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
AURICULAR (OTIC)
Active Ingredients

ofloxacin 3 mg/mL

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 64980-432
Product ID 64980-432_53f7e16a-6146-4c09-b3bf-4af9984f5b15
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215038
Listing Expiration 2026-12-31
Marketing Start 2022-07-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64980432
Hyphenated Format 64980-432

Supplemental Identifiers

RxCUI
242446
UPC
0364980432054 0364980432016
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 ANDA215038 (source: ndc)
Routes
AURICULAR (OTIC)
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (64980-432-01) / 10 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (64980-432-05) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

64980-432-01 1 BOTTLE, DROPPER in 1 CARTON (64980-432-01) / 10 mL in 1 BOTTLE, DROPPER 64980-432-05 1 BOTTLE, DROPPER in 1 CARTON (64980-432-05) / 5 mL in 1 BOTTLE, DROPPER

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": ["AURICULAR (OTIC)"], "spl_id": "53f7e16a-6146-4c09-b3bf-4af9984f5b15", "openfda": {"nui": ["N0000175937", "M0023650"], "upc": ["0364980432054", "0364980432016"], "unii": ["A4P49JAZ9H"], "rxcui": ["242446"], "spl_set_id": ["2e912ed6-51e8-40c3-bf10-2af092c63be8"], "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, DROPPER in 1 CARTON (64980-432-01)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "64980-432-01", "marketing_start_date": "20220701"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (64980-432-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "64980-432-05", "marketing_start_date": "20220701"}], "brand_name": "Ofloxacin", "product_id": "64980-432_53f7e16a-6146-4c09-b3bf-4af9984f5b15", "dosage_form": "SOLUTION", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "64980-432", "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": "ANDA215038", "marketing_category": "ANDA", "marketing_start_date": "20220701", "listing_expiration_date": "20261231"}