rocuronium bromide

Generic: rocuronium bromide

Labeler: xgen pharmaceuticals djb, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rocuronium bromide
Generic Name rocuronium bromide
Labeler xgen pharmaceuticals djb, inc.
Dosage Form SOLUTION
Routes
INTRAVENOUS
Active Ingredients

rocuronium bromide 10 mg/mL

Manufacturer
XGen Pharmaceuticals DJB, Inc.

Identifiers & Regulatory

Product NDC 39822-4200
Product ID 39822-4200_eedcfb07-4e23-3152-e053-2995a90a6e6a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091115
Listing Expiration 2026-12-31
Marketing Start 2012-12-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 398224200
Hyphenated Format 39822-4200

Supplemental Identifiers

RxCUI
1234995
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 ANDA091115 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (39822-4200-2) / 5 mL in 1 VIAL (39822-4200-1)
  • 10 VIAL in 1 CARTON (39822-4200-6) / 10 mL in 1 VIAL (39822-4200-5)
source: ndc

Packages (2)

39822-4200-2 10 VIAL in 1 CARTON (39822-4200-2) / 5 mL in 1 VIAL (39822-4200-1) 39822-4200-6 10 VIAL in 1 CARTON (39822-4200-6) / 10 mL in 1 VIAL (39822-4200-5)

Ingredients (1)

rocuronium bromide (10 mg/mL)

Linked Drug Pages (1)

rocuronium bromide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "eedcfb07-4e23-3152-e053-2995a90a6e6a", "openfda": {"unii": ["I65MW4OFHZ"], "rxcui": ["1234995"], "spl_set_id": ["b73f192c-2912-4ec3-9b4f-05a58d9b35ba"], "manufacturer_name": ["XGen Pharmaceuticals DJB, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (39822-4200-2)  / 5 mL in 1 VIAL (39822-4200-1)", "package_ndc": "39822-4200-2", "marketing_start_date": "20121201"}, {"sample": false, "description": "10 VIAL in 1 CARTON (39822-4200-6)  / 10 mL in 1 VIAL (39822-4200-5)", "package_ndc": "39822-4200-6", "marketing_start_date": "20121201"}], "brand_name": "rocuronium bromide", "product_id": "39822-4200_eedcfb07-4e23-3152-e053-2995a90a6e6a", "dosage_form": "SOLUTION", "pharm_class": ["Neuromuscular Nondepolarizing Blockade [PE]", "Nondepolarizing Neuromuscular Blocker [EPC]"], "product_ndc": "39822-4200", "generic_name": "rocuronium bromide", "labeler_name": "XGen Pharmaceuticals DJB, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "rocuronium bromide", "active_ingredients": [{"name": "ROCURONIUM BROMIDE", "strength": "10 mg/mL"}], "application_number": "ANDA091115", "marketing_category": "ANDA", "marketing_start_date": "20121201", "listing_expiration_date": "20261231"}