INLEXZO

Product NDC: 57894-225
11-digit product format: 578940225
Labeler code: 57894
Product ID: 57894-225_3e9075cb-001f-40f0-e063-6394a90aee94
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: gemcitabine intravesical
Dosage form: SYSTEM
Route: INTRAVESICAL
Labeler: Janssen Biotech, Inc
Application: NDA219683
Marketing category: NDA
Marketing start: 2025-09-14
Substance: GEMCITABINE
Active strength: 225 mg/1
Pharmacologic classes: Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N219683-001	INLEXZO	GEMCITABINE HYDROCHLORIDE	EQ 225MG BASE	SYSTEM / INTRAVESICAL		RLD, RS	2025-09-09

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N219683-001	12403086	2030-06-28		Drug product	2025-10-08
N219683-001	12576253	2030-12-17		Drug product	2026-04-07
N219683-001	8679094	2032-04-15		Drug product	2025-10-08
N219683-001	10729823	2034-08-19		Drug product	2025-10-08
N219683-001	12447241	2034-08-19		Drug product	2025-11-17
N219683-001	12636300	2038-11-07	U-4552		2026-06-24

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219683-001	NP	2028-09-09

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.

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	N219683-001	INLEXZO	EQ 225MG BASE	SYSTEM / INTRAVESICAL	RLD, RS	2025-09-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219683-001	INLEXZO	EQ 225MG BASE	SYSTEM / INTRAVESICAL	RLD, RS	2025-09-09	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219683-001	INLEXZO	EQ 225MG BASE	SYSTEM / INTRAVESICAL	RLD, RS	2025-09-09	`a50c72e98297…`

Observed Orange Book patent history#

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	N219683-001	12403086	2030-06-28		Drug product	2025-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219683-001	8679094	2032-04-15		Drug product	2025-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219683-001	10729823	2034-08-19		Drug product	2025-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219683-001	12447241	2034-08-19		Drug product	2025-11-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219683-001	12403086	2030-06-28		Drug product	2025-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219683-001	8679094	2032-04-15		Drug product	2025-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219683-001	10729823	2034-08-19		Drug product	2025-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219683-001	12447241	2034-08-19		Drug product	2025-11-17	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219683-001	12403086	2030-06-28		Drug product	2025-10-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219683-001	12576253	2030-12-17		Drug product	2026-04-07	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219683-001	8679094	2032-04-15		Drug product	2025-10-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219683-001	10729823	2034-08-19		Drug product	2025-10-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219683-001	12447241	2034-08-19		Drug product	2025-11-17	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219683-001	12636300	2038-11-07	U-4552		2026-06-24	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N219683-001	NP	2028-09-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219683-001	NP	2028-09-09	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219683-001	NP	2028-09-09	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GEMCITABINE	225 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
B76N6SBZ8R	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2723386	Internal RxNorm lookup
2723391	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
3aef8dbc-34d0-4150-89f0-3b16cf0fbfdb	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a2b7d477-0e35-4772-8a9d-99c71e3e210b	Product name	2	20190614
4c31c9b8-06d5-4f83-9eb7-cd946af7067a	Product name	5	20190612
a12a1c0c-65f2-45a0-8bf0-7dfc55c750b6	Product name	1	20180829
d2980057-8cff-4896-979e-b4c394974cfd	Product name	1	20170829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57894-225-01	INLEXZO	1 in 1 BOX	SYSTEM	1		1
57894-225-99	INLEXZO	1 in 1 BOX	SYSTEM	1		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57894-225-01	EA - Each	57894-225	19384e57-18dc-4e6b-b76b-85579872c9d1	1	2025-10-14

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
INLEXZO	GEMCITABINE INTRAVESICAL	Janssen Biotech, Inc	3aef8dbc-34d0-4150-89f0-3b16cf0fbfdb	2025-09-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 219683 application number: NDA219683 ndc (product): 57894-225

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
B76N6SBZ8R	GEMCITABINE	95058-81-4	GEMCITABINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2723386	gemcitabine 225 MG Intravesical System	PSN	3aef8dbc-34d0-4150-89f0-3b16cf0fbfdb	1
2723391	inlexzo 225 MG Intravesical System	PSN	3aef8dbc-34d0-4150-89f0-3b16cf0fbfdb	1
2723391	gemcitabine 225 MG Drug Implant [Inlexzo]	SBD	3aef8dbc-34d0-4150-89f0-3b16cf0fbfdb	1
2723386	gemcitabine 225 MG Drug Implant	SCD	3aef8dbc-34d0-4150-89f0-3b16cf0fbfdb	1
2723386	gemcitabine 225 MG Intravesical System	SY	3aef8dbc-34d0-4150-89f0-3b16cf0fbfdb	1
2723391	Inlexzo 225 MG Intravesical System	SY	3aef8dbc-34d0-4150-89f0-3b16cf0fbfdb	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
57894-225-01	57894022501	1 SYSTEM in 1 BOX (57894-225-01)	1 system	2025-09-14	No	No	Current
57894-225-99	57894022599	1 SYSTEM in 1 BOX (57894-225-99)	1 system	2025-09-14	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
INLEXZO	Janssen Biotech, Inc \| Shilpa Pharma Lifesciences Limited \| Sterigenics U.S., LLC \| Eurofins Biolab Srl \| Janssen Pharmaceutica NV \| Johnson & Johnson Private Limited \| Alcami Carolinas Corporation \| AndersonBrecon Inc. \| BSP Pharmaceuticals SpA \| Corden Pharma GmbH \| Catalent CTS, LLC \| Labor LS SE & Co. KG \| Isomedix Operations, Inc. A STERIS Company \| STERIS Laboratories \| NACS, Inc.	2025-09-11	HUMAN PRESCRIPTION DRUG LABEL	1