rocuronium bromide

Generic: rocuronium bromide

Labeler: hf acquisition co llc, dba healthfirst
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rocuronium bromide
Generic Name rocuronium bromide
Labeler hf acquisition co llc, dba healthfirst
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

rocuronium bromide 10 mg/mL

Manufacturer
HF Acquisition Co LLC, DBA HealthFirst

Identifiers & Regulatory

Product NDC 51662-1354
Product ID 51662-1354_100db255-132c-7c4f-e063-6294a90a01fc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078519
Listing Expiration 2026-12-31
Marketing Start 2019-02-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516621354
Hyphenated Format 51662-1354

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 ANDA078519 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 5 mL in 1 VIAL, MULTI-DOSE (51662-1354-1)
source: ndc

Packages (1)

51662-1354-1 5 mL in 1 VIAL, MULTI-DOSE (51662-1354-1)

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": "100db255-132c-7c4f-e063-6294a90a01fc", "openfda": {"unii": ["I65MW4OFHZ"], "rxcui": ["1234995"], "spl_set_id": ["81628de9-e6bf-8f69-e053-2991aa0a6023"], "manufacturer_name": ["HF Acquisition Co LLC, DBA HealthFirst"]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 VIAL, MULTI-DOSE (51662-1354-1)", "package_ndc": "51662-1354-1", "marketing_start_date": "20190208"}], "brand_name": "ROCURONIUM BROMIDE", "product_id": "51662-1354_100db255-132c-7c4f-e063-6294a90a01fc", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Neuromuscular Nondepolarizing Blockade [PE]", "Nondepolarizing Neuromuscular Blocker [EPC]"], "product_ndc": "51662-1354", "generic_name": "ROCURONIUM BROMIDE", "labeler_name": "HF Acquisition Co LLC, DBA HealthFirst", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ROCURONIUM BROMIDE", "active_ingredients": [{"name": "ROCURONIUM BROMIDE", "strength": "10 mg/mL"}], "application_number": "ANDA078519", "marketing_category": "ANDA", "marketing_start_date": "20190208", "listing_expiration_date": "20261231"}