levofloxacin

Generic: levofloxacin

Labeler: lannett company, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levofloxacin
Generic Name levofloxacin
Labeler lannett company, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

levofloxacin 25 mg/mL

Manufacturer
Lannett Company, Inc.

Identifiers & Regulatory

Product NDC 0527-1948
Product ID 0527-1948_01e976a4-eb3a-4d1a-a384-46222c20afc5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205222
Listing Expiration 2026-12-31
Marketing Start 2018-05-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05271948
Hyphenated Format 0527-1948

Supplemental Identifiers

RxCUI
477391
UPC
0305271948663
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 ANDA205222 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (0527-1948-66) / 100 mL in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (0527-1948-68) / 200 mL in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (0527-1948-70) / 480 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (3)

0527-1948-66 1 BOTTLE, PLASTIC in 1 CARTON (0527-1948-66) / 100 mL in 1 BOTTLE, PLASTIC 0527-1948-68 1 BOTTLE, PLASTIC in 1 CARTON (0527-1948-68) / 200 mL in 1 BOTTLE, PLASTIC 0527-1948-70 1 BOTTLE, PLASTIC in 1 CARTON (0527-1948-70) / 480 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

levofloxacin (25 mg/mL)

Linked Drug Pages (1)

Levofloxacin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "01e976a4-eb3a-4d1a-a384-46222c20afc5", "openfda": {"nui": ["N0000193223", "M0372253"], "upc": ["0305271948663"], "unii": ["6GNT3Y5LMF"], "rxcui": ["477391"], "spl_set_id": ["362fb864-3afb-4841-a7c4-b64b1346aba0"], "pharm_class_cs": ["Fluoroquinolones [CS]"], "pharm_class_epc": ["Fluoroquinolone Antibacterial [EPC]"], "manufacturer_name": ["Lannett Company, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (0527-1948-66)  / 100 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0527-1948-66", "marketing_start_date": "20180525"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (0527-1948-68)  / 200 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0527-1948-68", "marketing_start_date": "20180525"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (0527-1948-70)  / 480 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0527-1948-70", "marketing_start_date": "20180525"}], "brand_name": "Levofloxacin", "product_id": "0527-1948_01e976a4-eb3a-4d1a-a384-46222c20afc5", "dosage_form": "SOLUTION", "product_ndc": "0527-1948", "generic_name": "Levofloxacin", "labeler_name": "Lannett Company, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levofloxacin", "active_ingredients": [{"name": "LEVOFLOXACIN", "strength": "25 mg/mL"}], "application_number": "ANDA205222", "marketing_category": "ANDA", "marketing_start_date": "20180525", "listing_expiration_date": "20261231"}