cisatracurium besylate

Generic: cisatracurium besylate

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

Drug Facts

Product Profile

Brand Name cisatracurium besylate
Generic Name cisatracurium besylate
Labeler gland pharma limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

cisatracurium besylate 2 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-488
Product ID 68083-488_773f0b75-fafa-439a-b4a3-ca4d2d65eabd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215516
Listing Expiration 2026-12-31
Marketing Start 2025-03-19

Pharmacologic Class

Classes
neuromuscular nondepolarizing blockade [pe] nondepolarizing neuromuscular blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083488
Hyphenated Format 68083-488

Supplemental Identifiers

RxCUI
199211 199212 1730194
UNII
80YS8O1MBS

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 cisatracurium besylate (source: ndc)
Generic Name cisatracurium besylate (source: ndc)
Application Number ANDA215516 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (68083-488-01) / 10 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

68083-488-01 1 VIAL, MULTI-DOSE in 1 CARTON (68083-488-01) / 10 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

cisatracurium besylate (2 mg/mL)

Linked Drug Pages (1)

Cisatracurium besylate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "773f0b75-fafa-439a-b4a3-ca4d2d65eabd", "openfda": {"unii": ["80YS8O1MBS"], "rxcui": ["199211", "199212", "1730194"], "spl_set_id": ["0bacc37a-5e7f-4f05-9206-56fc8041c1ad"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (68083-488-01)  / 10 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "68083-488-01", "marketing_start_date": "20250319"}], "brand_name": "Cisatracurium besylate", "product_id": "68083-488_773f0b75-fafa-439a-b4a3-ca4d2d65eabd", "dosage_form": "INJECTION", "pharm_class": ["Neuromuscular Nondepolarizing Blockade [PE]", "Nondepolarizing Neuromuscular Blocker [EPC]"], "product_ndc": "68083-488", "generic_name": "Cisatracurium besylate", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cisatracurium besylate", "active_ingredients": [{"name": "CISATRACURIUM BESYLATE", "strength": "2 mg/mL"}], "application_number": "ANDA215516", "marketing_category": "ANDA", "marketing_start_date": "20250319", "listing_expiration_date": "20261231"}