UZEDY

Product NDC: 51759-410
11-digit product format: 517590410
Labeler code: 51759
Product ID: 51759-410_b2a4d0bf-6512-4755-8225-ce2716bca07b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: risperidone
Dosage form: INJECTION, SUSPENSION, EXTENDED RELEASE
Route: SUBCUTANEOUS
Labeler: Teva Pharmaceuticals USA, Inc.
Application: NDA213586
Marketing category: NDA
Marketing start: 2023-05-01
Substance: RISPERIDONE
Active strength: 75 mg/.21mL
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: UZEDY
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RISPERIDONE	75 mg/.21mL

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	L6UH7ZF8HC
Rxcui	2636033, 2636039, 2636041, 2636042, 2636043, 2636044, 2636045, 2636046, 2636047, 2636048, 2636049, 2636050, 2636051, 2636052

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
51759-410-10	UZEDY	1 in 1 CARTON	INJECTION, SUSPENSION, EXTENDED	1	7
51759-410-10	UZEDY	0.21 mL in 1 SYRINGE, GLASS	INJECTION, SUSPENSION, EXTENDED	0.21	7
51759-410-11	UZEDY	1 in 1 CARTON	INJECTION, SUSPENSION, EXTENDED	1	7
51759-410-11	UZEDY	0.21 mL in 1 SYRINGE, GLASS	INJECTION, SUSPENSION, EXTENDED	0.21	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51759-410-10	ML - Milliliter	51759-410	009ba1b1-d6d2-4efa-a4d0-9bd374c85f2e	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51759-410	UZEDY (RISPERIDONE) INJECTION, SUSPENSION, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA, INC.]	6	Current NDC, 4 package rows	20250126_734eb776-4be0-4808-834b-0d8b0f9e021e.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
2636033	risperiDONE 100 MG in 0.28 ML Prefilled Syringe	PSN	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636041	risperiDONE 125 MG in 0.35 ML Prefilled Syringe	PSN	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636043	risperiDONE 150 MG in 0.42 ML Prefilled Syringe	PSN	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636045	risperiDONE 200 MG in 0.56 ML Prefilled Syringe	PSN	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636047	risperiDONE 250 MG in 0.7 ML Prefilled Syringe	PSN	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636049	risperiDONE 50 MG in 0.14 ML Prefilled Syringe	PSN	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636051	risperiDONE 75 MG in 0.21 ML Prefilled Syringe	PSN	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636039	UZEDY 100 MG in 0.28 ML Prefilled Syringe	PSN	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636042	UZEDY 125 MG in 0.35 ML Prefilled Syringe	PSN	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636044	UZEDY 150 MG in 0.42 ML Prefilled Syringe	PSN	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636046	UZEDY 200 MG in 0.56 ML Prefilled Syringe	PSN	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636048	UZEDY 250 MG in 0.7 ML Prefilled Syringe	PSN	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636050	UZEDY 50 MG in 0.14 ML Prefilled Syringe	PSN	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636052	UZEDY 75 MG in 0.21 ML Prefilled Syringe	PSN	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636050	0.14 ML risperidone 357 MG/ML Prefilled Syringe [Uzedy]	SBD	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636052	0.21 ML risperidone 357 MG/ML Prefilled Syringe [Uzedy]	SBD	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636039	0.28 ML risperidone 357 MG/ML Prefilled Syringe [Uzedy]	SBD	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636042	0.35 ML risperidone 357 MG/ML Prefilled Syringe [Uzedy]	SBD	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636044	0.42 ML risperidone 357 MG/ML Prefilled Syringe [Uzedy]	SBD	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636046	0.56 ML risperidone 357 MG/ML Prefilled Syringe [Uzedy]	SBD	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636048	0.7 ML risperidone 357 MG/ML Prefilled Syringe [Uzedy]	SBD	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636049	0.14 ML risperidone 357 MG/ML Prefilled Syringe	SCD	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636051	0.21 ML risperidone 357 MG/ML Prefilled Syringe	SCD	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636033	0.28 ML risperidone 357 MG/ML Prefilled Syringe	SCD	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636041	0.35 ML risperidone 357 MG/ML Prefilled Syringe	SCD	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636043	0.42 ML risperidone 357 MG/ML Prefilled Syringe	SCD	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636045	0.56 ML risperidone 357 MG/ML Prefilled Syringe	SCD	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636047	0.7 ML risperidone 357 MG/ML Prefilled Syringe	SCD	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636050	0.14 ML Uzedy 357 MG/ML Prefilled Syringe	SY	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636052	0.21 ML Uzedy 357 MG/ML Prefilled Syringe	SY	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636039	0.28 ML Uzedy 357 MG/ML Prefilled Syringe	SY	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636042	0.35 ML Uzedy 357 MG/ML Prefilled Syringe	SY	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636044	0.42 ML Uzedy 357 MG/ML Prefilled Syringe	SY	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636046	0.56 ML Uzedy 357 MG/ML Prefilled Syringe	SY	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636048	0.7 ML Uzedy 357 MG/ML Prefilled Syringe	SY	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636033	risperidone 100 MG per 0.28 ML Prefilled Syringe	SY	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636041	risperidone 125 MG per 0.35 ML Prefilled Syringe	SY	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636043	risperidone 150 MG per 0.42 ML Prefilled Syringe	SY	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636045	risperidone 200 MG per 0.56 ML Prefilled Syringe	SY	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636047	risperidone 250 MG per 0.7 ML Prefilled Syringe	SY	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636049	risperidone 50 MG per 0.14 ML Prefilled Syringe	SY	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636051	risperidone 75 MG per 0.21 ML Prefilled Syringe	SY	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636039	Uzedy 100 MG per 0.28 ML Prefilled Syringe	SY	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636042	Uzedy 125 MG per 0.35 ML Prefilled Syringe	SY	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636044	Uzedy 150 MG per 0.42 ML Prefilled Syringe	SY	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636046	Uzedy 200 MG per 0.56 ML Prefilled Syringe	SY	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636048	Uzedy 250 MG per 0.7 ML Prefilled Syringe	SY	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636050	Uzedy 50 MG per 0.14 ML Prefilled Syringe	SY	734eb776-4be0-4808-834b-0d8b0f9e021e	7
2636052	Uzedy 75 MG per 0.21 ML Prefilled Syringe	SY	734eb776-4be0-4808-834b-0d8b0f9e021e	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
51759-410-10	51759041010	1 SYRINGE, GLASS in 1 CARTON (51759-410-10) / .21 mL in 1 SYRINGE, GLASS	2023-05-01	No	No	Current
51759-410-11	51759041011	1 SYRINGE, GLASS in 1 CARTON (51759-410-11) / .21 mL in 1 SYRINGE, GLASS	2023-05-01	Yes	No	Current

UZEDY

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#