cisatracurium

Generic: cisatracurium besylate

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cisatracurium
Generic Name cisatracurium besylate
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

cisatracurium besylate 2 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-417
Product ID 63323-417_0431da49-a804-457c-a823-66d8862db3f2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203183
Listing Expiration 2026-12-31
Marketing Start 2015-02-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323417
Hyphenated Format 63323-417

Supplemental Identifiers

RxCUI
199211 199212 1730194
UPC
0363323418014 0363323416010 0363323417017
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 (source: ndc)
Generic Name cisatracurium besylate (source: ndc)
Application Number ANDA203183 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (63323-417-10) / 10 mL in 1 VIAL (63323-417-01)
source: ndc

Packages (1)

Ingredients (1)

cisatracurium besylate (2 mg/mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "0431da49-a804-457c-a823-66d8862db3f2", "openfda": {"upc": ["0363323418014", "0363323416010", "0363323417017"], "unii": ["80YS8O1MBS"], "rxcui": ["199211", "199212", "1730194"], "spl_set_id": ["f78a07e2-0d3b-4460-b29e-8c10c90afbda"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (63323-417-10)  / 10 mL in 1 VIAL (63323-417-01)", "package_ndc": "63323-417-10", "marketing_start_date": "20150226"}], "brand_name": "Cisatracurium", "product_id": "63323-417_0431da49-a804-457c-a823-66d8862db3f2", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Neuromuscular Nondepolarizing Blockade [PE]", "Nondepolarizing Neuromuscular Blocker [EPC]"], "product_ndc": "63323-417", "generic_name": "CISATRACURIUM BESYLATE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cisatracurium", "active_ingredients": [{"name": "CISATRACURIUM BESYLATE", "strength": "2 mg/mL"}], "application_number": "ANDA203183", "marketing_category": "ANDA", "marketing_start_date": "20150226", "listing_expiration_date": "20261231"}