NDC 50383-189

Gatifloxacin

Gatifloxacin

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

• Product ID: 50383-189_2145dbd3-6bcf-4473-b30b-7ad660f83cad
• NDC: 50383-189
• Product Type: Human Prescription Drug
• Proprietary Name: Gatifloxacin
• Generic Name: Gatifloxacin
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2014-10-06
• Marketing Category: ANDA / ANDA
• Application Number: ANDA203189
• Labeler Name: Akorn
• Substance Name: GATIFLOXACIN ANHYDROUS
• Active Ingredient Strength: 5 mg/mL
• Pharm Classes: Quinolone Antimicrobial [EPC], Quinolones [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 50383-189-02

1 BOTTLE, DROPPER in 1 CARTON (50383-189-02) > 2.5 mL in 1 BOTTLE, DROPPER

• Marketing Start Date: 2014-10-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50383-189-02 [50383018902]

Gatifloxacin SOLUTION/ DROPS

• Marketing Category: ANDA
• Application Number: ANDA203189
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-10-06

Drug Details

Active Ingredients

Ingredient	Strength
GATIFLOXACIN ANHYDROUS	5 mg/mL

OpenFDA Data

• SPL SET ID: 14312de6-67d4-4de2-854c-ef764090dd83
• Manufacturer:
  • Hi-Tech Pharmacal Co., Inc.
• UNII:
  • 81485Y3A9A
• RxNorm Concept Unique ID - RxCUI:
  • 992395

Pharmacological Class

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

Medicade Reported Pricing

50383018902 GATIFLOXACIN 0.5% EYE DROPS

Pricing Unit: ML | Drug Type:

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