Risperidone

Product NDC: 13668-038
11-digit product format: 136680038
Labeler code: 13668
Product ID: 13668-038_cd8bfb14-7054-4c69-b27f-8a960b5ecb5f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Risperidone
Dosage form: TABLET
Route: ORAL
Labeler: Torrent Pharmaceuticals Limited
Application: ANDA079088
Marketing category: ANDA
Marketing start: 2009-01-01
Substance: RISPERIDONE
Active strength: 2 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	2 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	L6UH7ZF8HC
Rxcui	312828, 312829, 312830, 312831, 312832, 314211

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	SPL version
13668-038-01	Risperidone	100 in 1 BOTTLE	TABLET	100	25
13668-038-05	Risperidone	500 in 1 BOTTLE	TABLET	500	25
13668-038-55	Risperidone	4200 in 1 BOTTLE	TABLET	4200	25
13668-038-60	Risperidone	60 in 1 BOTTLE	TABLET	60	25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13668-038-01	EA - Each	13668-038	60e65b2b-8626-42b1-a6df-d58cd7e865c5	1	2012-07-24
13668-038-05	EA - Each	13668-038	ca674f3f-edd4-4560-92f8-6c1b1d5bee82	1	2012-07-24
13668-038-60	EA - Each	13668-038	304f4aac-b23d-43b7-b3e0-30348c13f31c	1	2012-07-24
13668-038-74	EA - Each	13668-038	7f582b58-7704-46d1-8e7b-db542309eb76	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RISPERIDONE	ACTIVE INGREDIENT	L6UH7ZF8HC	RISPERIDONE TABLET [TORRENT PHARMACEUTICALS LIMITED]	12
RISPERIDONE	ACTIVE MOIETY	L6UH7ZF8HC	RISPERIDONE TABLET [TORRENT PHARMACEUTICALS LIMITED]	12
RISPERIDONE	ACTIVE INGREDIENT	L6UH7ZF8HC	RISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC]	5
RISPERIDONE	ACTIVE MOIETY	L6UH7ZF8HC	RISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC]	5
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	RISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC]	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	RISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC]	5
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	RISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC]	5
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	RISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	RISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC]	5
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	RISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	RISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC]	5
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	RISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	RISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	RISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC]	5
RISPERIDONE	ACTIVE INGREDIENT	L6UH7ZF8HC	RISPERIDONE TABLET [H.J. HARKINS COMPANY, INC.]	3
RISPERIDONE	ACTIVE MOIETY	L6UH7ZF8HC	RISPERIDONE TABLET [H.J. HARKINS COMPANY, INC.]	3
RISPERIDONE	ACTIVE INGREDIENT	L6UH7ZF8HC	RISPERIDONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
RISPERIDONE	ACTIVE INGREDIENT	L6UH7ZF8HC	RISPERIDONE TABLET [REBEL DISTRIBUTORS CORP]	1
RISPERIDONE	ACTIVE INGREDIENT	L6UH7ZF8HC	RISPERIDONE TABLET [STAT RX USA LLC]	1
RISPERIDONE	ACTIVE MOIETY	L6UH7ZF8HC	RISPERIDONE TABLET [REBEL DISTRIBUTORS CORP]	1
RISPERIDONE	ACTIVE MOIETY	L6UH7ZF8HC	RISPERIDONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
RISPERIDONE	ACTIVE MOIETY	L6UH7ZF8HC	RISPERIDONE TABLET [STAT RX USA LLC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	RISPERIDONE TABLET [STAT RX USA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RISPERIDONE TABLET [STAT RX USA LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	RISPERIDONE TABLET [STAT RX USA LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	RISPERIDONE TABLET [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RISPERIDONE TABLET [STAT RX USA LLC]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	RISPERIDONE TABLET [STAT RX USA LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	RISPERIDONE TABLET [STAT RX USA LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	RISPERIDONE TABLET [STAT RX USA LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	RISPERIDONE TABLET [STAT RX USA LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	RISPERIDONE TABLET [STAT RX USA LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RISPERIDONE TABLET [STAT RX USA LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13668-038	RISPERIDONE TABLET [TORRENT PHARMACEUTICALS LIMITED]	24	Current NDC, Legacy NDC, 4 package rows	20250227_a6347895-5f16-43b4-92a0-b9904ac81937.zip

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
312828	risperiDONE 0.25 MG Oral Tablet	PSN	a6347895-5f16-43b4-92a0-b9904ac81937	25
312829	risperiDONE 0.5 MG Oral Tablet	PSN	a6347895-5f16-43b4-92a0-b9904ac81937	25
312830	risperiDONE 1 MG Oral Tablet	PSN	a6347895-5f16-43b4-92a0-b9904ac81937	25
312831	risperiDONE 2 MG Oral Tablet	PSN	a6347895-5f16-43b4-92a0-b9904ac81937	25
312832	risperiDONE 3 MG Oral Tablet	PSN	a6347895-5f16-43b4-92a0-b9904ac81937	25
314211	risperiDONE 4 MG Oral Tablet	PSN	a6347895-5f16-43b4-92a0-b9904ac81937	25
312828	risperidone 0.25 MG Oral Tablet	SCD	a6347895-5f16-43b4-92a0-b9904ac81937	25
312829	risperidone 0.5 MG Oral Tablet	SCD	a6347895-5f16-43b4-92a0-b9904ac81937	25
312830	risperidone 1 MG Oral Tablet	SCD	a6347895-5f16-43b4-92a0-b9904ac81937	25
312831	risperidone 2 MG Oral Tablet	SCD	a6347895-5f16-43b4-92a0-b9904ac81937	25
312832	risperidone 3 MG Oral Tablet	SCD	a6347895-5f16-43b4-92a0-b9904ac81937	25
314211	risperidone 4 MG Oral Tablet	SCD	a6347895-5f16-43b4-92a0-b9904ac81937	25
312830	risperiDONE 1 MG Oral Tablet	PSN	51f57ffa-69f3-43ef-b4e9-b7d4c016b9a4	17
312831	risperiDONE 2 MG Oral Tablet	PSN	51f57ffa-69f3-43ef-b4e9-b7d4c016b9a4	17
312830	risperidone 1 MG Oral Tablet	SCD	51f57ffa-69f3-43ef-b4e9-b7d4c016b9a4	17
312831	risperidone 2 MG Oral Tablet	SCD	51f57ffa-69f3-43ef-b4e9-b7d4c016b9a4	17
312828	risperiDONE 0.25 MG Oral Tablet	PSN	f0c765e9-edc1-4944-a4e6-91b82a29a8d7	5
312829	risperiDONE 0.5 MG Oral Tablet	PSN	f0c765e9-edc1-4944-a4e6-91b82a29a8d7	5
312830	risperiDONE 1 MG Oral Tablet	PSN	f0c765e9-edc1-4944-a4e6-91b82a29a8d7	5
312831	risperiDONE 2 MG Oral Tablet	PSN	f0c765e9-edc1-4944-a4e6-91b82a29a8d7	5
312828	risperidone 0.25 MG Oral Tablet	SCD	f0c765e9-edc1-4944-a4e6-91b82a29a8d7	5
312829	risperidone 0.5 MG Oral Tablet	SCD	f0c765e9-edc1-4944-a4e6-91b82a29a8d7	5
312830	risperidone 1 MG Oral Tablet	SCD	f0c765e9-edc1-4944-a4e6-91b82a29a8d7	5
312831	risperidone 2 MG Oral Tablet	SCD	f0c765e9-edc1-4944-a4e6-91b82a29a8d7	5
312829	risperiDONE 0.5 MG Oral Tablet	PSN	b7e18194-8d57-473d-904c-bb2e576c132b	3
312831	risperiDONE 2 MG Oral Tablet	PSN	b7e18194-8d57-473d-904c-bb2e576c132b	3
312829	risperidone 0.5 MG Oral Tablet	SCD	b7e18194-8d57-473d-904c-bb2e576c132b	3
312831	risperidone 2 MG Oral Tablet	SCD	b7e18194-8d57-473d-904c-bb2e576c132b	3
312828	risperiDONE 0.25 MG Oral Tablet	PSN	2e8fb017-8754-421a-a76a-c41b8f48070b	1
312829	risperiDONE 0.5 MG Oral Tablet	PSN	2e8fb017-8754-421a-a76a-c41b8f48070b	1
312830	risperiDONE 1 MG Oral Tablet	PSN	2e8fb017-8754-421a-a76a-c41b8f48070b	1
312830	risperiDONE 1 MG Oral Tablet	PSN	dce4437a-bf43-483c-8db2-5eb58fa8a559	1
312831	risperiDONE 2 MG Oral Tablet	PSN	b1174730-7a95-4bf6-a425-a5bc1836a17a	1
312831	risperiDONE 2 MG Oral Tablet	PSN	dce4437a-bf43-483c-8db2-5eb58fa8a559	1
312831	risperiDONE 2 MG Oral Tablet	PSN	2e8fb017-8754-421a-a76a-c41b8f48070b	1
312832	risperiDONE 3 MG Oral Tablet	PSN	dce4437a-bf43-483c-8db2-5eb58fa8a559	1
312832	risperiDONE 3 MG Oral Tablet	PSN	2e8fb017-8754-421a-a76a-c41b8f48070b	1
314211	risperiDONE 4 MG Oral Tablet	PSN	dce4437a-bf43-483c-8db2-5eb58fa8a559	1
312828	risperidone 0.25 MG Oral Tablet	SCD	2e8fb017-8754-421a-a76a-c41b8f48070b	1
312829	risperidone 0.5 MG Oral Tablet	SCD	2e8fb017-8754-421a-a76a-c41b8f48070b	1
312830	risperidone 1 MG Oral Tablet	SCD	dce4437a-bf43-483c-8db2-5eb58fa8a559	1
312830	risperidone 1 MG Oral Tablet	SCD	2e8fb017-8754-421a-a76a-c41b8f48070b	1
312831	risperidone 2 MG Oral Tablet	SCD	2e8fb017-8754-421a-a76a-c41b8f48070b	1
312831	risperidone 2 MG Oral Tablet	SCD	dce4437a-bf43-483c-8db2-5eb58fa8a559	1
312831	risperidone 2 MG Oral Tablet	SCD	b1174730-7a95-4bf6-a425-a5bc1836a17a	1
312832	risperidone 3 MG Oral Tablet	SCD	2e8fb017-8754-421a-a76a-c41b8f48070b	1
312832	risperidone 3 MG Oral Tablet	SCD	dce4437a-bf43-483c-8db2-5eb58fa8a559	1
314211	risperidone 4 MG Oral Tablet	SCD	dce4437a-bf43-483c-8db2-5eb58fa8a559	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
13668-038-01	13668003801	100 TABLET in 1 BOTTLE (13668-038-01)	100 tablet	2009-01-01	0000-00-00	No	No	Current
13668-038-05	13668003805	500 TABLET in 1 BOTTLE (13668-038-05)	500 tablet	2009-01-01	0000-00-00	No	No	Current
13668-038-55	13668003855	4200 TABLET in 1 BOTTLE (13668-038-55)	4200 tablet	2009-01-01	0000-00-00	No	No	Current
13668-038-60	13668003860	60 TABLET in 1 BOTTLE (13668-038-60)	60 tablet	2009-01-01	0000-00-00	No	No	Current
13668-038-74	13668003874	100 TABLET in 1 CARTON (13668-038-74)	100 tablet	2009-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Risperidone	Torrent Pharmaceuticals Limited \| Torrent Pharma, Inc.	2026-03-03	HUMAN PRESCRIPTION DRUG LABEL	25
Risperidone	A-S Medication Solutions	2021-06-14	HUMAN PRESCRIPTION DRUG LABEL	17
Risperidone	H.J. Harkins Company, Inc.	2012-01-19	HUMAN PRESCRIPTION DRUG LABEL	3
RISPERIDONE	STAT Rx USA LLC	2011-10-06	HUMAN PRESCRIPTION DRUG LABEL	1
Risperidone	Rebel Distributors Corp	2010-11-11	HUMAN PRESCRIPTION DRUG LABEL	1
Risperidone	State of Florida DOH Central Pharmacy	2010-05-20	HUMAN PRESCRIPTION DRUG LABEL	1
Risperidone	Physicians Total Care, Inc \| Physicians Total Care, Inc.	2009-10-29	HUMAN PRESCRIPTION DRUG LABEL	5

Risperidone

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#