rocuronium

Generic: rocuronium bromide

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

Drug Facts

Product Profile

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

rocuronium bromide 10 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-442
Product ID 65219-442_31c4c874-3d24-4c86-a301-ee9faf0b5c00
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA217472
Listing Expiration 2026-12-31
Marketing Start 2023-10-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65219442
Hyphenated Format 65219-442

Supplemental Identifiers

RxCUI
2720024 2720026
UPC
0365219444046 0365219697015 0365219442028 0365219695011
UNII
I65MW4OFHZ

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 rocuronium (source: ndc)
Generic Name rocuronium bromide (source: ndc)
Application Number NDA217472 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 TRAY (65219-442-05) / 5 mL in 1 VIAL (65219-442-02)
source: ndc

Packages (1)

65219-442-05 10 VIAL in 1 TRAY (65219-442-05) / 5 mL in 1 VIAL (65219-442-02)

Ingredients (1)

rocuronium bromide (10 mg/mL)

Linked Drug Pages (1)

Rocuronium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "31c4c874-3d24-4c86-a301-ee9faf0b5c00", "openfda": {"upc": ["0365219444046", "0365219697015", "0365219442028", "0365219695011"], "unii": ["I65MW4OFHZ"], "rxcui": ["2720024", "2720026"], "spl_set_id": ["9a622308-7bda-4ca0-9de5-d6b3b4be3384"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 TRAY (65219-442-05)  / 5 mL in 1 VIAL (65219-442-02)", "package_ndc": "65219-442-05", "marketing_start_date": "20231011"}], "brand_name": "Rocuronium", "product_id": "65219-442_31c4c874-3d24-4c86-a301-ee9faf0b5c00", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Neuromuscular Nondepolarizing Blockade [PE]", "Nondepolarizing Neuromuscular Blocker [EPC]"], "product_ndc": "65219-442", "generic_name": "ROCURONIUM BROMIDE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rocuronium", "active_ingredients": [{"name": "ROCURONIUM BROMIDE", "strength": "10 mg/mL"}], "application_number": "NDA217472", "marketing_category": "NDA", "marketing_start_date": "20231011", "listing_expiration_date": "20261231"}