UZEDY

Product NDC: 51759-410
11-digit product format: 517590410
Labeler code: 51759
Product ID: 51759-410_fbc54ee2-4211-4765-a288-75778def0f5a
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N213586-001	UZEDY	50MG/0.14ML (50MG/0.14ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-002	UZEDY	75MG/0.21ML (75MG/0.21ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-003	UZEDY	100MG/0.28ML (100MG/0.28ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-004	UZEDY	125MG/0.35ML (125MG/0.35ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-005	UZEDY	150MG/0.42ML (150MG/0.42ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-006	UZEDY	200MG/0.56ML (200MG/0.56ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-007	UZEDY	250MG/0.7ML (250MG/0.7ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213586-001	UZEDY	50MG/0.14ML (50MG/0.14ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213586-002	UZEDY	75MG/0.21ML (75MG/0.21ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213586-003	UZEDY	100MG/0.28ML (100MG/0.28ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213586-004	UZEDY	125MG/0.35ML (125MG/0.35ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213586-005	UZEDY	150MG/0.42ML (150MG/0.42ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213586-006	UZEDY	200MG/0.56ML (200MG/0.56ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213586-007	UZEDY	250MG/0.7ML (250MG/0.7ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-04-28	`caaa826d4ba7…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 39 · 1,536 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N213586-001	8221778	2027-11-12	U-601	Drug product	2023-05-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-001	8221778	2027-11-12	U-543	Drug product	2023-05-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-001	8741327	2027-11-12	U-543	Drug product	2023-05-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-001	9023897	2033-04-05		Drug product	2023-05-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-001	12128132	2040-09-11	U-601	Drug product	2024-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-001	12128132	2040-09-11	U-543	Drug product	2024-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-001	12383493	2040-09-11	U-601	Drug product	2025-09-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-001	12383493	2040-09-11	U-543	Drug product	2025-09-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-001	12329851	2042-03-17	U-4214		2025-07-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-002	8221778	2027-11-12	U-601	Drug product	2023-05-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-002	8221778	2027-11-12	U-543	Drug product	2023-05-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-002	8741327	2027-11-12	U-543	Drug product	2023-05-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-002	9023897	2033-04-05		Drug product	2023-05-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-002	12128132	2040-09-11	U-601	Drug product	2024-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-002	12128132	2040-09-11	U-543	Drug product	2024-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-002	12383493	2040-09-11	U-601	Drug product	2025-09-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-002	12383493	2040-09-11	U-543	Drug product	2025-09-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-002	12329851	2042-03-17	U-4214		2025-07-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-003	8221778	2027-11-12	U-601	Drug product	2023-05-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-003	8221778	2027-11-12	U-543	Drug product	2023-05-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-003	8741327	2027-11-12	U-543	Drug product	2023-05-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-003	9023897	2033-04-05		Drug product	2023-05-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-003	12128132	2040-09-11	U-601	Drug product	2024-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-003	12128132	2040-09-11	U-543	Drug product	2024-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-003	12383493	2040-09-11	U-601	Drug product	2025-09-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-003	12383493	2040-09-11	U-543	Drug product	2025-09-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-003	12329851	2042-03-17	U-4214		2025-07-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-004	8221778	2027-11-12	U-543	Drug product	2023-05-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-004	8741327	2027-11-12	U-543	Drug product	2023-05-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-004	9023897	2033-04-05		Drug product	2023-05-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-004	12128132	2040-09-11	U-543	Drug product	2024-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-004	12383493	2040-09-11	U-543	Drug product	2025-09-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-004	12329851	2042-03-17	U-4214		2025-07-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-005	8221778	2027-11-12	U-543	Drug product	2023-05-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-005	8741327	2027-11-12	U-543	Drug product	2023-05-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-005	9023897	2033-04-05		Drug product	2023-05-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-005	12128132	2040-09-11	U-543	Drug product	2024-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-005	12383493	2040-09-11	U-543	Drug product	2025-09-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-005	12329851	2042-03-17	U-4214		2025-07-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-006	8221778	2027-11-12	U-543	Drug product	2023-05-03	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 161 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N213586-001	NP	2026-04-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-002	NP	2026-04-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-003	NP	2026-04-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-004	NP	2026-04-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-005	NP	2026-04-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-006	NP	2026-04-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213586-007	NP	2026-04-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213586-001	NP	2026-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213586-002	NP	2026-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213586-003	NP	2026-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213586-004	NP	2026-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213586-005	NP	2026-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213586-006	NP	2026-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213586-007	NP	2026-04-28	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

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

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