ofloxacin

Generic: ofloxacin

Labeler: cadila pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ofloxacin
Generic Name ofloxacin
Labeler cadila pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ofloxacin 300 mg/1

Manufacturer
Cadila Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 71209-098
Product ID 71209-098_85ff09b7-6b73-44bd-a654-11fbab9efdbe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091656
Listing Expiration 2026-12-31
Marketing Start 2015-12-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71209098
Hyphenated Format 71209-098

Supplemental Identifiers

RxCUI
198048 198049 198050
UPC
0371209097109 0371209098052 0371209099059 0371209099028 0371209098106 0371209098021 0371209099103
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
  • 300 mg/1
source: ndc
Packaging
  • 50 TABLET, FILM COATED in 1 BOTTLE (71209-098-02)
  • 100 TABLET, FILM COATED in 1 BOTTLE (71209-098-05)
  • 500 TABLET, FILM COATED in 1 BOTTLE (71209-098-10)
source: ndc

Packages (3)

71209-098-02 50 TABLET, FILM COATED in 1 BOTTLE (71209-098-02) 71209-098-05 100 TABLET, FILM COATED in 1 BOTTLE (71209-098-05) 71209-098-10 500 TABLET, FILM COATED in 1 BOTTLE (71209-098-10)

Ingredients (1)

ofloxacin (300 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": "85ff09b7-6b73-44bd-a654-11fbab9efdbe", "openfda": {"nui": ["N0000175937", "M0023650"], "upc": ["0371209097109", "0371209098052", "0371209099059", "0371209099028", "0371209098106", "0371209098021", "0371209099103"], "unii": ["A4P49JAZ9H"], "rxcui": ["198048", "198049", "198050"], "spl_set_id": ["c677b35c-0432-4ee5-af57-1f95449c48b6"], "pharm_class_cs": ["Quinolones [CS]"], "pharm_class_epc": ["Quinolone Antimicrobial [EPC]"], "manufacturer_name": ["Cadila Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 TABLET, FILM COATED in 1 BOTTLE (71209-098-02)", "package_ndc": "71209-098-02", "marketing_start_date": "20151229"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (71209-098-05)", "package_ndc": "71209-098-05", "marketing_start_date": "20151229"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (71209-098-10)", "package_ndc": "71209-098-10", "marketing_start_date": "20151229"}], "brand_name": "OFLOXACIN", "product_id": "71209-098_85ff09b7-6b73-44bd-a654-11fbab9efdbe", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "71209-098", "generic_name": "OFLOXACIN", "labeler_name": "Cadila Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OFLOXACIN", "active_ingredients": [{"name": "OFLOXACIN", "strength": "300 mg/1"}], "application_number": "ANDA091656", "marketing_category": "ANDA", "marketing_start_date": "20151229", "listing_expiration_date": "20261231"}