Risperidone

Product NDC: 43063-254
11-digit product format: 430630254
Labeler code: 43063
Product ID: 43063-254_508cb485-b804-3738-e063-6294a90a87ae
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Risperidone
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA079088
Marketing category: ANDA
Marketing start: 2009-01-01
Substance: RISPERIDONE
Active strength: 1 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RISPERIDONE	1 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	L6UH7ZF8HC
Rxcui	312830

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43063-254-30	Risperidone	30 in 1 BOTTLE, PLASTIC	TABLET	30		28
43063-254-60	Risperidone	60 in 1 BOTTLE, PLASTIC	TABLET	60		28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-254-30	EA - Each	43063-254	3183d9f0-4788-452a-85a8-50177c65371f	1	2012-07-24
43063-254-60	EA - Each	43063-254	9ca1b8db-c3ec-4f89-9d8c-41b5487acf04	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
RISPERIDONE	ACTIVE INGREDIENT	L6UH7ZF8HC	RISPERIDONE TABLET [PD-RX PHARMACEUTICALS, INC.]	1
RISPERIDONE	ACTIVE MOIETY	L6UH7ZF8HC	RISPERIDONE TABLET [PD-RX PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43063-254	RISPERIDONE TABLET [PD-RX PHARMACEUTICALS, INC.]	27	Current NDC, Legacy NDC, 2 package rows	20250413_e72a2768-815f-47bf-b2f9-16a93dd10684.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312830	risperiDONE 1 MG Oral Tablet	PSN	e72a2768-815f-47bf-b2f9-16a93dd10684	28
312830	risperidone 1 MG Oral Tablet	SCD	e72a2768-815f-47bf-b2f9-16a93dd10684	28

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-254-30	43063025430	30 TABLET in 1 BOTTLE, PLASTIC (43063-254-30)	30 tablet	2010-06-03	0000-00-00	No	No	Current
43063-254-60	43063025460	60 TABLET in 1 BOTTLE, PLASTIC (43063-254-60)	60 tablet	2010-06-03	0000-00-00	No	No	Current