rocuronium

Generic: rocuronium bromide

Labeler: phlow corporation
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rocuronium
Generic Name rocuronium bromide
Labeler phlow corporation
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

rocuronium bromide 10 mg/mL

Manufacturer
Phlow Corporation

Identifiers & Regulatory

Product NDC 81565-204
Product ID 81565-204_7297a261-1b67-4281-bd1d-80a366cb446e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078651
Listing Expiration 2026-12-31
Marketing Start 2022-02-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81565204
Hyphenated Format 81565-204

Supplemental Identifiers

RxCUI
1234995
UPC
0381565204011
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 (source: ndc)
Generic Name rocuronium bromide (source: ndc)
Application Number ANDA078651 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 TRAY (81565-204-02) / 5 mL in 1 VIAL (81565-204-01)
source: ndc

Packages (1)

81565-204-02 10 VIAL in 1 TRAY (81565-204-02) / 5 mL in 1 VIAL (81565-204-01)

Ingredients (1)

rocuronium bromide (10 mg/mL)

Linked Drug Pages (1)

Rocuronium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "7297a261-1b67-4281-bd1d-80a366cb446e", "openfda": {"upc": ["0381565204011"], "unii": ["I65MW4OFHZ"], "rxcui": ["1234995"], "spl_set_id": ["ad34ecc7-ff1f-4ee5-a235-e453873d0313"], "manufacturer_name": ["Phlow Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 TRAY (81565-204-02)  / 5 mL in 1 VIAL (81565-204-01)", "package_ndc": "81565-204-02", "marketing_start_date": "20220208"}], "brand_name": "Rocuronium", "product_id": "81565-204_7297a261-1b67-4281-bd1d-80a366cb446e", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Neuromuscular Nondepolarizing Blockade [PE]", "Nondepolarizing Neuromuscular Blocker [EPC]"], "product_ndc": "81565-204", "generic_name": "ROCURONIUM BROMIDE", "labeler_name": "Phlow Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rocuronium", "active_ingredients": [{"name": "ROCURONIUM BROMIDE", "strength": "10 mg/mL"}], "application_number": "ANDA078651", "marketing_category": "ANDA", "marketing_start_date": "20220208", "listing_expiration_date": "20261231"}