MESNEX

Product NDC: 0338-1305
11-digit product format: 003381305
Labeler code: 0338
Product ID: 0338-1305_74c4c92d-675a-47c0-a42d-2d1f6721e4e8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mesna
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Baxter Healthcare Corporation
Application: NDA019884
Marketing category: NDA
Marketing start: 1988-12-30
Substance: MESNA
Active strength: 100 mg/mL
Pharmacologic classes: Cytoprotective Agent [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
N019884-001	MESNEX	MESNA	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N019884-001	AP

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N019884-001	AP	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MESNEX	MESNA	Bamboo US Bidco LCC	1dd69e84-616d-fb77-e063-6394a90af2f4	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019884 application number: NDA019884
MESNEX	MESNA	Baxter Healthcare Company	49fdfbc3-69f8-4706-9d11-bf60e4e7811b	2018-12-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019884 application number: NDA019884 ndc (product): 0338-1305
MESNA	MESNA	Baxter Healthcare Company	fe1683ef-0569-411e-8188-0499884632ad	2018-12-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019884 application number: NDA019884
MESNA	MESNA	Baxter Healthcare Company	a880160b-fa82-453a-a971-29ab897876a7	2018-12-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019884 application number: NDA019884
MESNEX	MESNA	Baxter Healthcare Company	2e8eebc3-ea75-4c57-bfe1-2c5dc2c37806	2018-07-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019884 application number: NDA019884

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MESNA	100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
NR7O1405Q9	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
204870	Internal RxNorm lookup
899350	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
49fdfbc3-69f8-4706-9d11-bf60e4e7811b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d255b108-5509-4278-c140-9ab9db8148b2	Product name	2	20251105
d4a974a1-ae49-8695-229c-b23b6bff9d4b	Product name	3	20180221
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0338-1305-01	MESNEX	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	10	20
0338-1305-01	MESNEX	1 in 1 BOX	INJECTION, SOLUTION	1	20
0338-1305-03	MESNEX	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	10	20
0338-1305-03	MESNEX	10 in 1 BOX	INJECTION, SOLUTION	10	20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0338-1305-01	ML - Milliliter	0338-1305	fadeb022-7613-45b9-b1a5-734f9001cc02	1	2012-07-24
0338-1305-03	ML - Milliliter	0338-1305	1b66bb8f-6cbc-470a-8cce-bef5bb921039	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MESNA	ACTIVE INGREDIENT	NR7O1405Q9	MESNEX (MESNA) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	7
2-MERCAPTOETHANESULFONIC ACID	ACTIVE MOIETY	VHD28S0H7F	MESNEX (MESNA) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	7
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	MESNEX (MESNA) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	7
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	MESNEX (MESNA) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	7
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	MESNEX (MESNA) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0338-1305	MESNEX (MESNA) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	18	Current NDC, Legacy NDC, 4 package rows	20250410_49fdfbc3-69f8-4706-9d11-bf60e4e7811b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NR7O1405Q9	MESNA	19767-45-4	MESNA

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
204870	mesna 100 MG/ML Injectable Solution	PSN	49fdfbc3-69f8-4706-9d11-bf60e4e7811b	20
899350	Mesnex 100 MG/ML Injectable Solution	PSN	49fdfbc3-69f8-4706-9d11-bf60e4e7811b	20
899350	mesna 100 MG/ML Injectable Solution [Mesnex]	SBD	49fdfbc3-69f8-4706-9d11-bf60e4e7811b	20
204870	mesna 100 MG/ML Injectable Solution	SCD	49fdfbc3-69f8-4706-9d11-bf60e4e7811b	20
204870	mesna 1 GM per 10 ML Injectable Solution	SY	49fdfbc3-69f8-4706-9d11-bf60e4e7811b	20
899350	Mesnex 100 MG/ML Concentrate for Injectable Solution	SY	49fdfbc3-69f8-4706-9d11-bf60e4e7811b	20
899350	Mesnex 100 MG/ML Injectable Solution	SY	49fdfbc3-69f8-4706-9d11-bf60e4e7811b	20

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0338-1305-01	00338130501	1 VIAL, MULTI-DOSE in 1 BOX (0338-1305-01) / 10 mL in 1 VIAL, MULTI-DOSE	1988-12-30	0000-00-00	No	No	Current
0338-1305-03	00338130503	10 VIAL, MULTI-DOSE in 1 BOX (0338-1305-03) / 10 mL in 1 VIAL, MULTI-DOSE	1988-12-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MESNEX	Baxter Healthcare Company \| Baxter Healthcare Corporation \| Baxter Deutschland GmbH	2018-12-17	HUMAN PRESCRIPTION DRUG LABEL	20