RISPERIDONE

Product NDC: 63187-642
11-digit product format: 631870642
Labeler code: 63187
Product ID: 63187-642_e3793e49-cf4b-4bf3-a89a-bd9deaf2be61
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: RISPERIDONE
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA201003
Marketing category: ANDA
Marketing start: 2015-09-09
Substance: RISPERIDONE
Active strength: .5 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RISPERIDONE	.5 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	L6UH7ZF8HC
Rxcui	312829

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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63187-642-30	RISPERIDONE	30 in 1 BOTTLE	TABLET	30		4
63187-642-60	RISPERIDONE	60 in 1 BOTTLE	TABLET	60		4
63187-642-90	RISPERIDONE	90 in 1 BOTTLE	TABLET	90		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-642-30	EA - Each	63187-642	f0e1290a-09a2-4f66-b249-6f4bff55e29d	1	2022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-642	RISPERIDONE TABLET [PROFICIENT RX LP]	4	Current NDC, Legacy NDC, 3 package rows	20221027_1b5c9889-4dc3-48df-8629-4ac099e2b4c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312829	risperiDONE 0.5 MG Oral Tablet	PSN	1b5c9889-4dc3-48df-8629-4ac099e2b4c0	4
312829	risperidone 0.5 MG Oral Tablet	SCD	1b5c9889-4dc3-48df-8629-4ac099e2b4c0	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-642-30	63187064230	30 TABLET in 1 BOTTLE (63187-642-30)	30 tablet	2018-12-01	0000-00-00	No	No	Current
63187-642-60	63187064260	60 TABLET in 1 BOTTLE (63187-642-60)	60 tablet	2018-12-01	0000-00-00	No	No	Current
63187-642-90	63187064290	90 TABLET in 1 BOTTLE (63187-642-90)	90 tablet	2018-12-01	0000-00-00	No	No	Current