NDC 0378-5431

Gatifloxacin

Gatifloxacin

Gatifloxacin is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Gatifloxacin.

• Product ID: 0378-5431_6e7c741c-1750-4d2a-ba6c-f710be10a53b
• NDC: 0378-5431
• Product Type: Human Prescription Drug
• Proprietary Name: Gatifloxacin
• Generic Name: Gatifloxacin
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2019-03-08
• Marketing Category: ANDA / ANDA
• Application Number: ANDA206446
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: GATIFLOXACIN
• Active Ingredient Strength: 5 mg/mL
• Pharm Classes: Quinolone Antimicrobial [EPC],Quinolones [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0378-5431-35

1 BOTTLE in 1 CARTON (0378-5431-35) > 2.5 mL in 1 BOTTLE

• Marketing Start Date: 2019-03-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-5431-35 [00378543135]

Gatifloxacin SOLUTION/ DROPS

• Marketing Category: ANDA
• Application Number: ANDA206446
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-03-08

Drug Details

Active Ingredients

Ingredient	Strength
GATIFLOXACIN	5 mg/mL

OpenFDA Data

• SPL SET ID: 6e7c741c-1750-4d2a-ba6c-f710be10a53b
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • L4618BD7KJ
• RxNorm Concept Unique ID - RxCUI:
  • 992395

Pharmacological Class

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

NDC Crossover Matching brand name "Gatifloxacin" or generic name "Gatifloxacin"

NDC	Brand Name	Generic Name
0378-5431	Gatifloxacin	gatifloxacin
13668-526	Gatifloxacin	Gatifloxacin
50383-189	Gatifloxacin	Gatifloxacin
57297-435	Gatifloxacin	Gatifloxacin
60758-615	gatifloxacin	gatifloxacin
61314-672	Gatifloxacin	gatifloxacin
68180-435	Gatifloxacin	Gatifloxacin
0023-3615	ZYMAXID	gatifloxacin