NDC 0065-8531

CIPRO HC

Ciprofloxacin Hydrochloride And Hydrocortisone

CIPRO HC is a Auricular (otic) Suspension in the Human Prescription Drug category. It is labeled and distributed by Alcon Laboratories, Inc.. The primary component is Ciprofloxacin Hydrochloride; Hydrocortisone.

• Product ID: 0065-8531_0af4cbe7-cd2e-4e9d-bf23-bc9fce3dee38
• NDC: 0065-8531
• Product Type: Human Prescription Drug
• Proprietary Name: CIPRO HC
• Generic Name: Ciprofloxacin Hydrochloride And Hydrocortisone
• Dosage Form: Suspension
• Route of Administration: AURICULAR (OTIC)
• Marketing Start Date: 1999-03-15
• Marketing Category: NDA / NDA
• Application Number: NDA020805
• Labeler Name: Alcon Laboratories, Inc.
• Substance Name: CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE
• Active Ingredient Strength: 2 mg/mL; mg/mL
• Pharm Classes: Quinolone Antimicrobial [EPC],Quinolones [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0065-8531-10

10 mL in 1 BOTTLE, GLASS (0065-8531-10)

• Marketing Start Date: 1999-03-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0065-8531-10 [00065853110]

CIPRO HC SUSPENSION

• Marketing Category: NDA
• Application Number: NDA020805
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1999-03-15

NDC 0065-8531-23 [00065853123]

CIPRO HC SUSPENSION

• Marketing Category: NDA
• Application Number: NDA020805
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1999-03-15
• Marketing End Date: 2011-09-08

Drug Details

Active Ingredients

Ingredient	Strength
CIPROFLOXACIN HYDROCHLORIDE	2 mg/mL

OpenFDA Data

• SPL SET ID: 70b19501-34b6-4f95-a8dd-dd3e67d22399
• Manufacturer:
  • Alcon Laboratories, Inc.
• UNII:
  • 4BA73M5E37
  • WI4X0X7BPJ
• RxNorm Concept Unique ID - RxCUI:
  • 213320
  • 309305

Pharmacological Class

• Quinolone Antimicrobial [EPC]
• Quinolones [CS]
• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]

NDC Crossover Matching brand name "CIPRO HC" or generic name "Ciprofloxacin Hydrochloride And Hydrocortisone"

NDC	Brand Name	Generic Name
0065-8531	CIPRO	ciprofloxacin hydrochloride and hydrocortisone
0078-0855	CIPRO	ciprofloxacin hydrochloride and hydrocortisone
50090-1656	CIPRO	ciprofloxacin hydrochloride and hydrocortisone
50090-6043	CIPRO	ciprofloxacin hydrochloride and hydrocortisone
76420-273	CIPRO	ciprofloxacin hydrochloride and hydrocortisone