Mesna

Product NDC: 25021-201
Requested package NDC: 25021-201-69
11-digit product format: 250210201
Labeler code: 25021
Product ID: 25021-201_b216cb2c-ff72-4b54-9486-404a23092128
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mesna
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Sagent Pharmaceuticals
Application: ANDA090913
Marketing category: ANDA
Marketing start: 2010-12-01
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	25021-201	25021-201-69	D	Discontinued by firm		2026-07-31

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
A090913-001	MESNA	MESNA	100MG/ML	INJECTABLE / INTRAVENOUS	AP		2010-04-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090913-001	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	A090913-001	MESNA	100MG/ML	INJECTABLE / INTRAVENOUS	AP		2010-04-13	`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	A090913-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mesna	MESNA	Sagent Pharmaceuticals	2a2a526f-636b-7920-4261-6c626f612a2a	2025-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090913 application number: ANDA090913 ndc (product): 25021-201

Additional Listing Data#

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

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
204870	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
2a2a526f-636b-7920-4261-6c626f612a2a	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
25021-201-10	Mesna	10 mL in 1 VIAL	INJECTION, SOLUTION	10	10
25021-201-10	Mesna	1 in 1 CARTON	INJECTION, SOLUTION	1	10
25021-201-11	Mesna	10 in 1 CARTON	INJECTION, SOLUTION	10	10
25021-201-11	Mesna	10 mL in 1 VIAL	INJECTION, SOLUTION	10	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
25021-201-10	ML - Milliliter	25021-201	c3d2b98a-6381-46b2-bf8c-54a010d066be	1	2012-07-24
25021-201-11	ML - Milliliter	25021-201	db692fd2-2cf8-4672-bacf-9cfca6aeb719	1	2012-07-24
25021-201-66	ML - Milliliter	25021-201	1f95d4e3-32b1-4917-af9d-8ef38abc5852	1	2013-09-04
25021-201-67	ML - Milliliter	25021-201	17b31798-b9f6-4435-b438-8e95f8c0a32b	1	2013-09-04
25021-201-68	ML - Milliliter	25021-201	aefb662d-537d-44f6-a9d6-437d7681d1d5	1	2013-09-04
25021-201-69	ML - Milliliter	25021-201	7ccdb58d-5872-400e-bfd4-a2ef8b3df9f0	1	2013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
mesna	ACTIVE INGREDIENT	NR7O1405Q9	MESNA INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	4
2-Mercaptoethanesulfonic Acid	ACTIVE MOIETY	VHD28S0H7F	MESNA INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	4
benzyl alcohol	INACTIVE INGREDIENT	LKG8494WBH	MESNA INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	4
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	MESNA INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	4
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	MESNA INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	4
water	INACTIVE INGREDIENT	059QF0KO0R	MESNA INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	4
mesna	ACTIVE INGREDIENT	NR7O1405Q9	MESNA INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	2
2-Mercaptoethanesulfonic Acid	ACTIVE MOIETY	VHD28S0H7F	MESNA INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	2
benzyl alcohol	INACTIVE INGREDIENT	LKG8494WBH	MESNA INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	2
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	MESNA INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	2
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	MESNA INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	2
water	INACTIVE INGREDIENT	059QF0KO0R	MESNA INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
25021-201	MESNA INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	10	Current NDC, Legacy NDC, 4 package rows	20250313_2a2a526f-636b-7920-4261-6c626f612a2a.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	2a2a526f-636b-7920-4261-6c626f612a2a	10
204870	mesna 100 MG/ML Injectable Solution	SCD	2a2a526f-636b-7920-4261-6c626f612a2a	10
204870	mesna 1 GM per 10 ML Injectable Solution	SY	2a2a526f-636b-7920-4261-6c626f612a2a	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
25021-201-69	25021020169	10 VIAL in 1 CARTON (25021-201-69) > 10 mL in 1 VIAL	10 vial	2013-04-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mesna	Sagent Pharmaceuticals	2025-03-02	HUMAN PRESCRIPTION DRUG LABEL	10
Mesna	Sagent Pharmaceuticals	2019-04-01	HUMAN PRESCRIPTION DRUG LABEL	6