rocuronium bromide

Generic: rocuronium bromide

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

rocuronium bromide 10 mg/mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-3220
Product ID 0781-3220_eaf32464-7950-434a-e053-2a95a90aa2dc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079195
Listing Expiration 2026-12-31
Marketing Start 2008-12-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07813220
Hyphenated Format 0781-3220

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 ANDA079195 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL, MULTI-DOSE in 1 CARTON (0781-3220-92) / 10 mL in 1 VIAL, MULTI-DOSE (0781-3220-70)
  • 10 VIAL, MULTI-DOSE in 1 CARTON (0781-3220-95) / 5 mL in 1 VIAL, MULTI-DOSE (0781-3220-75)
source: ndc

Packages (2)

0781-3220-92 10 VIAL, MULTI-DOSE in 1 CARTON (0781-3220-92) / 10 mL in 1 VIAL, MULTI-DOSE (0781-3220-70) 0781-3220-95 10 VIAL, MULTI-DOSE in 1 CARTON (0781-3220-95) / 5 mL in 1 VIAL, MULTI-DOSE (0781-3220-75)

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": "eaf32464-7950-434a-e053-2a95a90aa2dc", "openfda": {"unii": ["I65MW4OFHZ"], "rxcui": ["1234995"], "spl_set_id": ["cb28d869-6510-4402-9462-f6bb25fa0fa8"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, MULTI-DOSE in 1 CARTON (0781-3220-92)  / 10 mL in 1 VIAL, MULTI-DOSE (0781-3220-70)", "package_ndc": "0781-3220-92", "marketing_start_date": "20081205"}, {"sample": false, "description": "10 VIAL, MULTI-DOSE in 1 CARTON (0781-3220-95)  / 5 mL in 1 VIAL, MULTI-DOSE (0781-3220-75)", "package_ndc": "0781-3220-95", "marketing_start_date": "20081205"}], "brand_name": "Rocuronium Bromide", "product_id": "0781-3220_eaf32464-7950-434a-e053-2a95a90aa2dc", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Neuromuscular Nondepolarizing Blockade [PE]", "Nondepolarizing Neuromuscular Blocker [EPC]"], "product_ndc": "0781-3220", "generic_name": "Rocuronium Bromide", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rocuronium Bromide", "active_ingredients": [{"name": "ROCURONIUM BROMIDE", "strength": "10 mg/mL"}], "application_number": "ANDA079195", "marketing_category": "ANDA", "marketing_start_date": "20081205", "listing_expiration_date": "20261231"}