rocuronium

Generic: rocuronium

Labeler: piramal critical care inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rocuronium
Generic Name rocuronium
Labeler piramal critical care inc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

rocuronium bromide 100 mg/10mL

Manufacturer
Piramal Critical Care Inc

Identifiers & Regulatory

Product NDC 66794-229
Product ID 66794-229_3f9e12e4-d3c5-fba6-e063-6294a90a7fd6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210437
Listing Expiration 2026-12-31
Marketing Start 2020-07-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66794229
Hyphenated Format 66794-229

Supplemental Identifiers

RxCUI
1234995
UPC
0366794228021
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 (source: ndc)
Generic Name rocuronium (source: ndc)
Application Number ANDA210437 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/10mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (66794-229-41) / 10 mL in 1 VIAL (66794-229-02)
source: ndc

Packages (1)

Ingredients (1)

rocuronium bromide (100 mg/10mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "3f9e12e4-d3c5-fba6-e063-6294a90a7fd6", "openfda": {"upc": ["0366794228021"], "unii": ["I65MW4OFHZ"], "rxcui": ["1234995"], "spl_set_id": ["98255b70-51f9-8d16-e053-2995a90a8f97"], "manufacturer_name": ["Piramal Critical Care Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (66794-229-41)  / 10 mL in 1 VIAL (66794-229-02)", "package_ndc": "66794-229-41", "marketing_start_date": "20200720"}], "brand_name": "Rocuronium", "product_id": "66794-229_3f9e12e4-d3c5-fba6-e063-6294a90a7fd6", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Neuromuscular Nondepolarizing Blockade [PE]", "Nondepolarizing Neuromuscular Blocker [EPC]"], "product_ndc": "66794-229", "generic_name": "Rocuronium", "labeler_name": "Piramal Critical Care Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rocuronium", "active_ingredients": [{"name": "ROCURONIUM BROMIDE", "strength": "100 mg/10mL"}], "application_number": "ANDA210437", "marketing_category": "ANDA", "marketing_start_date": "20200720", "listing_expiration_date": "20261231"}