levofloxacin

Generic: levofloxacin

Labeler: redpharm drug
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levofloxacin
Generic Name levofloxacin
Labeler redpharm drug
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

levofloxacin 750 mg/1

Manufacturer
Redpharm Drug

Identifiers & Regulatory

Product NDC 67296-2187
Product ID 67296-2187_4c5a1f30-3b2b-c5c1-e063-6394a90a0d6a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077652
Listing Expiration 2027-12-31
Marketing Start 2022-01-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 672962187
Hyphenated Format 67296-2187

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 ANDA077652 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/1
source: ndc
Packaging
  • 5 TABLET, FILM COATED in 1 BOTTLE (67296-2187-5)
  • 7 TABLET, FILM COATED in 1 BOTTLE (67296-2187-7)
  • 8 TABLET, FILM COATED in 1 BOTTLE (67296-2187-8)
source: ndc

Packages (3)

67296-2187-5 5 TABLET, FILM COATED in 1 BOTTLE (67296-2187-5) 67296-2187-7 7 TABLET, FILM COATED in 1 BOTTLE (67296-2187-7) 67296-2187-8 8 TABLET, FILM COATED in 1 BOTTLE (67296-2187-8)

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": "4c5a1f30-3b2b-c5c1-e063-6394a90a0d6a", "openfda": {"nui": ["N0000193223", "M0372253"], "unii": ["6GNT3Y5LMF"], "rxcui": ["311296"], "spl_set_id": ["44f31105-5fc9-43d4-e063-6294a90a510f"], "pharm_class_cs": ["Fluoroquinolones [CS]"], "pharm_class_epc": ["Fluoroquinolone Antibacterial [EPC]"], "manufacturer_name": ["Redpharm Drug"]}, "finished": true, "packaging": [{"sample": true, "description": "5 TABLET, FILM COATED in 1 BOTTLE (67296-2187-5)", "package_ndc": "67296-2187-5", "marketing_start_date": "20220110"}, {"sample": false, "description": "7 TABLET, FILM COATED in 1 BOTTLE (67296-2187-7)", "package_ndc": "67296-2187-7", "marketing_start_date": "20220110"}, {"sample": false, "description": "8 TABLET, FILM COATED in 1 BOTTLE (67296-2187-8)", "package_ndc": "67296-2187-8", "marketing_start_date": "20220110"}], "brand_name": "levofloxacin", "product_id": "67296-2187_4c5a1f30-3b2b-c5c1-e063-6394a90a0d6a", "dosage_form": "TABLET, FILM COATED", "product_ndc": "67296-2187", "generic_name": "levofloxacin", "labeler_name": "Redpharm Drug", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "levofloxacin", "active_ingredients": [{"name": "LEVOFLOXACIN", "strength": "750 mg/1"}], "application_number": "ANDA077652", "marketing_category": "ANDA", "marketing_start_date": "20220110", "listing_expiration_date": "20271231"}