ofloxacin

Generic: ofloxacin

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ofloxacin
Generic Name ofloxacin
Labeler proficient rx lp
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

ofloxacin 3 mg/mL

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-734
Product ID 63187-734_6fdf3036-94ca-4ad4-ae32-395156115512
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 63187734
Hyphenated Format 63187-734

Supplemental Identifiers

RxCUI
312075
UNII
A4P49JAZ9H
NUI
N0000175937 M0023650

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 (63187-734-05) / 5 mL in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (63187-734-10) / 10 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

63187-734-05 1 BOTTLE, PLASTIC in 1 CARTON (63187-734-05) / 5 mL in 1 BOTTLE, PLASTIC 63187-734-10 1 BOTTLE, PLASTIC in 1 CARTON (63187-734-10) / 10 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": "6fdf3036-94ca-4ad4-ae32-395156115512", "openfda": {"nui": ["N0000175937", "M0023650"], "unii": ["A4P49JAZ9H"], "rxcui": ["312075"], "spl_set_id": ["a2089612-de4b-4d78-b311-fa2524bd37f6"], "pharm_class_cs": ["Quinolones [CS]"], "pharm_class_epc": ["Quinolone Antimicrobial [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (63187-734-05)  / 5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "63187-734-05", "marketing_start_date": "20160701"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (63187-734-10)  / 10 mL in 1 BOTTLE, PLASTIC", "package_ndc": "63187-734-10", "marketing_start_date": "20160701"}], "brand_name": "Ofloxacin", "product_id": "63187-734_6fdf3036-94ca-4ad4-ae32-395156115512", "dosage_form": "SOLUTION", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "63187-734", "generic_name": "Ofloxacin", "labeler_name": "Proficient Rx LP", "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"}