mesna

Generic: mesna injection

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mesna
Generic Name mesna injection
Labeler gland pharma limited
Dosage Form SOLUTION
Routes
INTRAVENOUS
Active Ingredients

mesna 100 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-161
Product ID 68083-161_b61d560c-02fd-4ae7-a6f7-fa7edb0a0d3f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206992
Listing Expiration 2026-12-31
Marketing Start 2017-12-20

Pharmacologic Class

Classes
cytoprotective agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083161
Hyphenated Format 68083-161

Supplemental Identifiers

RxCUI
204870
UPC
0368083161019
UNII
NR7O1405Q9

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name mesna (source: ndc)
Generic Name mesna injection (source: ndc)
Application Number ANDA206992 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (68083-161-01) / 10 mL in 1 VIAL, MULTI-DOSE
  • 10 VIAL, MULTI-DOSE in 1 CARTON (68083-161-10) / 10 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (2)

68083-161-01 1 VIAL, MULTI-DOSE in 1 CARTON (68083-161-01) / 10 mL in 1 VIAL, MULTI-DOSE 68083-161-10 10 VIAL, MULTI-DOSE in 1 CARTON (68083-161-10) / 10 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

mesna (100 mg/mL)

Linked Drug Pages (1)

Mesna ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "b61d560c-02fd-4ae7-a6f7-fa7edb0a0d3f", "openfda": {"upc": ["0368083161019"], "unii": ["NR7O1405Q9"], "rxcui": ["204870"], "spl_set_id": ["a7af968c-05cf-4438-94ba-96a2baf9c367"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (68083-161-01)  / 10 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "68083-161-01", "marketing_start_date": "20171220"}, {"sample": false, "description": "10 VIAL, MULTI-DOSE in 1 CARTON (68083-161-10)  / 10 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "68083-161-10", "marketing_start_date": "20171220"}], "brand_name": "Mesna", "product_id": "68083-161_b61d560c-02fd-4ae7-a6f7-fa7edb0a0d3f", "dosage_form": "SOLUTION", "pharm_class": ["Cytoprotective Agent [EPC]"], "product_ndc": "68083-161", "generic_name": "Mesna Injection", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mesna", "active_ingredients": [{"name": "MESNA", "strength": "100 mg/mL"}], "application_number": "ANDA206992", "marketing_category": "ANDA", "marketing_start_date": "20171220", "listing_expiration_date": "20261231"}