rocuronium bromide

Generic: rocuronium bromide

Labeler: baxter healthcare corporation
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rocuronium bromide
Generic Name rocuronium bromide
Labeler baxter healthcare corporation
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

rocuronium bromide 100 mg/10mL

Manufacturer
Baxter Healthcare Corporation

Identifiers & Regulatory

Product NDC 43066-013
Product ID 43066-013_9e0317de-2d78-4fd8-8926-4c7b476f3ed4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091115
Listing Expiration 2026-12-31
Marketing Start 2019-07-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43066013
Hyphenated Format 43066-013

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
  • 100 mg/10mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (43066-013-10) / 10 mL in 1 VIAL
source: ndc

Packages (1)

43066-013-10 10 VIAL in 1 CARTON (43066-013-10) / 10 mL in 1 VIAL

Ingredients (1)

rocuronium bromide (100 mg/10mL)

Linked Drug Pages (1)

Rocuronium Bromide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "9e0317de-2d78-4fd8-8926-4c7b476f3ed4", "openfda": {"unii": ["I65MW4OFHZ"], "rxcui": ["1234995"], "spl_set_id": ["31e15c3f-aefa-4379-b684-7707744fe40d"], "manufacturer_name": ["Baxter Healthcare Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (43066-013-10)  / 10 mL in 1 VIAL", "package_ndc": "43066-013-10", "marketing_start_date": "20190715"}], "brand_name": "Rocuronium Bromide", "product_id": "43066-013_9e0317de-2d78-4fd8-8926-4c7b476f3ed4", "dosage_form": "INJECTION", "pharm_class": ["Neuromuscular Nondepolarizing Blockade [PE]", "Nondepolarizing Neuromuscular Blocker [EPC]"], "product_ndc": "43066-013", "generic_name": "Rocuronium Bromide", "labeler_name": "Baxter Healthcare Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rocuronium Bromide", "active_ingredients": [{"name": "ROCURONIUM BROMIDE", "strength": "100 mg/10mL"}], "application_number": "ANDA091115", "marketing_category": "ANDA", "marketing_start_date": "20190715", "listing_expiration_date": "20261231"}