moxifloxacin

Generic: moxifloxacin

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

Drug Facts

Product Profile

Brand Name moxifloxacin
Generic Name moxifloxacin
Labeler lupin pharmaceuticals, inc.
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

moxifloxacin hydrochloride 5 mg/mL

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-421
Product ID 68180-421_29272b83-77cf-4cd1-9aed-b80d0cc6edb5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204079
Listing Expiration 2026-12-31
Marketing Start 2020-02-13

Pharmacologic Class

Classes
fluoroquinolone antibacterial [epc] fluoroquinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180421
Hyphenated Format 68180-421

Supplemental Identifiers

RxCUI
403818
UNII
C53598599T

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 moxifloxacin (source: ndc)
Generic Name moxifloxacin (source: ndc)
Application Number ANDA204079 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 3 mL in 1 BOTTLE (68180-421-01)
source: ndc

Packages (1)

68180-421-01 3 mL in 1 BOTTLE (68180-421-01)

Ingredients (1)

moxifloxacin hydrochloride (5 mg/mL)

Linked Drug Pages (1)

MOXIFLOXACIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "29272b83-77cf-4cd1-9aed-b80d0cc6edb5", "openfda": {"unii": ["C53598599T"], "rxcui": ["403818"], "spl_set_id": ["d66f080b-da56-4473-8785-920d9700f72d"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 mL in 1 BOTTLE (68180-421-01)", "package_ndc": "68180-421-01", "marketing_start_date": "20200213"}], "brand_name": "MOXIFLOXACIN", "product_id": "68180-421_29272b83-77cf-4cd1-9aed-b80d0cc6edb5", "dosage_form": "SOLUTION", "pharm_class": ["Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "68180-421", "generic_name": "MOXIFLOXACIN", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MOXIFLOXACIN", "active_ingredients": [{"name": "MOXIFLOXACIN HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA204079", "marketing_category": "ANDA", "marketing_start_date": "20200213", "listing_expiration_date": "20261231"}