MESNEX
- Product NDC
- 0338-1307
- 11-digit product format
- 003381307
- Labeler code
- 0338
- Product ID
- 0338-1307_1553b83c-11d2-41e7-a140-a373a8fc6483
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MESNA
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Baxter Healthcare Company
- 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
Orange Book products#
| 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#
| 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 | 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 | 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.
| 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 | 019884 NDA019884 |
| MESNEX | MESNA | Baxter Healthcare Company | 49fdfbc3-69f8-4706-9d11-bf60e4e7811b | 2018-12-17 | Warnings, Adverse reactions | 019884 NDA019884 |
| MESNA | MESNA | Baxter Healthcare Company | fe1683ef-0569-411e-8188-0499884632ad | 2018-12-17 | Warnings, Adverse reactions | 019884 NDA019884 |
| MESNA | MESNA | Baxter Healthcare Company | a880160b-fa82-453a-a971-29ab897876a7 | 2018-12-17 | Warnings, Adverse reactions | 019884 NDA019884 |
| MESNEX | MESNA | Baxter Healthcare Company | 2e8eebc3-ea75-4c57-bfe1-2c5dc2c37806 | 2018-07-24 | Warnings, Adverse reactions | 019884 NDA019884 0338-1307 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- MESNEX
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MESNA | 100 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| NR7O1405Q9 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2e8eebc3-ea75-4c57-bfe1-2c5dc2c37806 | Available on FDA.report |
DailyMed Product Concepts#
| 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 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0338-1307-05 | MESNEX | 1 in 1 BOX | INJECTION, SOLUTION | 1 | 10 | |
| 0338-1307-10 | MESNEX | 10 mL in 1 VIAL | INJECTION, SOLUTION | 10 | 10 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 204870 | mesna 100 MG/ML Injectable Solution | PSN | 2e8eebc3-ea75-4c57-bfe1-2c5dc2c37806 | 10 |
| 899350 | Mesnex 100 MG/ML Injectable Solution | PSN | 2e8eebc3-ea75-4c57-bfe1-2c5dc2c37806 | 10 |
| 899350 | mesna 100 MG/ML Injectable Solution [Mesnex] | SBD | 2e8eebc3-ea75-4c57-bfe1-2c5dc2c37806 | 10 |
| 204870 | mesna 100 MG/ML Injectable Solution | SCD | 2e8eebc3-ea75-4c57-bfe1-2c5dc2c37806 | 10 |
| 204870 | mesna 1 GM per 10 ML Injectable Solution | SY | 2e8eebc3-ea75-4c57-bfe1-2c5dc2c37806 | 10 |
| 899350 | Mesnex 100 MG/ML Concentrate for Injectable Solution | SY | 2e8eebc3-ea75-4c57-bfe1-2c5dc2c37806 | 10 |
| 899350 | Mesnex 100 MG/ML Injectable Solution | SY | 2e8eebc3-ea75-4c57-bfe1-2c5dc2c37806 | 10 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0338-1307-05 | 00338130705 | 1 VIAL in 1 BOX (0338-1307-05) / 10 mL in 1 VIAL (0338-1307-10) | 1 vial | 2018-07-18 | 0000-00-00 | No | No | Current |
| 0338-1307-10 | 00338130710 | 10 mL in 1 VIAL | 10 ml | Historical |