UZEDY

Product NDC: 51759-305
11-digit product format: 517590305
Labeler code: 51759
Product ID: 51759-305_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: 50 mg/.14mL
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 1.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N213586-001	UZEDY	RISPERIDONE	50MG/0.14ML (50MG/0.14ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28
N213586-002	UZEDY	RISPERIDONE	75MG/0.21ML (75MG/0.21ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28
N213586-003	UZEDY	RISPERIDONE	100MG/0.28ML (100MG/0.28ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28
N213586-004	UZEDY	RISPERIDONE	125MG/0.35ML (125MG/0.35ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28
N213586-005	UZEDY	RISPERIDONE	150MG/0.42ML (150MG/0.42ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28
N213586-006	UZEDY	RISPERIDONE	200MG/0.56ML (200MG/0.56ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28
N213586-007	UZEDY	RISPERIDONE	250MG/0.7ML (250MG/0.7ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28

Orange Book patents#

Current patent rows page 1 of 1 · 51 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213586-001	8221778	2027-11-12	U-543	Drug product	2023-05-03
N213586-001	8221778	2027-11-12	U-601	Drug product	2023-05-03
N213586-001	8741327	2027-11-12	U-543	Drug product	2023-05-03
N213586-001	9023897	2033-04-05		Drug product	2023-05-03
N213586-001	12128132	2040-09-11	U-543	Drug product	2024-11-18
N213586-001	12128132	2040-09-11	U-601	Drug product	2024-11-18
N213586-001	12383493	2040-09-11	U-543	Drug product	2025-09-08
N213586-001	12383493	2040-09-11	U-601	Drug product	2025-09-08
N213586-001	12329851	2042-03-17	U-4214		2025-07-14
N213586-002	8221778	2027-11-12	U-543	Drug product	2023-05-03
N213586-002	8221778	2027-11-12	U-601	Drug product	2023-05-03
N213586-002	8741327	2027-11-12	U-543	Drug product	2023-05-03
N213586-002	9023897	2033-04-05		Drug product	2023-05-03
N213586-002	12128132	2040-09-11	U-543	Drug product	2024-11-18
N213586-002	12128132	2040-09-11	U-601	Drug product	2024-11-18
N213586-002	12383493	2040-09-11	U-543	Drug product	2025-09-08
N213586-002	12383493	2040-09-11	U-601	Drug product	2025-09-08
N213586-002	12329851	2042-03-17	U-4214		2025-07-14
N213586-003	8221778	2027-11-12	U-543	Drug product	2023-05-03
N213586-003	8221778	2027-11-12	U-601	Drug product	2023-05-03
N213586-003	8741327	2027-11-12	U-543	Drug product	2023-05-03
N213586-003	9023897	2033-04-05		Drug product	2023-05-03
N213586-003	12128132	2040-09-11	U-543	Drug product	2024-11-18
N213586-003	12128132	2040-09-11	U-601	Drug product	2024-11-18
N213586-003	12383493	2040-09-11	U-543	Drug product	2025-09-08
N213586-003	12383493	2040-09-11	U-601	Drug product	2025-09-08
N213586-003	12329851	2042-03-17	U-4214		2025-07-14
N213586-004	8221778	2027-11-12	U-543	Drug product	2023-05-03
N213586-004	8741327	2027-11-12	U-543	Drug product	2023-05-03
N213586-004	9023897	2033-04-05		Drug product	2023-05-03
N213586-004	12128132	2040-09-11	U-543	Drug product	2024-11-18
N213586-004	12383493	2040-09-11	U-543	Drug product	2025-09-08
N213586-004	12329851	2042-03-17	U-4214		2025-07-14
N213586-005	8221778	2027-11-12	U-543	Drug product	2023-05-03
N213586-005	8741327	2027-11-12	U-543	Drug product	2023-05-03
N213586-005	9023897	2033-04-05		Drug product	2023-05-03
N213586-005	12128132	2040-09-11	U-543	Drug product	2024-11-18
N213586-005	12383493	2040-09-11	U-543	Drug product	2025-09-08
N213586-005	12329851	2042-03-17	U-4214		2025-07-14
N213586-006	8221778	2027-11-12	U-543	Drug product	2023-05-03
N213586-006	8741327	2027-11-12	U-543	Drug product	2023-05-03
N213586-006	9023897	2033-04-05		Drug product	2023-05-03
N213586-006	12128132	2040-09-11	U-543	Drug product	2024-11-18
N213586-006	12383493	2040-09-11	U-543	Drug product	2025-09-08
N213586-006	12329851	2042-03-17	U-4214		2025-07-14
N213586-007	8221778	2027-11-12	U-543	Drug product	2023-05-03
N213586-007	8741327	2027-11-12	U-543	Drug product	2023-05-03
N213586-007	9023897	2033-04-05		Drug product	2023-05-03
N213586-007	12128132	2040-09-11	U-543	Drug product	2024-11-18
N213586-007	12383493	2040-09-11	U-543	Drug product	2025-09-08
N213586-007	12329851	2042-03-17	U-4214		2025-07-14

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 7 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N213586-001	NP	2026-04-28
N213586-002	NP	2026-04-28
N213586-003	NP	2026-04-28
N213586-004	NP	2026-04-28
N213586-005	NP	2026-04-28
N213586-006	NP	2026-04-28
N213586-007	NP	2026-04-28

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 4 · 154 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N213586-001	UZEDY	50MG/0.14ML (50MG/0.14ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-002	UZEDY	75MG/0.21ML (75MG/0.21ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-003	UZEDY	100MG/0.28ML (100MG/0.28ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-004	UZEDY	125MG/0.35ML (125MG/0.35ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-005	UZEDY	150MG/0.42ML (150MG/0.42ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-006	UZEDY	200MG/0.56ML (200MG/0.56ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-007	UZEDY	250MG/0.7ML (250MG/0.7ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213586-001	UZEDY	50MG/0.14ML (50MG/0.14ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213586-002	UZEDY	75MG/0.21ML (75MG/0.21ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213586-003	UZEDY	100MG/0.28ML (100MG/0.28ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213586-004	UZEDY	125MG/0.35ML (125MG/0.35ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213586-005	UZEDY	150MG/0.42ML (150MG/0.42ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213586-006	UZEDY	200MG/0.56ML (200MG/0.56ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213586-007	UZEDY	250MG/0.7ML (250MG/0.7ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213586-001	UZEDY	50MG/0.14ML (50MG/0.14ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213586-002	UZEDY	75MG/0.21ML (75MG/0.21ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213586-003	UZEDY	100MG/0.28ML (100MG/0.28ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213586-004	UZEDY	125MG/0.35ML (125MG/0.35ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213586-005	UZEDY	150MG/0.42ML (150MG/0.42ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213586-006	UZEDY	200MG/0.56ML (200MG/0.56ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213586-007	UZEDY	250MG/0.7ML (250MG/0.7ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213586-001	UZEDY	50MG/0.14ML (50MG/0.14ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213586-002	UZEDY	75MG/0.21ML (75MG/0.21ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213586-003	UZEDY	100MG/0.28ML (100MG/0.28ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213586-004	UZEDY	125MG/0.35ML (125MG/0.35ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213586-005	UZEDY	150MG/0.42ML (150MG/0.42ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213586-006	UZEDY	200MG/0.56ML (200MG/0.56ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213586-007	UZEDY	250MG/0.7ML (250MG/0.7ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213586-001	UZEDY	50MG/0.14ML (50MG/0.14ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213586-002	UZEDY	75MG/0.21ML (75MG/0.21ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213586-003	UZEDY	100MG/0.28ML (100MG/0.28ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213586-004	UZEDY	125MG/0.35ML (125MG/0.35ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213586-005	UZEDY	150MG/0.42ML (150MG/0.42ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213586-006	UZEDY	200MG/0.56ML (200MG/0.56ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213586-007	UZEDY	250MG/0.7ML (250MG/0.7ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213586-001	UZEDY	50MG/0.14ML (50MG/0.14ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213586-002	UZEDY	75MG/0.21ML (75MG/0.21ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213586-003	UZEDY	100MG/0.28ML (100MG/0.28ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213586-004	UZEDY	125MG/0.35ML (125MG/0.35ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213586-005	UZEDY	150MG/0.42ML (150MG/0.42ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`03ed91905a0d…`

Observed Orange Book patent history#

Patent history page 1 of 36 · 1,434 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N213586-001	8221778	2027-11-12	U-601	Drug product	2023-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-001	8221778	2027-11-12	U-543	Drug product	2023-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-001	8741327	2027-11-12	U-543	Drug product	2023-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-001	9023897	2033-04-05		Drug product	2023-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-001	12128132	2040-09-11	U-601	Drug product	2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-001	12128132	2040-09-11	U-543	Drug product	2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-001	12383493	2040-09-11	U-601	Drug product	2025-09-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-001	12383493	2040-09-11	U-543	Drug product	2025-09-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-001	12329851	2042-03-17	U-4214		2025-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-002	8221778	2027-11-12	U-601	Drug product	2023-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-002	8221778	2027-11-12	U-543	Drug product	2023-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-002	8741327	2027-11-12	U-543	Drug product	2023-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-002	9023897	2033-04-05		Drug product	2023-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-002	12128132	2040-09-11	U-601	Drug product	2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-002	12128132	2040-09-11	U-543	Drug product	2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-002	12383493	2040-09-11	U-601	Drug product	2025-09-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-002	12383493	2040-09-11	U-543	Drug product	2025-09-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-002	12329851	2042-03-17	U-4214		2025-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-003	8221778	2027-11-12	U-601	Drug product	2023-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-003	8221778	2027-11-12	U-543	Drug product	2023-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-003	8741327	2027-11-12	U-543	Drug product	2023-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-003	9023897	2033-04-05		Drug product	2023-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-003	12128132	2040-09-11	U-601	Drug product	2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-003	12128132	2040-09-11	U-543	Drug product	2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-003	12383493	2040-09-11	U-601	Drug product	2025-09-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-003	12383493	2040-09-11	U-543	Drug product	2025-09-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-003	12329851	2042-03-17	U-4214		2025-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-004	8221778	2027-11-12	U-543	Drug product	2023-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-004	8741327	2027-11-12	U-543	Drug product	2023-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-004	9023897	2033-04-05		Drug product	2023-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-004	12128132	2040-09-11	U-543	Drug product	2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-004	12383493	2040-09-11	U-543	Drug product	2025-09-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-004	12329851	2042-03-17	U-4214		2025-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-005	8221778	2027-11-12	U-543	Drug product	2023-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-005	8741327	2027-11-12	U-543	Drug product	2023-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-005	9023897	2033-04-05		Drug product	2023-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-005	12128132	2040-09-11	U-543	Drug product	2024-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-005	12383493	2040-09-11	U-543	Drug product	2025-09-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-005	12329851	2042-03-17	U-4214		2025-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-006	8221778	2027-11-12	U-543	Drug product	2023-05-03	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 147 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N213586-001	NP	2026-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-002	NP	2026-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-003	NP	2026-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-004	NP	2026-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-005	NP	2026-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-006	NP	2026-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213586-007	NP	2026-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213586-001	NP	2026-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213586-002	NP	2026-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213586-003	NP	2026-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213586-004	NP	2026-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213586-005	NP	2026-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213586-006	NP	2026-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213586-007	NP	2026-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213586-001	NP	2026-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213586-002	NP	2026-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213586-003	NP	2026-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213586-004	NP	2026-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213586-005	NP	2026-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213586-006	NP	2026-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213586-007	NP	2026-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213586-001	NP	2026-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213586-002	NP	2026-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213586-003	NP	2026-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213586-004	NP	2026-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213586-005	NP	2026-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213586-006	NP	2026-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213586-007	NP	2026-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213586-001	NP	2026-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213586-002	NP	2026-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213586-003	NP	2026-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213586-004	NP	2026-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213586-005	NP	2026-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213586-006	NP	2026-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213586-007	NP	2026-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213586-001	NP	2026-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213586-002	NP	2026-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213586-003	NP	2026-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213586-004	NP	2026-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213586-005	NP	2026-04-28	`03ed91905a0d…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RISPERIDONE	50 mg/.14mL

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 · 14 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2636033	Internal RxNorm lookup
2636039	Internal RxNorm lookup
2636041	Internal RxNorm lookup
2636042	Internal RxNorm lookup
2636043	Internal RxNorm lookup
2636044	Internal RxNorm lookup
2636045	Internal RxNorm lookup
2636046	Internal RxNorm lookup
2636047	Internal RxNorm lookup
2636048	Internal RxNorm lookup
2636049	Internal RxNorm lookup
2636050	Internal RxNorm lookup
2636051	Internal RxNorm lookup
2636052	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
734eb776-4be0-4808-834b-0d8b0f9e021e	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51759-305-10	UZEDY	1 in 1 CARTON	INJECTION, SUSPENSION, EXTENDED	1	7
51759-305-10	UZEDY	0.14 mL in 1 SYRINGE, GLASS	INJECTION, SUSPENSION, EXTENDED	0.14	7
51759-305-11	UZEDY	0.14 mL in 1 SYRINGE, GLASS	INJECTION, SUSPENSION, EXTENDED	0.14	7
51759-305-11	UZEDY	1 in 1 CARTON	INJECTION, SUSPENSION, EXTENDED	1	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51759-305-10	ML - Milliliter	51759-305	ef48c12c-6173-4a8a-81e8-4d6c8af02a3f	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51759-305	UZEDY (RISPERIDONE) INJECTION, SUSPENSION, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA, INC.]	6	Current NDC, 4 package rows	20250126_734eb776-4be0-4808-834b-0d8b0f9e021e.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
UZEDY	RISPERIDONE	Teva Pharmaceuticals USA, Inc.	734eb776-4be0-4808-834b-0d8b0f9e021e	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 213586 application number: NDA213586 ndc (product): 51759-305

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
51759-305-10	51759030510	1 SYRINGE, GLASS in 1 CARTON (51759-305-10) / .14 mL in 1 SYRINGE, GLASS	2023-05-01	No	No	Current
51759-305-11	51759030511	1 SYRINGE, GLASS in 1 CARTON (51759-305-11) / .14 mL in 1 SYRINGE, GLASS	2023-05-01	Yes	No	Current