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 750 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 51655-327
Product ID 51655-327_48eb0bd1-3a7e-3ba5-e063-6294a90a98c3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076710
Listing Expiration 2027-12-31
Marketing Start 2022-11-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51655327
Hyphenated Format 51655-327

Supplemental Identifiers

RxCUI
311296
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
  • 750 mg/1
source: ndc
Packaging
  • 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-327-07)
  • 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-327-53)
  • 5 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-327-55)
  • 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-327-84)
source: ndc

Packages (4)

51655-327-07 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-327-07) 51655-327-53 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-327-53) 51655-327-55 5 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-327-55) 51655-327-84 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-327-84)

Ingredients (1)

levofloxacin (750 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": "48eb0bd1-3a7e-3ba5-e063-6294a90a98c3", "openfda": {"nui": ["N0000193223", "M0372253"], "unii": ["6GNT3Y5LMF"], "rxcui": ["311296"], "spl_set_id": ["f2f090c2-3ee1-7689-e053-2995a90abe38"], "pharm_class_cs": ["Fluoroquinolones [CS]"], "pharm_class_epc": ["Fluoroquinolone Antibacterial [EPC]"], "manufacturer_name": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-327-07)", "package_ndc": "51655-327-07", "marketing_start_date": "20230220"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-327-53)", "package_ndc": "51655-327-53", "marketing_start_date": "20230320"}, {"sample": false, "description": "5 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-327-55)", "package_ndc": "51655-327-55", "marketing_start_date": "20221128"}, {"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-327-84)", "package_ndc": "51655-327-84", "marketing_start_date": "20240119"}], "brand_name": "Levofloxacin", "product_id": "51655-327_48eb0bd1-3a7e-3ba5-e063-6294a90a98c3", "dosage_form": "TABLET, FILM COATED", "product_ndc": "51655-327", "generic_name": "Levofloxacin", "labeler_name": "Northwind Health Company, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levofloxacin", "active_ingredients": [{"name": "LEVOFLOXACIN", "strength": "750 mg/1"}], "application_number": "ANDA076710", "marketing_category": "ANDA", "marketing_start_date": "20221128", "listing_expiration_date": "20271231"}