rocuronium

Generic: rocuronium bromide

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA 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 63323-426
Product ID 63323-426_3f4d5e11-2c14-4406-8954-04dba2fc65ff
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078651
Listing Expiration 2026-12-31
Marketing Start 2009-12-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323426
Hyphenated Format 63323-426

Supplemental Identifiers

RxCUI
1234995
UPC
0363323426125
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 ANDA078651 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 TRAY (63323-426-15) / 5 mL in 1 VIAL (63323-426-12)
source: ndc

Packages (1)

63323-426-15 10 VIAL in 1 TRAY (63323-426-15) / 5 mL in 1 VIAL (63323-426-12)

Ingredients (1)

rocuronium bromide (10 mg/mL)

Linked Drug Pages (2)

Rocuronium ndc-match (0.9) Rocuronium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "3f4d5e11-2c14-4406-8954-04dba2fc65ff", "openfda": {"upc": ["0363323426125"], "unii": ["I65MW4OFHZ"], "rxcui": ["1234995"], "spl_set_id": ["fb9524b2-c353-4747-8954-7ca2529eabb2"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 TRAY (63323-426-15)  / 5 mL in 1 VIAL (63323-426-12)", "package_ndc": "63323-426-15", "marketing_start_date": "20091213"}], "brand_name": "Rocuronium", "product_id": "63323-426_3f4d5e11-2c14-4406-8954-04dba2fc65ff", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Neuromuscular Nondepolarizing Blockade [PE]", "Nondepolarizing Neuromuscular Blocker [EPC]"], "product_ndc": "63323-426", "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": "ANDA078651", "marketing_category": "ANDA", "marketing_start_date": "20091213", "listing_expiration_date": "20261231"}