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 200 mg/1

Manufacturer
Nivagen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 75834-199
Product ID 75834-199_991170ff-e65c-421f-b7f0-95f78e459844
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091656
Listing Expiration 2026-12-31
Marketing Start 2019-01-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 75834199
Hyphenated Format 75834-199

Supplemental Identifiers

RxCUI
198048 198049 198050
UPC
0375834200507 0375834201504
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
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET, COATED in 1 BOTTLE (75834-199-01)
  • 500 TABLET, COATED in 1 BOTTLE (75834-199-05)
  • 50 TABLET, COATED in 1 BOTTLE (75834-199-50)
source: ndc

Packages (3)

75834-199-01 100 TABLET, COATED in 1 BOTTLE (75834-199-01) 75834-199-05 500 TABLET, COATED in 1 BOTTLE (75834-199-05) 75834-199-50 50 TABLET, COATED in 1 BOTTLE (75834-199-50)

Ingredients (1)

ofloxacin (200 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": "991170ff-e65c-421f-b7f0-95f78e459844", "openfda": {"nui": ["N0000175937", "M0023650"], "upc": ["0375834200507", "0375834201504"], "unii": ["A4P49JAZ9H"], "rxcui": ["198048", "198049", "198050"], "spl_set_id": ["1779c568-d7bb-4bd5-bc29-13bd52ba8a0a"], "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 (75834-199-01)", "package_ndc": "75834-199-01", "marketing_start_date": "20190125"}, {"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE (75834-199-05)", "package_ndc": "75834-199-05", "marketing_start_date": "20190125"}, {"sample": false, "description": "50 TABLET, COATED in 1 BOTTLE (75834-199-50)", "package_ndc": "75834-199-50", "marketing_start_date": "20190125"}], "brand_name": "OFLOXACIN", "product_id": "75834-199_991170ff-e65c-421f-b7f0-95f78e459844", "dosage_form": "TABLET, COATED", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "75834-199", "generic_name": "OFLOXACIN", "labeler_name": "Nivagen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OFLOXACIN", "active_ingredients": [{"name": "OFLOXACIN", "strength": "200 mg/1"}], "application_number": "ANDA091656", "marketing_category": "ANDA", "marketing_start_date": "20190125", "listing_expiration_date": "20261231"}