rocuronium bromide

Generic: rocuronium bromide

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

Drug Facts

Product Profile

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

rocuronium bromide 10 mg/mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-718
Product ID 71288-718_aad39c88-2e2c-49a6-aa13-de852483661f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213453
Listing Expiration 2027-12-31
Marketing Start 2023-05-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288718
Hyphenated Format 71288-718

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 ANDA213453 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL, MULTI-DOSE in 1 CARTON (71288-718-92) / 10 mL in 1 VIAL, MULTI-DOSE (71288-718-91)
source: ndc

Packages (1)

71288-718-92 10 VIAL, MULTI-DOSE in 1 CARTON (71288-718-92) / 10 mL in 1 VIAL, MULTI-DOSE (71288-718-91)

Ingredients (1)

rocuronium bromide (10 mg/mL)

Linked Drug Pages (2)

Rocuronium Bromide ndc-match (0.9) Rocuronium Bromide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "aad39c88-2e2c-49a6-aa13-de852483661f", "openfda": {"unii": ["I65MW4OFHZ"], "rxcui": ["1234995"], "spl_set_id": ["b23aa80e-2af2-4a66-92ed-b1c8863be704"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, MULTI-DOSE in 1 CARTON (71288-718-92)  / 10 mL in 1 VIAL, MULTI-DOSE (71288-718-91)", "package_ndc": "71288-718-92", "marketing_start_date": "20230508"}], "brand_name": "Rocuronium Bromide", "product_id": "71288-718_aad39c88-2e2c-49a6-aa13-de852483661f", "dosage_form": "INJECTION", "pharm_class": ["Neuromuscular Nondepolarizing Blockade [PE]", "Nondepolarizing Neuromuscular Blocker [EPC]"], "product_ndc": "71288-718", "generic_name": "Rocuronium Bromide", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rocuronium Bromide", "active_ingredients": [{"name": "ROCURONIUM BROMIDE", "strength": "10 mg/mL"}], "application_number": "ANDA213453", "marketing_category": "ANDA", "marketing_start_date": "20230508", "listing_expiration_date": "20271231"}