NDC 0781-3040

Regonol

Pyridostigmine Bromide

Regonol is a Intravenous; Parenteral Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Pyridostigmine Bromide.

• Product ID: 0781-3040_4caa505d-21b9-4601-9221-79aa94f70c7f
• NDC: 0781-3040
• Product Type: Human Prescription Drug
• Proprietary Name: Regonol
• Generic Name: Pyridostigmine Bromide
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS; PARENTERAL
• Marketing Start Date: 2005-05-10
• Marketing Category: NDA / NDA
• Application Number: NDA017398
• Labeler Name: Sandoz Inc
• Substance Name: PYRIDOSTIGMINE BROMIDE
• Active Ingredient Strength: 5 mg/mL
• Pharm Classes: Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0781-3040-95

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

• Marketing Start Date: 2005-05-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0781-3040-72 [00781304072]

Regonol INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA017398
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2005-05-10

NDC 0781-3040-95 [00781304095]

Regonol INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA017398
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2005-05-10

Drug Details

Active Ingredients

Ingredient	Strength
PYRIDOSTIGMINE BROMIDE	5 mg/mL

OpenFDA Data

• SPL SET ID: 208af931-a44e-43bf-a265-8e08534dc55f
• Manufacturer:
  • Sandoz Inc
• UNII:
  • KVI301NA53
• RxNorm Concept Unique ID - RxCUI:
  • 903851
  • 903855

Pharmacological Class

• Cholinesterase Inhibitor [EPC]
• Cholinesterase Inhibitors [MoA]

NDC Crossover Matching brand name "Regonol" or generic name "Pyridostigmine Bromide"

NDC	Brand Name	Generic Name
0781-3040	Regonol	Pyridostigmine Bromide
0187-3010	Mestinon	pyridostigmine bromide
0187-3012	Mestinon	pyridostigmine bromide
0187-3013	Mestinon	pyridostigmine bromide
13811-716	Pryidostigmine Bromide	Pyridostigmine Bromide
16571-833	Pryidostigmine Bromide	Pyridostigmine Bromide
24689-104	PRYIDOSTIGMINE BROMIDE	pyridostigmine bromide
0115-1404	Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE
0115-2134	Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE
0115-3511	Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE
0904-6622	pyridostigmine bromide	pyridostigmine bromide
47781-335	Pyridostigmine Bromide	Pyridostigmine Bromide