Risperidone

Product NDC: 59746-050
11-digit product format: 597460050
Labeler code: 59746
Product ID: 59746-050_90b80768-87f7-4fb1-8142-909dba9555e2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Risperidone
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Jubilant Cadista Pharmacuticals Inc.
Application: ANDA090839
Marketing category: ANDA
Marketing start: 2011-11-04
Substance: RISPERIDONE
Active strength: 4 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	TE codes	RLD / RS	Approval date
A090839-001	RISPERIDONE	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2011-11-04
A090839-002	RISPERIDONE	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2011-11-04
A090839-003	RISPERIDONE	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2011-11-04
A090839-004	RISPERIDONE	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2011-11-04
A090839-005	RISPERIDONE	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2011-11-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090839-001	AB
A090839-002	AB
A090839-003	AB
A090839-004	AB
A090839-005	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 6 · 215 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	A090839-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2011-11-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090839-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2011-11-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090839-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2011-11-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090839-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2011-11-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090839-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2011-11-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090839-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2011-11-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090839-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2011-11-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090839-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2011-11-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090839-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2011-11-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090839-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2011-11-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090839-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2011-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090839-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2011-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090839-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2011-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090839-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2011-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090839-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2011-11-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090839-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2011-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090839-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2011-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090839-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2011-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090839-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2011-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090839-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2011-11-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090839-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2011-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090839-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2011-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090839-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2011-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090839-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2011-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090839-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2011-11-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090839-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2011-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090839-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2011-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090839-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2011-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090839-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2011-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090839-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2011-11-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090839-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2011-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090839-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2011-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090839-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2011-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090839-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2011-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090839-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2011-11-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090839-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2011-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090839-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2011-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090839-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2011-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090839-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2011-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090839-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2011-11-04	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 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	A090839-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090839-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090839-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090839-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090839-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090839-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090839-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090839-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090839-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090839-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090839-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090839-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090839-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090839-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090839-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090839-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090839-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090839-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090839-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090839-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090839-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090839-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090839-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090839-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090839-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090839-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090839-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090839-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090839-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090839-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090839-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090839-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090839-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090839-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090839-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090839-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090839-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090839-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090839-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090839-005	AB	1	`03ed91905a0d…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Risperidone
Listing expiration: 2026-12-31

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 · 5 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

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
739dcf8a-ed73-5eb0-899b-7e51cb73c335	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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2023-02-28	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, for oral use Initial U.S. Approval: 1993
2023-02-28	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, for oral use Initial U.S. Approval: 1993
2023-01-30	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, for oral use Initial U.S. Approval: 1993
2023-01-30	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, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59746-050-22	Risperidone	4 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	4		25
59746-050-22	Risperidone	7 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	7		25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59746-050-22	EA - Each	59746-050	7ca1df18-0e03-4f56-8920-df1d19224f1f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Risperidone	ACTIVE INGREDIENT	L6UH7ZF8HC	RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]	11
Risperidone	ACTIVE MOIETY	L6UH7ZF8HC	RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]	11
Acesulfame Potassium	INACTIVE INGREDIENT	23OV73Q5G9	RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]	11
Aspartame	INACTIVE INGREDIENT	Z0H242BBR1	RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]	11
Dimethylaminoethyl Methacrylate - Butyl Methacrylate - Methyl Methacrylate Copolymer	INACTIVE INGREDIENT	905HNO1SIH	RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]	11
Fd&c Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]	11
Fd&c Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]	11
Ferric Oxide Red	INACTIVE INGREDIENT	1K09F3G675	RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]	11
Ferric Oxide Yellow	INACTIVE INGREDIENT	EX438O2MRT	RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]	11
Hydroxypropyl Cellulose, Low Substituted	INACTIVE INGREDIENT	2165RE0K14	RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]	11
Magnesium Aluminometasilicate Type I-a	INACTIVE INGREDIENT	7LVU907546	RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]	11
Mannitol	INACTIVE INGREDIENT	3OWL53L36A	RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]	11
Peppermint	INACTIVE INGREDIENT	V95R5KMY2B	RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]	11
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]	11
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]	11
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]	11
Sodium Stearyl Fumarate	INACTIVE INGREDIENT	7CV7WJK4UI	RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]	11
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59746-050	RISPERIDONE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACUTICALS INC.]	24	Current NDC, Legacy NDC, 2 package rows	20250519_739dcf8a-ed73-5eb0-899b-7e51cb73c335.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	Jubilant Cadista Pharmacuticals Inc.	739dcf8a-ed73-5eb0-899b-7e51cb73c335	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090839 application number: ANDA090839 ndc (product): 59746-050

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
403825	risperiDONE 0.5 MG Disintegrating Oral Tablet	PSN	739dcf8a-ed73-5eb0-899b-7e51cb73c335	25
401953	risperiDONE 1 MG Disintegrating Oral Tablet	PSN	739dcf8a-ed73-5eb0-899b-7e51cb73c335	25
401954	risperiDONE 2 MG Disintegrating Oral Tablet	PSN	739dcf8a-ed73-5eb0-899b-7e51cb73c335	25
616698	risperiDONE 3 MG Disintegrating Oral Tablet	PSN	739dcf8a-ed73-5eb0-899b-7e51cb73c335	25
616705	risperiDONE 4 MG Disintegrating Oral Tablet	PSN	739dcf8a-ed73-5eb0-899b-7e51cb73c335	25
403825	risperidone 0.5 MG Disintegrating Oral Tablet	SCD	739dcf8a-ed73-5eb0-899b-7e51cb73c335	25
401953	risperidone 1 MG Disintegrating Oral Tablet	SCD	739dcf8a-ed73-5eb0-899b-7e51cb73c335	25
401954	risperidone 2 MG Disintegrating Oral Tablet	SCD	739dcf8a-ed73-5eb0-899b-7e51cb73c335	25
616698	risperidone 3 MG Disintegrating Oral Tablet	SCD	739dcf8a-ed73-5eb0-899b-7e51cb73c335	25
616705	risperidone 4 MG Disintegrating Oral Tablet	SCD	739dcf8a-ed73-5eb0-899b-7e51cb73c335	25

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59746-050-22	59746005022	7 BLISTER PACK in 1 CARTON (59746-050-22) / 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	7 blister pack	2011-11-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Risperidone	Jubilant Cadista Pharmacuticals Inc. \| Jubilant Generics Limited	2025-10-08	Human Prescription Drug Label	25