Erzofri extended-release

Product NDC: 72526-105
11-digit product format: 725260105
Labeler code: 72526
Product ID: 72526-105_4c9a70a9-b1b5-b462-e063-6294a90adefd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: paliperidone palmitate
Dosage form: INJECTION
Route: INTRAMUSCULAR
Labeler: Shandong Luye Pharmaceutical Co., Ltd.
Application: NDA216352
Marketing category: NDA
Marketing start: 2024-12-10
Substance: PALIPERIDONE PALMITATE
Active strength: 39 mg/.25mL
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 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N216352-001	ERZOFRI	PALIPERIDONE PALMITATE	39MG/0.25ML (39MG/0.25ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26
N216352-002	ERZOFRI	PALIPERIDONE PALMITATE	78MG/0.5ML (78MG/0.5ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26
N216352-003	ERZOFRI	PALIPERIDONE PALMITATE	117MG/0.75ML (117MG/0.75ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26
N216352-004	ERZOFRI	PALIPERIDONE PALMITATE	156MG/ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26
N216352-005	ERZOFRI	PALIPERIDONE PALMITATE	234MG/1.5ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26
N216352-006	ERZOFRI	PALIPERIDONE PALMITATE	351MG/2.25ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26

Orange Book patents#

Current patent rows page 1 of 1 · 24 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N216352-001	12128049	2038-10-26	U-3968	2024-10-31
N216352-001	12128049	2038-10-26	U-3969	2024-10-31
N216352-001	11666573	2039-09-24	U-3968	2024-07-30
N216352-001	11666573	2039-09-24	U-3969	2024-07-30
N216352-002	12128049	2038-10-26	U-3968	2024-10-31
N216352-002	12128049	2038-10-26	U-3969	2024-10-31
N216352-002	11666573	2039-09-24	U-3968	2024-07-30
N216352-002	11666573	2039-09-24	U-3969	2024-07-30
N216352-003	12128049	2038-10-26	U-3968	2024-10-31
N216352-003	12128049	2038-10-26	U-3969	2024-10-31
N216352-003	11666573	2039-09-24	U-3968	2024-07-30
N216352-003	11666573	2039-09-24	U-3969	2024-07-30
N216352-004	12128049	2038-10-26	U-3968	2024-10-31
N216352-004	12128049	2038-10-26	U-3969	2024-10-31
N216352-004	11666573	2039-09-24	U-3968	2024-07-30
N216352-004	11666573	2039-09-24	U-3969	2024-07-30
N216352-005	12128049	2038-10-26	U-3968	2024-10-31
N216352-005	12128049	2038-10-26	U-3969	2024-10-31
N216352-005	11666573	2039-09-24	U-3968	2024-07-30
N216352-005	11666573	2039-09-24	U-3969	2024-07-30
N216352-006	12128049	2038-10-26	U-3968	2024-10-31
N216352-006	12128049	2038-10-26	U-3969	2024-10-31
N216352-006	11666573	2039-09-24	U-3968	2024-07-30
N216352-006	11666573	2039-09-24	U-3969	2024-07-30

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 2 · 72 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	N216352-001	ERZOFRI	39MG/0.25ML (39MG/0.25ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216352-002	ERZOFRI	78MG/0.5ML (78MG/0.5ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216352-003	ERZOFRI	117MG/0.75ML (117MG/0.75ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216352-004	ERZOFRI	156MG/ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216352-005	ERZOFRI	234MG/1.5ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216352-006	ERZOFRI	351MG/2.25ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216352-001	ERZOFRI	39MG/0.25ML (39MG/0.25ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216352-002	ERZOFRI	78MG/0.5ML (78MG/0.5ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216352-003	ERZOFRI	117MG/0.75ML (117MG/0.75ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216352-004	ERZOFRI	156MG/ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216352-005	ERZOFRI	234MG/1.5ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216352-006	ERZOFRI	351MG/2.25ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216352-001	ERZOFRI	39MG/0.25ML (39MG/0.25ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216352-002	ERZOFRI	78MG/0.5ML (78MG/0.5ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216352-003	ERZOFRI	117MG/0.75ML (117MG/0.75ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216352-004	ERZOFRI	156MG/ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216352-005	ERZOFRI	234MG/1.5ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216352-006	ERZOFRI	351MG/2.25ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216352-001	ERZOFRI	39MG/0.25ML (39MG/0.25ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216352-002	ERZOFRI	78MG/0.5ML (78MG/0.5ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216352-003	ERZOFRI	117MG/0.75ML (117MG/0.75ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216352-004	ERZOFRI	156MG/ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216352-005	ERZOFRI	234MG/1.5ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216352-006	ERZOFRI	351MG/2.25ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216352-001	ERZOFRI	39MG/0.25ML (39MG/0.25ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216352-002	ERZOFRI	78MG/0.5ML (78MG/0.5ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216352-003	ERZOFRI	117MG/0.75ML (117MG/0.75ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216352-004	ERZOFRI	156MG/ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216352-005	ERZOFRI	234MG/1.5ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216352-006	ERZOFRI	351MG/2.25ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216352-001	ERZOFRI	39MG/0.25ML (39MG/0.25ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216352-002	ERZOFRI	78MG/0.5ML (78MG/0.5ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216352-003	ERZOFRI	117MG/0.75ML (117MG/0.75ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216352-004	ERZOFRI	156MG/ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216352-005	ERZOFRI	234MG/1.5ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216352-006	ERZOFRI	351MG/2.25ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216352-001	ERZOFRI	39MG/0.25ML (39MG/0.25ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216352-002	ERZOFRI	78MG/0.5ML (78MG/0.5ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216352-003	ERZOFRI	117MG/0.75ML (117MG/0.75ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216352-004	ERZOFRI	156MG/ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`2680178bc6a6…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 252 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N216352-001	12128049	2038-10-26	U-3968	2024-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216352-001	12128049	2038-10-26	U-3969	2024-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216352-001	11666573	2039-09-24	U-3968	2024-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216352-001	11666573	2039-09-24	U-3969	2024-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216352-002	12128049	2038-10-26	U-3969	2024-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216352-002	12128049	2038-10-26	U-3968	2024-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216352-002	11666573	2039-09-24	U-3969	2024-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216352-002	11666573	2039-09-24	U-3968	2024-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216352-003	12128049	2038-10-26	U-3969	2024-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216352-003	12128049	2038-10-26	U-3968	2024-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216352-003	11666573	2039-09-24	U-3969	2024-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216352-003	11666573	2039-09-24	U-3968	2024-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216352-004	12128049	2038-10-26	U-3969	2024-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216352-004	12128049	2038-10-26	U-3968	2024-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216352-004	11666573	2039-09-24	U-3969	2024-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216352-004	11666573	2039-09-24	U-3968	2024-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216352-005	12128049	2038-10-26	U-3969	2024-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216352-005	12128049	2038-10-26	U-3968	2024-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216352-005	11666573	2039-09-24	U-3969	2024-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216352-005	11666573	2039-09-24	U-3968	2024-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216352-006	12128049	2038-10-26	U-3969	2024-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216352-006	12128049	2038-10-26	U-3968	2024-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216352-006	11666573	2039-09-24	U-3969	2024-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216352-006	11666573	2039-09-24	U-3968	2024-07-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216352-001	12128049	2038-10-26	U-3968	2024-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216352-001	12128049	2038-10-26	U-3969	2024-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216352-001	11666573	2039-09-24	U-3968	2024-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216352-001	11666573	2039-09-24	U-3969	2024-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216352-002	12128049	2038-10-26	U-3969	2024-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216352-002	12128049	2038-10-26	U-3968	2024-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216352-002	11666573	2039-09-24	U-3969	2024-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216352-002	11666573	2039-09-24	U-3968	2024-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216352-003	12128049	2038-10-26	U-3969	2024-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216352-003	12128049	2038-10-26	U-3968	2024-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216352-003	11666573	2039-09-24	U-3969	2024-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216352-003	11666573	2039-09-24	U-3968	2024-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216352-004	12128049	2038-10-26	U-3969	2024-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216352-004	12128049	2038-10-26	U-3968	2024-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216352-004	11666573	2039-09-24	U-3969	2024-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216352-004	11666573	2039-09-24	U-3968	2024-07-30	`31067a03dcf5…`

Additional Listing Data#

Finished product: Yes
Brand name base: Erzofri extended-release
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PALIPERIDONE PALMITATE	39 mg/.25mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
R8P8USM8FR	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
858048	Internal RxNorm lookup
858052	Internal RxNorm lookup
858054	Internal RxNorm lookup
858056	Internal RxNorm lookup
858073	Internal RxNorm lookup
2699342	Internal RxNorm lookup
2699348	Internal RxNorm lookup
2699350	Internal RxNorm lookup
2699351	Internal RxNorm lookup
2699352	Internal RxNorm lookup
2699353	Internal RxNorm lookup
2699354	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
492bf9dd-868e-421a-92db-8cca8973aac1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3752075e-d817-45ea-9aa1-8dc0301cf2aa	Product name	1	20251114
893dce58-6330-4a9a-ab03-5ffd7148e184	Product name	1	20250311
b6847380-b533-d626-e29e-10b60b2ad451	Product name	9	20250303
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
fd328049-536a-4914-b42e-93bf4d93db24	Product name	1	20220307
0f0756fc-4d63-4f75-afcc-9c5e62a38d69	Product name	2	20220304
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72526-105-11	Erzofri extended-release	1 in 1 KIT	INJECTION	1		7
72526-105-11	Erzofri extended-release	0.25 mL in 1 SYRINGE, GLASS	INJECTION	0.25		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72526-105-11	ML - Milliliter	72526-105	70392675-3b9a-4a84-9534-9a1572c0ea51	1	2024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72526-105	ERZOFRI EXTENDED-RELEASE (PALIPERIDONE PALMITATE) INJECTION [SHANDONG LUYE PHARMACEUTICAL CO., LTD.]	4	Current NDC, 2 package rows	20250321_492bf9dd-868e-421a-92db-8cca8973aac1.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
Erzofri extended-release	PALIPERIDONE PALMITATE	Shandong Luye Pharmaceutical Co., Ltd.	492bf9dd-868e-421a-92db-8cca8973aac1	2026-03-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 216352 application number: NDA216352 ndc (product): 72526-105

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R8P8USM8FR	PALIPERIDONE PALMITATE	199739-10-1	PALIPERIDONE PALMITATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2699350	Erzofri 117 MG in 0.75 ML Prefilled Syringe	PSN	492bf9dd-868e-421a-92db-8cca8973aac1	7
2699351	Erzofri 156 MG in 1 ML Prefilled Syringe	PSN	492bf9dd-868e-421a-92db-8cca8973aac1	7
2699352	Erzofri 234 MG in 1.5 ML Prefilled Syringe	PSN	492bf9dd-868e-421a-92db-8cca8973aac1	7
2699348	Erzofri 351 MG in 2.25 ML Prefilled Syringe	PSN	492bf9dd-868e-421a-92db-8cca8973aac1	7
2699353	Erzofri 39 MG in 0.25 ML Prefilled Syringe	PSN	492bf9dd-868e-421a-92db-8cca8973aac1	7
2699354	Erzofri 78 MG in 0.5 ML Prefilled Syringe	PSN	492bf9dd-868e-421a-92db-8cca8973aac1	7
858056	paliperidone palmitate 117 MG in 0.75 ML Prefilled Syringe	PSN	492bf9dd-868e-421a-92db-8cca8973aac1	7
858054	paliperidone palmitate 156 MG in 1 ML Prefilled Syringe	PSN	492bf9dd-868e-421a-92db-8cca8973aac1	7
858052	paliperidone palmitate 234 MG in 1.5 ML Prefilled Syringe	PSN	492bf9dd-868e-421a-92db-8cca8973aac1	7
2699342	paliperidone palmitate 351 MG in 2.25 ML Prefilled Syringe	PSN	492bf9dd-868e-421a-92db-8cca8973aac1	7
858073	paliperidone palmitate 39 MG in 0.25 ML Prefilled Syringe	PSN	492bf9dd-868e-421a-92db-8cca8973aac1	7
858048	paliperidone palmitate 78 MG in 0.5 ML Prefilled Syringe	PSN	492bf9dd-868e-421a-92db-8cca8973aac1	7
2699353	0.25 ML paliperidone palmitate 156 MG/ML Prefilled Syringe [Erzofri]	SBD	492bf9dd-868e-421a-92db-8cca8973aac1	7
2699354	0.5 ML paliperidone palmitate 156 MG/ML Prefilled Syringe [Erzofri]	SBD	492bf9dd-868e-421a-92db-8cca8973aac1	7
2699350	0.75 ML paliperidone palmitate 156 MG/ML Prefilled Syringe [Erzofri]	SBD	492bf9dd-868e-421a-92db-8cca8973aac1	7
2699351	1 ML paliperidone palmitate 156 MG/ML Prefilled Syringe [Erzofri]	SBD	492bf9dd-868e-421a-92db-8cca8973aac1	7
2699352	1.5 ML paliperidone palmitate 156 MG/ML Prefilled Syringe [Erzofri]	SBD	492bf9dd-868e-421a-92db-8cca8973aac1	7
2699348	2.25 ML paliperidone palmitate 156 MG/ML Prefilled Syringe [Erzofri]	SBD	492bf9dd-868e-421a-92db-8cca8973aac1	7
858073	0.25 ML paliperidone palmitate 156 MG/ML Prefilled Syringe	SCD	492bf9dd-868e-421a-92db-8cca8973aac1	7
858048	0.5 ML paliperidone palmitate 156 MG/ML Prefilled Syringe	SCD	492bf9dd-868e-421a-92db-8cca8973aac1	7
858056	0.75 ML paliperidone palmitate 156 MG/ML Prefilled Syringe	SCD	492bf9dd-868e-421a-92db-8cca8973aac1	7
858054	1 ML paliperidone palmitate 156 MG/ML Prefilled Syringe	SCD	492bf9dd-868e-421a-92db-8cca8973aac1	7
858052	1.5 ML paliperidone palmitate 156 MG/ML Prefilled Syringe	SCD	492bf9dd-868e-421a-92db-8cca8973aac1	7
2699342	2.25 ML paliperidone palmitate 156 MG/ML Prefilled Syringe	SCD	492bf9dd-868e-421a-92db-8cca8973aac1	7
2699350	Erzofri 117 MG per 0.75 ML Extended Release Injectable Suspension in a Prefilled Syringe	SY	492bf9dd-868e-421a-92db-8cca8973aac1	7
2699350	Erzofri 117 MG per 0.75 ML Prefilled Syringe	SY	492bf9dd-868e-421a-92db-8cca8973aac1	7
2699351	Erzofri 156 MG per 1 ML Extended Release Injectable Suspension in a Prefilled Syringe	SY	492bf9dd-868e-421a-92db-8cca8973aac1	7
2699351	Erzofri 156 MG per 1 ML Prefilled Syringe	SY	492bf9dd-868e-421a-92db-8cca8973aac1	7
2699352	Erzofri 234 MG per 1.5 ML Extended Release Injectable Suspension in a Prefilled Syringe	SY	492bf9dd-868e-421a-92db-8cca8973aac1	7
2699352	Erzofri 234 MG per 1.5 ML Prefilled Syringe	SY	492bf9dd-868e-421a-92db-8cca8973aac1	7
2699348	Erzofri 351 MG per 2.25 ML Extended Release Injectable Suspension in a Prefilled Syringe	SY	492bf9dd-868e-421a-92db-8cca8973aac1	7
2699348	Erzofri 351 MG per 2.25 ML Prefilled Syringe	SY	492bf9dd-868e-421a-92db-8cca8973aac1	7
2699353	Erzofri 39 MG per 0.25 ML Extended Release Injectable Suspension in a Prefilled Syringe	SY	492bf9dd-868e-421a-92db-8cca8973aac1	7
2699353	Erzofri 39 MG per 0.25 ML Prefilled Syringe	SY	492bf9dd-868e-421a-92db-8cca8973aac1	7
2699354	Erzofri 78 MG per 0.5 ML Extended Release Injectable Suspension in a Prefilled Syringe	SY	492bf9dd-868e-421a-92db-8cca8973aac1	7
2699354	Erzofri 78 MG per 0.5 ML Prefilled Syringe	SY	492bf9dd-868e-421a-92db-8cca8973aac1	7
858056	paliperidone palmitate 117 MG per 0.75 ML Prefilled Syringe	SY	492bf9dd-868e-421a-92db-8cca8973aac1	7
858054	paliperidone palmitate 156 MG per 1 ML Prefilled Syringe	SY	492bf9dd-868e-421a-92db-8cca8973aac1	7
858052	paliperidone palmitate 234 MG per 1.5 ML Prefilled Syringe	SY	492bf9dd-868e-421a-92db-8cca8973aac1	7
2699342	paliperidone palmitate 351 MG per 2.25 ML Extended Release Injectable Suspension in a Prefilled Syringe	SY	492bf9dd-868e-421a-92db-8cca8973aac1	7
2699342	paliperidone palmitate 351 MG per 2.25 ML Prefilled Syringe	SY	492bf9dd-868e-421a-92db-8cca8973aac1	7
858073	paliperidone palmitate 39 MG per 0.25 ML Prefilled Syringe	SY	492bf9dd-868e-421a-92db-8cca8973aac1	7
858048	paliperidone palmitate 78 MG per 0.5 ML Prefilled Syringe	SY	492bf9dd-868e-421a-92db-8cca8973aac1	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72526-105-11	72526010511	1 SYRINGE, GLASS in 1 KIT (72526-105-11) / .25 mL in 1 SYRINGE, GLASS	2024-12-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Erzofri extended-release	Shandong Luye Pharmaceutical Co., Ltd. \| Interquim, S.A. \| Curia Spain, S.A.U.	2026-03-09	HUMAN PRESCRIPTION DRUG LABEL	7