NDC 63481-421

Coly-Mycin S

Colistin Sulfate, Neomycin Sulfate, Thonzonium Bromide And Hydrocortisone Acetate

Coly-Mycin S is a Auricular (otic) Suspension in the Human Prescription Drug category. It is labeled and distributed by Endo Pharmaceuticals, Inc.. The primary component is Colistin Sulfate; Neomycin Sulfate; Thonzonium Bromide; Hydrocortisone Acetate.

• Product ID: 63481-421_2cc4f0d8-c74a-48c6-ad8a-99b23416d68c
• NDC: 63481-421
• Product Type: Human Prescription Drug
• Proprietary Name: Coly-Mycin S
• Generic Name: Colistin Sulfate, Neomycin Sulfate, Thonzonium Bromide And Hydrocortisone Acetate
• Dosage Form: Suspension
• Route of Administration: AURICULAR (OTIC)
• Marketing Start Date: 2016-04-18
• Marketing End Date: 2020-04-30
• Marketing Category: NDA / NDA
• Application Number: NDA050356
• Labeler Name: Endo Pharmaceuticals, Inc.
• Substance Name: COLISTIN SULFATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE; HYDROCORTISONE ACETATE
• Active Ingredient Strength: 3 mg/mL; mg/mL; mg/mL; mg/mL
• Pharm Classes: Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N

Packaging

NDC 63481-421-05

10 mL in 1 BOTTLE, DROPPER (63481-421-05)

• Marketing Start Date: 2016-04-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63481-421-05 [63481042105]

Coly-Mycin S SUSPENSION

• Marketing Category: NDA
• Application Number: NDA050356
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-04-18
• Marketing End Date: 2020-04-30

Drug Details

Active Ingredients

Ingredient	Strength
COLISTIN SULFATE	3 mg/mL

OpenFDA Data

• SPL SET ID: 256f4083-5b34-4643-a75a-dd1a59a5d964
• Manufacturer:
  • Endo Pharmaceuticals, Inc.
• UNII:
  • WP15DXU577
  • 057Y626693
  • 3X7931PO74
  • JI2B19CR0R
• RxNorm Concept Unique ID - RxCUI:
  • 854995
  • 854992
• UPC Code:
  • 0363481421055

Pharmacological Class

• Aminoglycoside Antibacterial [EPC]
• Aminoglycosides [CS]
• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]

Medicade Reported Pricing

63481042105 COLY-MYCIN S OTIC SUSP DROP

Pricing Unit: ML | Drug Type:

NDC Crossover Matching brand name "Coly-Mycin S" or generic name "Colistin Sulfate, Neomycin Sulfate, Thonzonium Bromide And Hydrocortisone Acetate"

NDC	Brand Name	Generic Name
63481-421	Coly-Mycin S	colistin sulfate, neomycin sulfate, thonzonium bromide and hydrocortisone acetate
63481-529	Cortisporin TC	colistin sulfate, neomycin sulfate, thonzonium bromide and hydrocortisone acetate