RxNorm lookup
616705	Internal RxNorm lookup
645037	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
d0ef6df3-67e5-47b1-bcf7-f67aa030caca	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6ab2126a-0ca2-c16c-ab6d-b3a031ba7ac6	Product name	5	20250303
0efa9fd6-2fb6-4cd3-8b0f-2a2bf9c4a09e	Product name	1	20250128
e457a910-2c3a-4bfd-90b9-0310982c50dd	Product name	1	20241218
42b1a2d5-888a-4386-ab9f-0979e0d7b4aa	Product name	1	20231010
66685e90-862d-4873-a0c5-2be73b803c36	Product name	1	20230921
92d220a1-2a4c-4393-9080-7335ca8223cc	Product name	1	20230823
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49884-403-91	2022-09-27	C162847	48780-1	e4f33bdf-a4d4-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RISPERIDONE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for RISPERIDONE ORALLY DISINTEGRATING TABLETS. RISPERIDONE orally disintegrating tablets Initial U.S. Approval: 1993
49884-403-91	2022-07-29	C162847	48780-1	e4f33bdf-a4d4-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RISPERIDONE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for RISPERIDONE ORALLY DISINTEGRATING TABLETS. RISPERIDONE orally disintegrating tablets Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49884-403-52	Risperidone	4 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	4		32
49884-403-91	Risperidone	7 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	7		32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49884-403-52	EA - Each	49884-403	9e535776-88c7-4d06-9185-0d3fb47d51fa	1	2013-02-13
49884-403-91	EA - Each	49884-403	4c5e85d9-e62f-468e-823f-2211da6e2278	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RISPERIDONE	ACTIVE INGREDIENT	L6UH7ZF8HC	RISPERIDONE TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL COMPANIES, INC.]	15
RISPERIDONE	ACTIVE MOIETY	L6UH7ZF8HC	RISPERIDONE TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL COMPANIES, INC.]	15
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	RISPERIDONE TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL COMPANIES, INC.]	15
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	RISPERIDONE TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL COMPANIES, INC.]	15
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	RISPERIDONE TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL COMPANIES, INC.]	15
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RISPERIDONE TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL COMPANIES, INC.]	15
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	RISPERIDONE TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL COMPANIES, INC.]	15
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	RISPERIDONE TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL COMPANIES, INC.]	15
SORBITOL	INACTIVE INGREDIENT	506T60A25R	RISPERIDONE TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL COMPANIES, INC.]	15
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	RISPERIDONE TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL COMPANIES, INC.]	15
TARTARIC ACID	INACTIVE INGREDIENT	W4888I119H	RISPERIDONE TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL COMPANIES, INC.]	15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49884-403	RISPERIDONE TABLET, ORALLY DISINTEGRATING [ENDO USA, INC.]	28	Current NDC, Legacy NDC, 2 package rows	20250524_d0ef6df3-67e5-47b1-bcf7-f67aa030caca.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Risperidone	RISPERIDONE	Par Health USA, LLC	d0ef6df3-67e5-47b1-bcf7-f67aa030caca	2024-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077494 application number: ANDA077494 ndc (product): 49884-403

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L6UH7ZF8HC	RISPERIDONE	106266-06-2	RISPERIDONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
645037	risperiDONE 0.25 MG Disintegrating Oral Tablet	PSN	d0ef6df3-67e5-47b1-bcf7-f67aa030caca	32
403825	risperiDONE 0.5 MG Disintegrating Oral Tablet	PSN	d0ef6df3-67e5-47b1-bcf7-f67aa030caca	32
401953	risperiDONE 1 MG Disintegrating Oral Tablet	PSN	d0ef6df3-67e5-47b1-bcf7-f67aa030caca	32
401954	risperiDONE 2 MG Disintegrating Oral Tablet	PSN	d0ef6df3-67e5-47b1-bcf7-f67aa030caca	32
616698	risperiDONE 3 MG Disintegrating Oral Tablet	PSN	d0ef6df3-67e5-47b1-bcf7-f67aa030caca	32
616705	risperiDONE 4 MG Disintegrating Oral Tablet	PSN	d0ef6df3-67e5-47b1-bcf7-f67aa030caca	32
645037	risperidone 0.25 MG Disintegrating Oral Tablet	SCD	d0ef6df3-67e5-47b1-bcf7-f67aa030caca	32
403825	risperidone 0.5 MG Disintegrating Oral Tablet	SCD	d0ef6df3-67e5-47b1-bcf7-f67aa030caca	32
401953	risperidone 1 MG Disintegrating Oral Tablet	SCD	d0ef6df3-67e5-47b1-bcf7-f67aa030caca	32
401954	risperidone 2 MG Disintegrating Oral Tablet	SCD	d0ef6df3-67e5-47b1-bcf7-f67aa030caca	32
616698	risperidone 3 MG Disintegrating Oral Tablet	SCD	d0ef6df3-67e5-47b1-bcf7-f67aa030caca	32
616705	risperidone 4 MG Disintegrating Oral Tablet	SCD	d0ef6df3-67e5-47b1-bcf7-f67aa030caca	32

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49884-403-52	49884040352	4 in 1 BLISTER PACK						Historical
49884-403-91	49884040391	7 BLISTER PACK in 1 CARTON (49884-403-91) / 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (49884-403-52)	7 blister pack	2009-06-10	0000-00-00	No	No	Current