rocuronium bromide

Generic: rocuronium bromide

Labeler: steriscience specialties private limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rocuronium bromide
Generic Name rocuronium bromide
Labeler steriscience specialties private limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

rocuronium bromide 50 mg/5mL

Manufacturer
STERISCIENCE SPECIALTIES PRIVATE LIMITED

Identifiers & Regulatory

Product NDC 82449-001
Product ID 82449-001_77cc97bc-4ea2-414f-bbf7-8eaaca4c1eae
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217092
Listing Expiration 2026-12-31
Marketing Start 2024-11-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82449001
Hyphenated Format 82449-001

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 ANDA217092 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/5mL
source: ndc
Packaging
  • 10 VIAL, MULTI-DOSE in 1 CARTON (82449-001-02) / 5 mL in 1 VIAL, MULTI-DOSE (82449-001-01)
source: ndc

Packages (1)

82449-001-02 10 VIAL, MULTI-DOSE in 1 CARTON (82449-001-02) / 5 mL in 1 VIAL, MULTI-DOSE (82449-001-01)

Ingredients (1)

rocuronium bromide (50 mg/5mL)

Linked Drug Pages (1)

Rocuronium Bromide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "77cc97bc-4ea2-414f-bbf7-8eaaca4c1eae", "openfda": {"unii": ["I65MW4OFHZ"], "rxcui": ["1234995"], "spl_set_id": ["b894c436-ea67-407e-a801-f334a0c0c2d9"], "manufacturer_name": ["STERISCIENCE SPECIALTIES PRIVATE LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, MULTI-DOSE in 1 CARTON (82449-001-02)  / 5 mL in 1 VIAL, MULTI-DOSE (82449-001-01)", "package_ndc": "82449-001-02", "marketing_start_date": "20241130"}], "brand_name": "Rocuronium Bromide", "product_id": "82449-001_77cc97bc-4ea2-414f-bbf7-8eaaca4c1eae", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Neuromuscular Nondepolarizing Blockade [PE]", "Nondepolarizing Neuromuscular Blocker [EPC]"], "product_ndc": "82449-001", "generic_name": "Rocuronium Bromide", "labeler_name": "STERISCIENCE SPECIALTIES PRIVATE LIMITED", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rocuronium Bromide", "active_ingredients": [{"name": "ROCURONIUM BROMIDE", "strength": "50 mg/5mL"}], "application_number": "ANDA217092", "marketing_category": "ANDA", "marketing_start_date": "20241130", "listing_expiration_date": "20261231"}