rocuronium bromide

Generic: rocuronium bromide

Labeler: caplin steriles limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rocuronium bromide
Generic Name rocuronium bromide
Labeler caplin steriles limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

rocuronium bromide 10 mg/mL

Manufacturer
Caplin Steriles Limited

Identifiers & Regulatory

Product NDC 65145-130
Product ID 65145-130_7196a63c-b610-474e-8119-bcb37e909e1e
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 65145130
Hyphenated Format 65145-130

Supplemental Identifiers

RxCUI
1234995
UPC
0365145131010 0365145130013 0365145130105 0365145131102
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 ANDA216234 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL, MULTI-DOSE in 1 CARTON (65145-130-10) / 5 mL in 1 VIAL, MULTI-DOSE (65145-130-01)
source: ndc

Packages (1)

65145-130-10 10 VIAL, MULTI-DOSE in 1 CARTON (65145-130-10) / 5 mL in 1 VIAL, MULTI-DOSE (65145-130-01)

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": "7196a63c-b610-474e-8119-bcb37e909e1e", "openfda": {"upc": ["0365145131010", "0365145130013", "0365145130105", "0365145131102"], "unii": ["I65MW4OFHZ"], "rxcui": ["1234995"], "spl_set_id": ["f1794318-b058-4254-97b7-d4e07126efbb"], "manufacturer_name": ["Caplin Steriles Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, MULTI-DOSE in 1 CARTON (65145-130-10)  / 5 mL in 1 VIAL, MULTI-DOSE (65145-130-01)", "package_ndc": "65145-130-10", "marketing_start_date": "20241003"}], "brand_name": "ROCURONIUM BROMIDE", "product_id": "65145-130_7196a63c-b610-474e-8119-bcb37e909e1e", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Neuromuscular Nondepolarizing Blockade [PE]", "Nondepolarizing Neuromuscular Blocker [EPC]"], "product_ndc": "65145-130", "generic_name": "ROCURONIUM BROMIDE", "labeler_name": "Caplin Steriles Limited", "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"}