INLEXZO

Product NDC: 57894-225
Requested package NDC: 57894-225-01
11-digit product format: 578940225
Labeler code: 57894
Product ID: 57894-225_87262294-0e5f-43e8-93cc-093104c9f514
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
2026-10-15 13:18:30	2026-09	N219683-001	INLEXZO	EQ 225MG BASE	SYSTEM / INTRAVESICAL	RLD, RS	2025-09-09	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N219683-001	INLEXZO	EQ 225MG BASE	SYSTEM / INTRAVESICAL	RLD, RS	2025-09-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219683-001	INLEXZO	EQ 225MG BASE	SYSTEM / INTRAVESICAL	RLD, RS	2025-09-09	`caaa826d4ba7…`
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
2026-10-15 13:18:30	2026-09	N219683-001	12403086	2030-06-28		Drug product	2025-10-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219683-001	12576253	2030-12-17		Drug product	2026-04-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219683-001	8679094	2032-04-15		Drug product	2025-10-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219683-001	10729823	2034-08-19		Drug product	2025-10-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219683-001	12447241	2034-08-19		Drug product	2025-11-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219683-001	12636300	2038-11-07	U-4552		2026-06-24	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N219683-001	12403086	2030-06-28		Drug product	2025-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219683-001	12576253	2030-12-17		Drug product	2026-04-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219683-001	8679094	2032-04-15		Drug product	2025-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219683-001	10729823	2034-08-19		Drug product	2025-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219683-001	12447241	2034-08-19		Drug product	2025-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219683-001	12636300	2038-11-07	U-4552		2026-06-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219683-001	12403086	2030-06-28		Drug product	2025-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219683-001	12576253	2030-12-17		Drug product	2026-04-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219683-001	8679094	2032-04-15		Drug product	2025-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219683-001	10729823	2034-08-19		Drug product	2025-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219683-001	12447241	2034-08-19		Drug product	2025-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219683-001	12636300	2038-11-07	U-4552		2026-06-24	`caaa826d4ba7…`
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
2026-10-15 13:18:30	2026-09	N219683-001	NP	2028-09-09	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N219683-001	NP	2028-09-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219683-001	NP	2028-09-09	`caaa826d4ba7…`
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…`

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: INLEXZO
Listing expiration: 2027-12-31

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

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

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. \| SGS India Private Limited	2026-10-26	HUMAN PRESCRIPTION DRUG LABEL	2