rocuronium bromide

Generic: rocuronium bromide

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rocuronium bromide
Generic Name rocuronium bromide
Labeler eugia us llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

rocuronium bromide 50 mg/5mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-225
Product ID 55150-225_30f618bf-fbbd-4489-acbb-204e8ed78dca
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206206
Listing Expiration 2026-12-31
Marketing Start 2017-04-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150225
Hyphenated Format 55150-225

Supplemental Identifiers

RxCUI
1234995
UPC
0355150226108
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 bromide (source: ndc)
Generic Name rocuronium bromide (source: ndc)
Application Number ANDA206206 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/5mL
source: ndc
Packaging
  • 10 VIAL, MULTI-DOSE in 1 CARTON (55150-225-05) / 5 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

55150-225-05 10 VIAL, MULTI-DOSE in 1 CARTON (55150-225-05) / 5 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

rocuronium bromide (50 mg/5mL)

Linked Drug Pages (1)

Rocuronium Bromide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "30f618bf-fbbd-4489-acbb-204e8ed78dca", "openfda": {"upc": ["0355150226108"], "unii": ["I65MW4OFHZ"], "rxcui": ["1234995"], "spl_set_id": ["116385ea-69fc-4f44-b463-6210291032df"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, MULTI-DOSE in 1 CARTON (55150-225-05)  / 5 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "55150-225-05", "marketing_start_date": "20170412"}], "brand_name": "Rocuronium Bromide", "product_id": "55150-225_30f618bf-fbbd-4489-acbb-204e8ed78dca", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Neuromuscular Nondepolarizing Blockade [PE]", "Nondepolarizing Neuromuscular Blocker [EPC]"], "product_ndc": "55150-225", "generic_name": "Rocuronium Bromide", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rocuronium Bromide", "active_ingredients": [{"name": "ROCURONIUM BROMIDE", "strength": "50 mg/5mL"}], "application_number": "ANDA206206", "marketing_category": "ANDA", "marketing_start_date": "20170412", "listing_expiration_date": "20261231"}