cisatracurium besylate

Generic: cisatracurium besylate

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cisatracurium besylate
Generic Name cisatracurium besylate
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

cisatracurium besylate 2 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9397
Product ID 0143-9397_cae2e417-a5d5-447b-a5ce-383f776b6d5e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203079
Listing Expiration 2026-12-31
Marketing Start 2025-03-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439397
Hyphenated Format 0143-9397

Supplemental Identifiers

RxCUI
199211
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 ANDA203079 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (0143-9397-10) / 10 mL in 1 VIAL (0143-9397-01)
source: ndc

Packages (1)

0143-9397-10 10 VIAL in 1 CARTON (0143-9397-10) / 10 mL in 1 VIAL (0143-9397-01)

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": "cae2e417-a5d5-447b-a5ce-383f776b6d5e", "openfda": {"unii": ["80YS8O1MBS"], "rxcui": ["199211"], "spl_set_id": ["46c815f6-7a3d-43a3-b470-3377b126ba09"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (0143-9397-10)  / 10 mL in 1 VIAL (0143-9397-01)", "package_ndc": "0143-9397-10", "marketing_start_date": "20250317"}], "brand_name": "Cisatracurium Besylate", "product_id": "0143-9397_cae2e417-a5d5-447b-a5ce-383f776b6d5e", "dosage_form": "INJECTION", "pharm_class": ["Neuromuscular Nondepolarizing Blockade [PE]", "Nondepolarizing Neuromuscular Blocker [EPC]"], "product_ndc": "0143-9397", "generic_name": "Cisatracurium Besylate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cisatracurium Besylate", "active_ingredients": [{"name": "CISATRACURIUM BESYLATE", "strength": "2 mg/mL"}], "application_number": "ANDA203079", "marketing_category": "ANDA", "marketing_start_date": "20250317", "listing_expiration_date": "20261231"}