rocuronium bromide

Generic: rocuronium bromide

Labeler: hospira, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rocuronium bromide
Generic Name rocuronium bromide
Labeler hospira, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

rocuronium bromide 10 mg/mL

Manufacturer
Hospira, Inc.

Identifiers & Regulatory

Product NDC 0409-9558
Product ID 0409-9558_53aa93ba-50da-4a40-ad22-144828245c9c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078519
Listing Expiration 2027-12-31
Marketing Start 2008-12-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04099558
Hyphenated Format 0409-9558

Supplemental Identifiers

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 ANDA078519 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL, MULTI-DOSE in 1 BOX (0409-9558-05) / 5 mL in 1 VIAL, MULTI-DOSE (0409-9558-11)
  • 10 VIAL, MULTI-DOSE in 1 BOX (0409-9558-10) / 10 mL in 1 VIAL, MULTI-DOSE (0409-9558-31)
source: ndc

Packages (2)

0409-9558-05 10 VIAL, MULTI-DOSE in 1 BOX (0409-9558-05) / 5 mL in 1 VIAL, MULTI-DOSE (0409-9558-11) 0409-9558-10 10 VIAL, MULTI-DOSE in 1 BOX (0409-9558-10) / 10 mL in 1 VIAL, MULTI-DOSE (0409-9558-31)

Ingredients (1)

rocuronium bromide (10 mg/mL)

Linked Drug Pages (2)

Rocuronium Bromide ndc-match (0.9) ROCURONIUM BROMIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "53aa93ba-50da-4a40-ad22-144828245c9c", "openfda": {"unii": ["I65MW4OFHZ"], "spl_set_id": ["309aeb1b-8022-4df7-8194-ae6529e3395c"], "manufacturer_name": ["Hospira, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, MULTI-DOSE in 1 BOX (0409-9558-05)  / 5 mL in 1 VIAL, MULTI-DOSE (0409-9558-11)", "package_ndc": "0409-9558-05", "marketing_start_date": "20081201"}, {"sample": false, "description": "10 VIAL, MULTI-DOSE in 1 BOX (0409-9558-10)  / 10 mL in 1 VIAL, MULTI-DOSE (0409-9558-31)", "package_ndc": "0409-9558-10", "marketing_start_date": "20081201"}], "brand_name": "Rocuronium Bromide", "product_id": "0409-9558_53aa93ba-50da-4a40-ad22-144828245c9c", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Neuromuscular Nondepolarizing Blockade [PE]", "Nondepolarizing Neuromuscular Blocker [EPC]"], "product_ndc": "0409-9558", "generic_name": "Rocuronium Bromide", "labeler_name": "Hospira, Inc.", "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": "20081201", "listing_expiration_date": "20271231"}