rocuronium bromide

Generic: rocuronium bromide

Labeler: propharma distribution
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rocuronium bromide
Generic Name rocuronium bromide
Labeler propharma distribution
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

rocuronium bromide 10 mg/mL

Manufacturer
ProPharma Distribution

Identifiers & Regulatory

Product NDC 84549-131
Product ID 84549-131_42da65ee-2403-7b51-e063-6394a90a46b7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216234
Listing Expiration 2026-12-31
Marketing Start 2024-10-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 84549131
Hyphenated Format 84549-131

Supplemental Identifiers

RxCUI
1234995
UNII
I65MW4OFHZ

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 ANDA216234 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 mL in 1 VIAL, MULTI-DOSE (84549-131-10)
source: ndc

Packages (1)

84549-131-10 10 mL in 1 VIAL, MULTI-DOSE (84549-131-10)

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": "42da65ee-2403-7b51-e063-6394a90a46b7", "openfda": {"unii": ["I65MW4OFHZ"], "rxcui": ["1234995"], "spl_set_id": ["42da65ee-2402-7b51-e063-6394a90a46b7"], "manufacturer_name": ["ProPharma Distribution"]}, "finished": true, "packaging": [{"sample": false, "description": "10 mL in 1 VIAL, MULTI-DOSE (84549-131-10)", "package_ndc": "84549-131-10", "marketing_start_date": "20251010"}], "brand_name": "ROCURONIUM BROMIDE", "product_id": "84549-131_42da65ee-2403-7b51-e063-6394a90a46b7", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Neuromuscular Nondepolarizing Blockade [PE]", "Nondepolarizing Neuromuscular Blocker [EPC]"], "product_ndc": "84549-131", "generic_name": "ROCURONIUM BROMIDE", "labeler_name": "ProPharma Distribution", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ROCURONIUM BROMIDE", "active_ingredients": [{"name": "ROCURONIUM BROMIDE", "strength": "10 mg/mL"}], "application_number": "ANDA216234", "marketing_category": "ANDA", "marketing_start_date": "20241003", "listing_expiration_date": "20261231"}