rocuronium bromide

Generic: rocuronium bromide

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rocuronium bromide
Generic Name rocuronium bromide
Labeler gland pharma limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

rocuronium bromide 10 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-364
Product ID 68083-364_f0786673-741a-4016-9528-268128b3b142
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205656
Listing Expiration 2026-12-31
Marketing Start 2018-05-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083364
Hyphenated Format 68083-364

Supplemental Identifiers

RxCUI
1234995
UPC
0368083365011
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 ANDA205656 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL, MULTI-DOSE in 1 CARTON (68083-364-10) / 5 mL in 1 VIAL, MULTI-DOSE (68083-364-01)
source: ndc

Packages (1)

68083-364-10 10 VIAL, MULTI-DOSE in 1 CARTON (68083-364-10) / 5 mL in 1 VIAL, MULTI-DOSE (68083-364-01)

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": "f0786673-741a-4016-9528-268128b3b142", "openfda": {"upc": ["0368083365011"], "unii": ["I65MW4OFHZ"], "rxcui": ["1234995"], "spl_set_id": ["a223a740-dbe8-4d06-8b8b-d9104b694e62"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, MULTI-DOSE in 1 CARTON (68083-364-10)  / 5 mL in 1 VIAL, MULTI-DOSE (68083-364-01)", "package_ndc": "68083-364-10", "marketing_start_date": "20180518"}], "brand_name": "Rocuronium Bromide", "product_id": "68083-364_f0786673-741a-4016-9528-268128b3b142", "dosage_form": "INJECTION", "pharm_class": ["Neuromuscular Nondepolarizing Blockade [PE]", "Nondepolarizing Neuromuscular Blocker [EPC]"], "product_ndc": "68083-364", "generic_name": "Rocuronium Bromide", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rocuronium Bromide", "active_ingredients": [{"name": "ROCURONIUM BROMIDE", "strength": "10 mg/mL"}], "application_number": "ANDA205656", "marketing_category": "ANDA", "marketing_start_date": "20180518", "listing_expiration_date": "20261231"}