ofloxacin

Generic: ofloxacin

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ofloxacin
Generic Name ofloxacin
Labeler rising pharma holdings, inc.
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

ofloxacin 3 mg/mL

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 64980-515
Product ID 64980-515_8a9b999e-89bc-44ec-b974-729f66dc0bfa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078559
Listing Expiration 2026-12-31
Marketing Start 2014-12-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64980515
Hyphenated Format 64980-515

Supplemental Identifiers

RxCUI
312075
UPC
0364980515016 0364980515054
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 ANDA078559 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (64980-515-01) / 10 mL in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (64980-515-05) / 5 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

64980-515-01 1 BOTTLE, PLASTIC in 1 CARTON (64980-515-01) / 10 mL in 1 BOTTLE, PLASTIC 64980-515-05 1 BOTTLE, PLASTIC in 1 CARTON (64980-515-05) / 5 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

ofloxacin (3 mg/mL)

Linked Drug Pages (1)

Ofloxacin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "8a9b999e-89bc-44ec-b974-729f66dc0bfa", "openfda": {"nui": ["N0000175937", "M0023650"], "upc": ["0364980515016", "0364980515054"], "unii": ["A4P49JAZ9H"], "rxcui": ["312075"], "spl_set_id": ["c76d8dc7-9a66-471b-814b-ef7f3605ec93"], "pharm_class_cs": ["Quinolones [CS]"], "pharm_class_epc": ["Quinolone Antimicrobial [EPC]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (64980-515-01)  / 10 mL in 1 BOTTLE, PLASTIC", "package_ndc": "64980-515-01", "marketing_start_date": "20171101"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (64980-515-05)  / 5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "64980-515-05", "marketing_start_date": "20171101"}], "brand_name": "Ofloxacin", "product_id": "64980-515_8a9b999e-89bc-44ec-b974-729f66dc0bfa", "dosage_form": "SOLUTION", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "64980-515", "generic_name": "Ofloxacin", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ofloxacin", "active_ingredients": [{"name": "OFLOXACIN", "strength": "3 mg/mL"}], "application_number": "ANDA078559", "marketing_category": "ANDA", "marketing_start_date": "20141215", "listing_expiration_date": "20261231"}