NDC 50419-789

Cipro

Ciprofloxacin

Cipro is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Bayer Healthcare Pharmaceuticals Inc.. The primary component is Ciprofloxacin; Ciprofloxacin Hydrochloride.

• Product ID: 50419-789_6a45ebbd-49c4-4177-8ee3-ad4e02b780da
• NDC: 50419-789
• Product Type: Human Prescription Drug
• Proprietary Name: Cipro
• Generic Name: Ciprofloxacin
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2012-10-01
• Marketing Category: NDA / NDA
• Application Number: NDA021473
• Labeler Name: Bayer HealthCare Pharmaceuticals Inc.
• Substance Name: CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE
• Active Ingredient Strength: 452 mg/1; 1/1
• Pharm Classes: Quinolone Antimicrobial [EPC],Quinolones [CS],Quinolone Antimicrobial [EPC],Quinolones [CS]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 50419-789-01

50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50419-789-01)

• Marketing Start Date: 2012-10-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50419-789-01 [50419078901]

Cipro TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA021473
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-10-01
• Marketing End Date: 2016-07-27

NDC 50419-789-00 [50419078900]

Cipro TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA021473
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-10-01
• Marketing End Date: 2016-07-27

Drug Details

Active Ingredients

Ingredient	Strength
CIPROFLOXACIN	452.2 mg/1

OpenFDA Data

• SPL SET ID: 4a3cec22-74d0-440a-a9f4-4d5f02e8417a
• Manufacturer:
  • Bayer HealthCare Pharmaceuticals Inc.
• UNII:
  • 5E8K9I0O4U
  • 4BA73M5E37
• RxNorm Concept Unique ID - RxCUI:
  • 359383
  • 847488
  • 403921
  • 899122
• UPC Code:
  • 0350419788014

Pharmacological Class

• Quinolone Antimicrobial [EPC]
• Quinolones [CS]
• Quinolone Antimicrobial [EPC]
• Quinolones [CS]

NDC Crossover Matching brand name "Cipro" or generic name "Ciprofloxacin"

NDC	Brand Name	Generic Name
0065-8531	CIPRO	ciprofloxacin hydrochloride and hydrocortisone
0078-0855	CIPRO	ciprofloxacin hydrochloride and hydrocortisone
50419-759	Cipro	Cipro
50419-777	Cipro	Cipro
50419-789	Cipro	Cipro
50419-754	Cipro	Cipro
50419-788	Cipro	Cipro
50419-758	Cipro	Cipro
50419-773	Cipro	Cipro
80425-0095	Cipro	Cipro
0143-2037	Ciprofloxacin	Ciprofloxacin
0143-9927	Ciprofloxacin	Ciprofloxacin
0143-9928	Ciprofloxacin	Ciprofloxacin
0143-9929	Ciprofloxacin	Ciprofloxacin
0172-5312	Ciprofloxacin	Ciprofloxacin
0179-0188	Ciprofloxacin	Ciprofloxacin
0378-1743	Ciprofloxacin	ciprofloxacin
0378-1745	Ciprofloxacin	ciprofloxacin
0378-7098	Ciprofloxacin	ciprofloxacin
0409-4777	CIPROFLOXACIN	CIPROFLOXACIN
0409-2300	Ciprofloxacin in Dextrose	ciprofloxacin
0409-3300	Ciprofloxacin in Dextrose	ciprofloxacin