levofloxacin
Generic: levofloxacin
Labeler: lupin pharmaceuticals, inc.Drug Facts
Product Profile
Brand Name
levofloxacin
Generic Name
levofloxacin
Labeler
lupin pharmaceuticals, inc.
Dosage Form
TABLET, FILM COATED
Routes
Active Ingredients
levofloxacin 250 mg/1
Manufacturer
Identifiers & Regulatory
Product NDC
68180-240
Product ID
68180-240_04b864a6-b2f7-4e3d-aa12-32a501054b9c
Product Type
HUMAN PRESCRIPTION DRUG
Marketing Category
ANDA
Application Number
ANDA078424
Listing Expiration
2026-12-31
Marketing Start
2011-06-20
Pharmacologic Class
Established (EPC)
Chemical Structure
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
68180240
Hyphenated Format
68180-240
Supplemental Identifiers
RxCUI
UPC
UNII
NUI
Packaging Origin
Original Packager
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
ANDA078424 (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- 250 mg/1
Packaging
- 16 HOW SUPPLIED/STORAGE AND HANDLING Levofloxacin tablets USP are supplied as 250, 500, and 750 mg coated tablets. Levofloxacin tablets USP are packaged in bottles and in unit-dose blister strips in the following configurations: 250 mg tablets are terra cotta pink, oblong shaped, film-coated tablets, imprinted 'L021' (in black ink) on one side and plain on the other side. Bottles of 50 NDC 68180-240-08 Bottles of 100 NDC 68180-240-01 Bottles of 500 NDC 68180-240-02 Unit Dose Blisters of 10x10s NDC 68180-240-13 500 mg tablets are peach, oblong shaped, film-coated tablets, imprinted 'L022' (in black ink) on one side and plain on the other side. Bottles of 50 NDC 68180-241-08 Bottles of 100 NDC 68180-241-01 Bottles of 500 NDC 68180-241-02 Unit Dose Blisters of 10x10s NDC 68180-241-13 750 mg tablets are white, capsule-shaped, film-coated tablets, imprinted 'L023' (in black ink) on one side and plain on the other side. Bottles of 20 NDC 68180-242-20 Bottles of 100 NDC 68180-242-01 Bottles of 500 NDC 68180-242-02 Unit Dose Blisters of 10x10s NDC 68180-242-13 Stored at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] in well-closed containers as described in the USP.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Levofloxacin Tablets USP, 250 mg Bottles of 100 NDC 68180-240-01 Levofloxacin Tables USP, 250 mg Carton of 100 Tablets NDC 68180-240-13 Levofloxacin Tablets USP, 500 mg Bottles of 100 Tablets NDC 68180-241-01 Levofloxacin Tablets USP, 500 mg Carton of 100 Tablets NDC 68180-241-13 Levofloxacin Tablets USP, 750 mg Bottles of 100 Tablets NDC 68180-242-01 Levofloxacin Tablets USP, 750 mg Carton of 100 Tablets NDC 68180-242-13 Image Image Image Image Image Image
Packages (0)
No package records.
Ingredients (1)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "04b864a6-b2f7-4e3d-aa12-32a501054b9c", "openfda": {"nui": ["N0000193223", "M0372253"], "upc": ["0368180240013", "0368180240136"], "unii": ["6GNT3Y5LMF"], "rxcui": ["199884", "199885", "311296"], "spl_set_id": ["4be13bd5-0c39-43c3-9232-b1226ccd4dbc"], "pharm_class_cs": ["Fluoroquinolones [CS]"], "pharm_class_epc": ["Fluoroquinolone Antibacterial [EPC]"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Levofloxacin", "product_id": "68180-240_04b864a6-b2f7-4e3d-aa12-32a501054b9c", "dosage_form": "TABLET, FILM COATED", "product_ndc": "68180-240", "generic_name": "Levofloxacin", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levofloxacin", "active_ingredients": [{"name": "LEVOFLOXACIN", "strength": "250 mg/1"}], "application_number": "ANDA078424", "marketing_category": "ANDA", "marketing_start_date": "20110620", "listing_expiration_date": "20261231"}