levofloxacin

Generic: levofloxacin

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

levofloxacin 750 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-723
Product ID 31722-723_1fa0a846-34d8-d6f5-e063-6394a90a8e54
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202801
Listing Expiration 2026-12-31
Marketing Start 2015-01-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 31722723
Hyphenated Format 31722-723

Supplemental Identifiers

RxCUI
199884 199885 311296
UPC
0331722721509 0331722723206
UNII
6GNT3Y5LMF
NUI
N0000193223 M0372253

Packaging Origin

Original Packager
true

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 ANDA202801 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/1
source: ndc
Packaging
  • 20 TABLET, FILM COATED in 1 BOTTLE (31722-723-20)
  • 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-723-31)
  • 100 TABLET, FILM COATED in 1 BLISTER PACK (31722-723-32)
source: ndc

Packages (3)

31722-723-20 20 TABLET, FILM COATED in 1 BOTTLE (31722-723-20) 31722-723-31 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-723-31) 31722-723-32 100 TABLET, FILM COATED in 1 BLISTER PACK (31722-723-32)

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": "1fa0a846-34d8-d6f5-e063-6394a90a8e54", "openfda": {"nui": ["N0000193223", "M0372253"], "upc": ["0331722721509", "0331722723206"], "unii": ["6GNT3Y5LMF"], "rxcui": ["199884", "199885", "311296"], "spl_set_id": ["b43e9b51-568c-4d84-bbd1-d237120056c4"], "pharm_class_cs": ["Fluoroquinolones [CS]"], "pharm_class_epc": ["Fluoroquinolone Antibacterial [EPC]"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (31722-723-20)", "package_ndc": "31722-723-20", "marketing_start_date": "20150109"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BLISTER PACK (31722-723-31)", "package_ndc": "31722-723-31", "marketing_start_date": "20150109"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BLISTER PACK (31722-723-32)", "package_ndc": "31722-723-32", "marketing_start_date": "20150109"}], "brand_name": "Levofloxacin", "product_id": "31722-723_1fa0a846-34d8-d6f5-e063-6394a90a8e54", "dosage_form": "TABLET, FILM COATED", "product_ndc": "31722-723", "generic_name": "Levofloxacin", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levofloxacin", "active_ingredients": [{"name": "LEVOFLOXACIN", "strength": "750 mg/1"}], "application_number": "ANDA202801", "marketing_category": "ANDA", "marketing_start_date": "20150109", "listing_expiration_date": "20261231"}