MESNEX

Product NDC: 83703-559
11-digit product format: 837030559
Labeler code: 83703
Product ID: 83703-559_4597547b-01bd-48fd-e063-6294a90afad8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mesna
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Bamboo US Bidco LCC
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 42.

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.

Product history page 1 of 2 · 42 observed 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
2026-08-18 06:07:40	2026-07	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019884-001	MESNEX	100MG/ML	INJECTABLE / INTRAVENOUS	AP	RLD, RS	1988-12-30	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N019884-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019884-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019884-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019884-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019884-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019884-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019884-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019884-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019884-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019884-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019884-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019884-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019884-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019884-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019884-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019884-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019884-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019884-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019884-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019884-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019884-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019884-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019884-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019884-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019884-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019884-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019884-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019884-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019884-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019884-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019884-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019884-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019884-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019884-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019884-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019884-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019884-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019884-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019884-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019884-001	AP	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: MESNEX
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 · 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
1dd69e84-616d-fb77-e063-6394a90af2f4	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
83703-559-01	MESNEX	1 in 1 BOX	INJECTION, SOLUTION	1	2
83703-559-01	MESNEX	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	10	2
83703-559-03	MESNEX	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	10	2
83703-559-03	MESNEX	10 in 1 BOX	INJECTION, SOLUTION	10	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83703-559	MESNEX (MESNA) INJECTION, SOLUTION [BAMBOO US BIDCO LCC]	1	Current NDC, 4 package rows	20240723_1dd69e84-616d-fb77-e063-6394a90af2f4.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 · 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 ndc (product): 83703-559
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
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

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	1dd69e84-616d-fb77-e063-6394a90af2f4	2
899350	Mesnex 100 MG/ML Injectable Solution	PSN	1dd69e84-616d-fb77-e063-6394a90af2f4	2
899350	mesna 100 MG/ML Injectable Solution [Mesnex]	SBD	1dd69e84-616d-fb77-e063-6394a90af2f4	2
204870	mesna 100 MG/ML Injectable Solution	SCD	1dd69e84-616d-fb77-e063-6394a90af2f4	2
204870	mesna 1 GM per 10 ML Injectable Solution	SY	1dd69e84-616d-fb77-e063-6394a90af2f4	2
899350	Mesnex 100 MG/ML Concentrate for Injectable Solution	SY	1dd69e84-616d-fb77-e063-6394a90af2f4	2
899350	Mesnex 100 MG/ML Injectable Solution	SY	1dd69e84-616d-fb77-e063-6394a90af2f4	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
83703-559-01	83703055901	1 VIAL, MULTI-DOSE in 1 BOX (83703-559-01) / 10 mL in 1 VIAL, MULTI-DOSE	1988-12-30	No	No	Current
83703-559-03	83703055903	10 VIAL, MULTI-DOSE in 1 BOX (83703-559-03) / 10 mL in 1 VIAL, MULTI-DOSE	1988-12-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MESNEX	Bamboo US Bidco LCC \| Baxter Healthcare Corporation \| Baxter Deutschland GmBH \| Simtra Deutschland GmbH	2025-12-10	HUMAN PRESCRIPTION DRUG LABEL	2