rocuronium bromide

Generic: rocuronium bromide

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rocuronium bromide
Generic Name rocuronium bromide
Labeler mylan institutional llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

rocuronium bromide 10 mg/mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-228
Product ID 67457-228_b65fbcab-781e-4706-a60b-a8eb4aeae0c1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079199
Listing Expiration 2026-12-31
Marketing Start 2012-02-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457228
Hyphenated Format 67457-228

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 ANDA079199 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL, MULTI-DOSE in 1 CARTON (67457-228-05) / 5 mL in 1 VIAL, MULTI-DOSE (67457-228-00)
  • 10 VIAL, MULTI-DOSE in 1 CARTON (67457-228-10) / 10 mL in 1 VIAL, MULTI-DOSE (67457-228-99)
source: ndc

Packages (2)

67457-228-05 10 VIAL, MULTI-DOSE in 1 CARTON (67457-228-05) / 5 mL in 1 VIAL, MULTI-DOSE (67457-228-00) 67457-228-10 10 VIAL, MULTI-DOSE in 1 CARTON (67457-228-10) / 10 mL in 1 VIAL, MULTI-DOSE (67457-228-99)

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": "b65fbcab-781e-4706-a60b-a8eb4aeae0c1", "openfda": {"unii": ["I65MW4OFHZ"], "rxcui": ["1234995"], "spl_set_id": ["f58803b0-f173-4997-b2f8-0f415b94dacf"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, MULTI-DOSE in 1 CARTON (67457-228-05)  / 5 mL in 1 VIAL, MULTI-DOSE (67457-228-00)", "package_ndc": "67457-228-05", "marketing_start_date": "20120206"}, {"sample": false, "description": "10 VIAL, MULTI-DOSE in 1 CARTON (67457-228-10)  / 10 mL in 1 VIAL, MULTI-DOSE (67457-228-99)", "package_ndc": "67457-228-10", "marketing_start_date": "20120206"}], "brand_name": "Rocuronium Bromide", "product_id": "67457-228_b65fbcab-781e-4706-a60b-a8eb4aeae0c1", "dosage_form": "INJECTION", "pharm_class": ["Neuromuscular Nondepolarizing Blockade [PE]", "Nondepolarizing Neuromuscular Blocker [EPC]"], "product_ndc": "67457-228", "generic_name": "rocuronium bromide", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rocuronium Bromide", "active_ingredients": [{"name": "ROCURONIUM BROMIDE", "strength": "10 mg/mL"}], "application_number": "ANDA079199", "marketing_category": "ANDA", "marketing_start_date": "20120206", "listing_expiration_date": "20261231"}