rocuronium bromide

Generic: rocuronium bromide

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rocuronium bromide
Generic Name rocuronium bromide
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

rocuronium bromide 10 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9251
Product ID 0143-9251_76957fea-9b26-42a6-ad71-c8752142a08b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204679
Listing Expiration 2027-12-31
Marketing Start 2017-04-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439251
Hyphenated Format 0143-9251

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 ANDA204679 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 BOX (0143-9251-10) / 10 mL in 1 VIAL (0143-9251-01)
source: ndc

Packages (1)

0143-9251-10 10 VIAL in 1 BOX (0143-9251-10) / 10 mL in 1 VIAL (0143-9251-01)

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": "76957fea-9b26-42a6-ad71-c8752142a08b", "openfda": {"unii": ["I65MW4OFHZ"], "rxcui": ["1234995"], "spl_set_id": ["d3a172a5-01ab-47d8-92ac-a8539b1d4dc4"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 BOX (0143-9251-10)  / 10 mL in 1 VIAL (0143-9251-01)", "package_ndc": "0143-9251-10", "marketing_start_date": "20170430"}], "brand_name": "Rocuronium Bromide", "product_id": "0143-9251_76957fea-9b26-42a6-ad71-c8752142a08b", "dosage_form": "INJECTION", "pharm_class": ["Neuromuscular Nondepolarizing Blockade [PE]", "Nondepolarizing Neuromuscular Blocker [EPC]"], "product_ndc": "0143-9251", "generic_name": "Rocuronium Bromide", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rocuronium Bromide", "active_ingredients": [{"name": "ROCURONIUM BROMIDE", "strength": "10 mg/mL"}], "application_number": "ANDA204679", "marketing_category": "ANDA", "marketing_start_date": "20170430", "listing_expiration_date": "20271231"}