levofloxacin

Generic: levofloxacin

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levofloxacin
Generic Name levofloxacin
Labeler remedyrepack inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

levofloxacin 500 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-0453
Product ID 70518-0453_47f6f2fe-c984-3c24-e063-6294a90ac1cc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076710
Listing Expiration 2027-12-31
Marketing Start 2017-04-21

Pharmacologic Class

Established (EPC)
fluoroquinolone antibacterial [epc]
Chemical Structure
fluoroquinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705180453
Hyphenated Format 70518-0453

Supplemental Identifiers

RxCUI
199885
UNII
6GNT3Y5LMF
NUI
N0000193223 M0372253

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 levofloxacin (source: ndc)
Generic Name levofloxacin (source: ndc)
Application Number ANDA076710 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0453-3)
source: ndc

Packages (1)

70518-0453-3 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0453-3)

Ingredients (1)

levofloxacin (500 mg/1)

Linked Drug Pages (1)

Levofloxacin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47f6f2fe-c984-3c24-e063-6294a90ac1cc", "openfda": {"nui": ["N0000193223", "M0372253"], "unii": ["6GNT3Y5LMF"], "rxcui": ["199885"], "spl_set_id": ["f14cf651-a213-4a4f-adb9-f628562af27c"], "pharm_class_cs": ["Fluoroquinolones [CS]"], "pharm_class_epc": ["Fluoroquinolone Antibacterial [EPC]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0453-3)", "package_ndc": "70518-0453-3", "marketing_start_date": "20240513"}], "brand_name": "Levofloxacin", "product_id": "70518-0453_47f6f2fe-c984-3c24-e063-6294a90ac1cc", "dosage_form": "TABLET, FILM COATED", "product_ndc": "70518-0453", "generic_name": "Levofloxacin", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levofloxacin", "active_ingredients": [{"name": "LEVOFLOXACIN", "strength": "500 mg/1"}], "application_number": "ANDA076710", "marketing_category": "ANDA", "marketing_start_date": "20170421", "listing_expiration_date": "20271231"}