moxifloxacin hydrochloride

Generic: moxifloxacin hydrochloride

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name moxifloxacin hydrochloride
Generic Name moxifloxacin hydrochloride
Labeler upsher-smith laboratories, llc
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

moxifloxacin hydrochloride 5 mg/mL

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 0832-1410
Product ID 0832-1410_b740604e-1d7a-4382-90ca-26b0186f7a93
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212616
Listing Expiration 2026-12-31
Marketing Start 2021-02-10

Pharmacologic Class

Classes
fluoroquinolone antibacterial [epc] fluoroquinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 08321410
Hyphenated Format 0832-1410

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 hydrochloride (source: ndc)
Generic Name moxifloxacin hydrochloride (source: ndc)
Application Number ANDA212616 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (0832-1410-03) / 3 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

0832-1410-03 1 BOTTLE, PLASTIC in 1 CARTON (0832-1410-03) / 3 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

moxifloxacin hydrochloride (5 mg/mL)

Linked Drug Pages (1)

Moxifloxacin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "b740604e-1d7a-4382-90ca-26b0186f7a93", "openfda": {"unii": ["C53598599T"], "rxcui": ["403818"], "spl_set_id": ["5a5d72e2-aa39-4ead-af72-d3cabe72a5b7"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (0832-1410-03)  / 3 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0832-1410-03", "marketing_start_date": "20210210"}], "brand_name": "Moxifloxacin Hydrochloride", "product_id": "0832-1410_b740604e-1d7a-4382-90ca-26b0186f7a93", "dosage_form": "SOLUTION", "pharm_class": ["Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "0832-1410", "generic_name": "Moxifloxacin Hydrochloride", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Moxifloxacin Hydrochloride", "active_ingredients": [{"name": "MOXIFLOXACIN HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA212616", "marketing_category": "ANDA", "marketing_start_date": "20210210", "listing_expiration_date": "20261231"}