levofloxacin

Generic: levofloxacin

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levofloxacin
Generic Name levofloxacin
Labeler micro labs limited
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

levofloxacin 15 mg/mL

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-168
Product ID 42571-168_833c5e2e-8b64-3b8f-e053-2a91aa0ab453
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205600
Listing Expiration 2026-12-31
Marketing Start 2019-04-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42571168
Hyphenated Format 42571-168

Supplemental Identifiers

RxCUI
545118
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 ANDA205600 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 15 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (42571-168-25) / 5 mL in 1 BOTTLE
source: ndc

Packages (1)

42571-168-25 1 BOTTLE in 1 CARTON (42571-168-25) / 5 mL in 1 BOTTLE

Ingredients (1)

levofloxacin (15 mg/mL)

Linked Drug Pages (1)

LEVOFLOXACIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "833c5e2e-8b64-3b8f-e053-2a91aa0ab453", "openfda": {"nui": ["N0000193223", "M0372253"], "unii": ["6GNT3Y5LMF"], "rxcui": ["545118"], "spl_set_id": ["c0417827-3c49-4dbd-97a8-3e2bb509d157"], "pharm_class_cs": ["Fluoroquinolones [CS]"], "pharm_class_epc": ["Fluoroquinolone Antibacterial [EPC]"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (42571-168-25)  / 5 mL in 1 BOTTLE", "package_ndc": "42571-168-25", "marketing_start_date": "20190416"}], "brand_name": "LEVOFLOXACIN", "product_id": "42571-168_833c5e2e-8b64-3b8f-e053-2a91aa0ab453", "dosage_form": "SOLUTION/ DROPS", "product_ndc": "42571-168", "generic_name": "Levofloxacin", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEVOFLOXACIN", "active_ingredients": [{"name": "LEVOFLOXACIN", "strength": "15 mg/mL"}], "application_number": "ANDA205600", "marketing_category": "ANDA", "marketing_start_date": "20190416", "listing_expiration_date": "20261231"}