NDC 21695-969

CIPRODEX

Ciprofloxacin And Dexamethasone

CIPRODEX is a Auricular (otic) Suspension in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Ciprofloxacin Hydrochloride; Dexamethasone.

• Product ID: 21695-969_895c2307-aeeb-49fd-ac3d-750a463fc3ef
• NDC: 21695-969
• Product Type: Human Prescription Drug
• Proprietary Name: CIPRODEX
• Generic Name: Ciprofloxacin And Dexamethasone
• Dosage Form: Suspension
• Route of Administration: AURICULAR (OTIC)
• Marketing Start Date: 2003-08-15
• Marketing Category: NDA / NDA
• Application Number: NDA021537
• Labeler Name: Rebel Distributors Corp
• Substance Name: CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE
• Active Ingredient Strength: 3 mg/mL; mg/mL
• Pharm Classes: Quinolone Antimicrobial [EPC],Quinolones [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 21695-969-75

7.5 mL in 1 BOTTLE, PLASTIC (21695-969-75)

• Marketing Start Date: 2003-08-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 21695-969-75 [21695096975]

CIPRODEX SUSPENSION

• Marketing Category: NDA
• Application Number: NDA021537
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2003-08-15
• Inactivation Date: 2019-09-24

Drug Details

Active Ingredients

Ingredient	Strength
CIPROFLOXACIN HYDROCHLORIDE	3 mg/mL

OpenFDA Data

• SPL SET ID: 895c2307-aeeb-49fd-ac3d-750a463fc3ef
• Manufacturer:
  • Rebel Distributors Corp
• UNII:
  • 7S5I7G3JQL
  • 4BA73M5E37
• RxNorm Concept Unique ID - RxCUI:
  • 403908
  • 404630

Pharmacological Class

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

NDC Crossover Matching brand name "CIPRODEX" or generic name "Ciprofloxacin And Dexamethasone"

NDC	Brand Name	Generic Name
0065-8533	CIPRODEX	ciprofloxacin and dexamethasone
0078-0799	CIPRODEX	ciprofloxacin and dexamethasone
21695-969	CIPRODEX	ciprofloxacin and dexamethasone
68071-1629	CIPRODEX	ciprofloxacin and dexamethasone
71205-309	CIPRODEX	ciprofloxacin and dexamethasone
0781-6186	Ciprofloxacin and Dexamethasone	ciprofloxacin and dexamethasone
16714-628	Ciprofloxacin and Dexamethasone	Ciprofloxacin and Dexamethasone
43598-326	Ciprofloxacin and Dexamethasone	Ciprofloxacin and Dexamethasone
62756-427	Ciprofloxacin and dexamethasone	Ciprofloxacin and dexamethasone
63629-8797	Ciprofloxacin and Dexamethasone	ciprofloxacin and dexamethasone