moxifloxacin hydrochloride

Generic: moxifloxacin hydrochloride

Labeler: somerset therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name moxifloxacin hydrochloride
Generic Name moxifloxacin hydrochloride
Labeler somerset therapeutics, llc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

moxifloxacin hydrochloride 5 mg/mL

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-081
Product ID 70069-081_1a4f432a-c2b2-46bc-88fc-7379c2bbd0a2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209698
Listing Expiration 2026-12-31
Marketing Start 2024-11-25

Pharmacologic Class

Classes
fluoroquinolone antibacterial [epc] fluoroquinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70069081
Hyphenated Format 70069-081

Supplemental Identifiers

RxCUI
403818
UPC
0370069081013
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 ANDA209698 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70069-081-01) / 3 mL in 1 BOTTLE
source: ndc

Packages (1)

70069-081-01 1 BOTTLE in 1 CARTON (70069-081-01) / 3 mL in 1 BOTTLE

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": "1a4f432a-c2b2-46bc-88fc-7379c2bbd0a2", "openfda": {"upc": ["0370069081013"], "unii": ["C53598599T"], "rxcui": ["403818"], "spl_set_id": ["f7c68d49-8c61-4bde-a880-4d78568e5aa0"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70069-081-01)  / 3 mL in 1 BOTTLE", "package_ndc": "70069-081-01", "marketing_start_date": "20241125"}], "brand_name": "Moxifloxacin Hydrochloride", "product_id": "70069-081_1a4f432a-c2b2-46bc-88fc-7379c2bbd0a2", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "70069-081", "generic_name": "Moxifloxacin Hydrochloride", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Moxifloxacin Hydrochloride", "active_ingredients": [{"name": "MOXIFLOXACIN HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA209698", "marketing_category": "ANDA", "marketing_start_date": "20241125", "listing_expiration_date": "20261231"}