levofloxacin

Generic: levofloxacin

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levofloxacin
Generic Name levofloxacin
Labeler chartwell rx, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

levofloxacin 750 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-657
Product ID 62135-657_10182104-3b25-869e-e063-6394a90ab116
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076890
Listing Expiration 2026-12-31
Marketing Start 2012-03-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135657
Hyphenated Format 62135-657

Supplemental Identifiers

RxCUI
199884 199885 311296
UPC
0362135655143 0362135656508 0362135657147
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 ANDA076890 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/1
source: ndc
Packaging
  • 14 TABLET in 1 BOTTLE (62135-657-14)
source: ndc

Packages (1)

62135-657-14 14 TABLET in 1 BOTTLE (62135-657-14)

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": "10182104-3b25-869e-e063-6394a90ab116", "openfda": {"nui": ["N0000193223", "M0372253"], "upc": ["0362135655143", "0362135656508", "0362135657147"], "unii": ["6GNT3Y5LMF"], "rxcui": ["199884", "199885", "311296"], "spl_set_id": ["5c6c117c-9d91-48f4-9aaa-ee70b99218c2"], "pharm_class_cs": ["Fluoroquinolones [CS]"], "pharm_class_epc": ["Fluoroquinolone Antibacterial [EPC]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "14 TABLET in 1 BOTTLE (62135-657-14)", "package_ndc": "62135-657-14", "marketing_start_date": "20240119"}], "brand_name": "Levofloxacin", "product_id": "62135-657_10182104-3b25-869e-e063-6394a90ab116", "dosage_form": "TABLET", "product_ndc": "62135-657", "generic_name": "Levofloxacin", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levofloxacin", "active_ingredients": [{"name": "LEVOFLOXACIN", "strength": "750 mg/1"}], "application_number": "ANDA076890", "marketing_category": "ANDA", "marketing_start_date": "20120330", "listing_expiration_date": "20261231"}