rocuronium bromide

Generic: rocuronium bromide

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rocuronium bromide
Generic Name rocuronium bromide
Labeler sagent pharmaceuticals
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

rocuronium bromide 10 mg/mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-687
Product ID 25021-687_1d066c67-eac2-494a-ad10-ba7e9c60b0e9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205656
Listing Expiration 2026-12-31
Marketing Start 2023-10-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25021687
Hyphenated Format 25021-687

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 ANDA205656 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (25021-687-05) / 5 mL in 1 VIAL
  • 10 VIAL in 1 CARTON (25021-687-10) / 10 mL in 1 VIAL
source: ndc

Packages (2)

25021-687-05 10 VIAL in 1 CARTON (25021-687-05) / 5 mL in 1 VIAL 25021-687-10 10 VIAL in 1 CARTON (25021-687-10) / 10 mL in 1 VIAL

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": "1d066c67-eac2-494a-ad10-ba7e9c60b0e9", "openfda": {"unii": ["I65MW4OFHZ"], "rxcui": ["1234995"], "spl_set_id": ["01825411-be08-4402-b101-cb546291c972"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (25021-687-05)  / 5 mL in 1 VIAL", "package_ndc": "25021-687-05", "marketing_start_date": "20231015"}, {"sample": false, "description": "10 VIAL in 1 CARTON (25021-687-10)  / 10 mL in 1 VIAL", "package_ndc": "25021-687-10", "marketing_start_date": "20231015"}], "brand_name": "Rocuronium Bromide", "product_id": "25021-687_1d066c67-eac2-494a-ad10-ba7e9c60b0e9", "dosage_form": "INJECTION", "pharm_class": ["Neuromuscular Nondepolarizing Blockade [PE]", "Nondepolarizing Neuromuscular Blocker [EPC]"], "product_ndc": "25021-687", "generic_name": "Rocuronium Bromide", "labeler_name": "Sagent Pharmaceuticals", "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": "20231015", "listing_expiration_date": "20261231"}