ofloxacin

Generic: ofloxacin

Labeler: nivagen pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ofloxacin
Generic Name ofloxacin
Labeler nivagen pharmaceuticals, inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

ofloxacin 400 mg/1

Manufacturer
Nivagen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 75834-112
Product ID 75834-112_67a823b3-3e2d-4483-98e5-99fbddc0c8f5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091656
Listing Expiration 2026-12-31
Marketing Start 2016-07-15

Pharmacologic Class

Established (EPC)
quinolone antimicrobial [epc]
Chemical Structure
quinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 75834112
Hyphenated Format 75834-112

Supplemental Identifiers

RxCUI
198048 198049 198050
UPC
0375834112503 0375834119502 0375834120508
UNII
A4P49JAZ9H
NUI
N0000175937 M0023650

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ofloxacin (source: ndc)
Generic Name ofloxacin (source: ndc)
Application Number ANDA091656 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 TABLET, COATED in 1 BOTTLE (75834-112-01)
  • 500 TABLET, COATED in 1 BOTTLE (75834-112-05)
  • 50 TABLET, COATED in 1 BOTTLE (75834-112-50)
source: ndc

Packages (3)

75834-112-01 100 TABLET, COATED in 1 BOTTLE (75834-112-01) 75834-112-05 500 TABLET, COATED in 1 BOTTLE (75834-112-05) 75834-112-50 50 TABLET, COATED in 1 BOTTLE (75834-112-50)

Ingredients (1)

ofloxacin (400 mg/1)

Linked Drug Pages (1)

OFLOXACIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "67a823b3-3e2d-4483-98e5-99fbddc0c8f5", "openfda": {"nui": ["N0000175937", "M0023650"], "upc": ["0375834112503", "0375834119502", "0375834120508"], "unii": ["A4P49JAZ9H"], "rxcui": ["198048", "198049", "198050"], "spl_set_id": ["ee1bf431-97fa-4aba-9cc3-0cfcea779ca2"], "pharm_class_cs": ["Quinolones [CS]"], "pharm_class_epc": ["Quinolone Antimicrobial [EPC]"], "manufacturer_name": ["Nivagen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (75834-112-01)", "package_ndc": "75834-112-01", "marketing_start_date": "20160715"}, {"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE (75834-112-05)", "package_ndc": "75834-112-05", "marketing_start_date": "20160715"}, {"sample": false, "description": "50 TABLET, COATED in 1 BOTTLE (75834-112-50)", "package_ndc": "75834-112-50", "marketing_start_date": "20160715"}], "brand_name": "OFLOXACIN", "product_id": "75834-112_67a823b3-3e2d-4483-98e5-99fbddc0c8f5", "dosage_form": "TABLET, COATED", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "75834-112", "generic_name": "OFLOXACIN", "labeler_name": "Nivagen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OFLOXACIN", "active_ingredients": [{"name": "OFLOXACIN", "strength": "400 mg/1"}], "application_number": "ANDA091656", "marketing_category": "ANDA", "marketing_start_date": "20160715", "listing_expiration_date": "20261231"}