rocuronium bromide

Generic: rocuronium bromide

Labeler: solco healthcare us, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rocuronium bromide
Generic Name rocuronium bromide
Labeler solco healthcare us, llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

rocuronium bromide 50 mg/5mL

Manufacturer
Solco Healthcare US, LLC

Identifiers & Regulatory

Product NDC 43547-530
Product ID 43547-530_e926b7a9-5f03-47c4-a7d0-2780b01a34c5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212668
Listing Expiration 2026-12-31
Marketing Start 2021-07-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43547530
Hyphenated Format 43547-530

Supplemental Identifiers

RxCUI
1234995
UPC
0343547530013 0343547531010
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 ANDA212668 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/5mL
source: ndc
Packaging
  • 10 VIAL, MULTI-DOSE in 1 CARTON (43547-530-10) / 5 mL in 1 VIAL, MULTI-DOSE (43547-530-01)
source: ndc

Packages (1)

43547-530-10 10 VIAL, MULTI-DOSE in 1 CARTON (43547-530-10) / 5 mL in 1 VIAL, MULTI-DOSE (43547-530-01)

Ingredients (1)

rocuronium bromide (50 mg/5mL)

Linked Drug Pages (1)

ROCURONIUM BROMIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "e926b7a9-5f03-47c4-a7d0-2780b01a34c5", "openfda": {"upc": ["0343547530013", "0343547531010"], "unii": ["I65MW4OFHZ"], "rxcui": ["1234995"], "spl_set_id": ["b7fba679-9c2d-4dac-af53-8c1331c966c3"], "manufacturer_name": ["Solco Healthcare US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, MULTI-DOSE in 1 CARTON (43547-530-10)  / 5 mL in 1 VIAL, MULTI-DOSE (43547-530-01)", "package_ndc": "43547-530-10", "marketing_start_date": "20210725"}], "brand_name": "ROCURONIUM BROMIDE", "product_id": "43547-530_e926b7a9-5f03-47c4-a7d0-2780b01a34c5", "dosage_form": "INJECTION", "pharm_class": ["Neuromuscular Nondepolarizing Blockade [PE]", "Nondepolarizing Neuromuscular Blocker [EPC]"], "product_ndc": "43547-530", "generic_name": "rocuronium bromide", "labeler_name": "Solco Healthcare US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ROCURONIUM BROMIDE", "active_ingredients": [{"name": "ROCURONIUM BROMIDE", "strength": "50 mg/5mL"}], "application_number": "ANDA212668", "marketing_category": "ANDA", "marketing_start_date": "20210725", "listing_expiration_date": "20261231"}