levofloxacin

Generic: levofloxacin

Labeler: northwind health company, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levofloxacin
Generic Name levofloxacin
Labeler northwind health company, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

levofloxacin 250 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 51655-947
Product ID 51655-947_49748fcf-7277-a6ad-e063-6394a90a1107
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076710
Listing Expiration 2027-12-31
Marketing Start 2023-02-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51655947
Hyphenated Format 51655-947

Supplemental Identifiers

RxCUI
199884
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
  • 250 mg/1
source: ndc
Packaging
  • 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-947-53)
source: ndc

Packages (1)

51655-947-53 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-947-53)

Ingredients (1)

levofloxacin (250 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": "49748fcf-7277-a6ad-e063-6394a90a1107", "openfda": {"nui": ["N0000193223", "M0372253"], "unii": ["6GNT3Y5LMF"], "rxcui": ["199884"], "spl_set_id": ["f780bb91-483a-d1a6-e053-6294a90ab74b"], "pharm_class_cs": ["Fluoroquinolones [CS]"], "pharm_class_epc": ["Fluoroquinolone Antibacterial [EPC]"], "manufacturer_name": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-947-53)", "package_ndc": "51655-947-53", "marketing_start_date": "20230221"}], "brand_name": "Levofloxacin", "product_id": "51655-947_49748fcf-7277-a6ad-e063-6394a90a1107", "dosage_form": "TABLET, FILM COATED", "product_ndc": "51655-947", "generic_name": "Levofloxacin", "labeler_name": "Northwind Health Company, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levofloxacin", "active_ingredients": [{"name": "LEVOFLOXACIN", "strength": "250 mg/1"}], "application_number": "ANDA076710", "marketing_category": "ANDA", "marketing_start_date": "20230221", "listing_expiration_date": "20271231"}