regonol

Generic: pyridostigmine bromide

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name regonol
Generic Name pyridostigmine bromide
Labeler sandoz inc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS PARENTERAL
Active Ingredients

pyridostigmine bromide 5 mg/mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-3040
Product ID 0781-3040_eaf2bbb9-562b-0e4e-e053-2a95a90abdea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA017398
Listing Expiration 2026-12-31
Marketing Start 2005-05-10

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07813040
Hyphenated Format 0781-3040

Supplemental Identifiers

RxCUI
903851 903855
UNII
KVI301NA53

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 regonol (source: ndc)
Generic Name pyridostigmine bromide (source: ndc)
Application Number NDA017398 (source: ndc)
Routes
INTRAVENOUS PARENTERAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 10 AMPULE in 1 CARTON (0781-3040-95) / 2 mL in 1 AMPULE (0781-3040-72)
source: ndc

Packages (1)

0781-3040-95 10 AMPULE in 1 CARTON (0781-3040-95) / 2 mL in 1 AMPULE (0781-3040-72)

Ingredients (1)

pyridostigmine bromide (5 mg/mL)

Linked Drug Pages (1)

Regonol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS", "PARENTERAL"], "spl_id": "eaf2bbb9-562b-0e4e-e053-2a95a90abdea", "openfda": {"unii": ["KVI301NA53"], "rxcui": ["903851", "903855"], "spl_set_id": ["208af931-a44e-43bf-a265-8e08534dc55f"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 AMPULE in 1 CARTON (0781-3040-95)  / 2 mL in 1 AMPULE (0781-3040-72)", "package_ndc": "0781-3040-95", "marketing_start_date": "20050510"}], "brand_name": "Regonol", "product_id": "0781-3040_eaf2bbb9-562b-0e4e-e053-2a95a90abdea", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "0781-3040", "generic_name": "Pyridostigmine Bromide", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Regonol", "active_ingredients": [{"name": "PYRIDOSTIGMINE BROMIDE", "strength": "5 mg/mL"}], "application_number": "NDA017398", "marketing_category": "NDA", "marketing_start_date": "20050510", "listing_expiration_date": "20261231"}