moxifloxacin hydrochloride

Generic: moxifloxacin hydrochloride

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name moxifloxacin hydrochloride
Generic Name moxifloxacin hydrochloride
Labeler remedyrepack inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

moxifloxacin hydrochloride 400 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3738
Product ID 70518-3738_3f63002b-3ecc-2ca5-e063-6294a90a7c33
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202632
Listing Expiration 2026-12-31
Marketing Start 2023-05-30

Pharmacologic Class

Classes
fluoroquinolone antibacterial [epc] fluoroquinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705183738
Hyphenated Format 70518-3738

Supplemental Identifiers

RxCUI
311787
UNII
C53598599T

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 ANDA202632 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3738-0)
source: ndc

Packages (1)

70518-3738-0 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3738-0)

Ingredients (1)

moxifloxacin hydrochloride (400 mg/1)

Linked Drug Pages (1)

MOXIFLOXACIN HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3f63002b-3ecc-2ca5-e063-6294a90a7c33", "openfda": {"unii": ["C53598599T"], "rxcui": ["311787"], "spl_set_id": ["bd0c0690-ba48-41c5-b76b-b1a53c36f424"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3738-0)", "package_ndc": "70518-3738-0", "marketing_start_date": "20230530"}], "brand_name": "MOXIFLOXACIN HYDROCHLORIDE", "product_id": "70518-3738_3f63002b-3ecc-2ca5-e063-6294a90a7c33", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "70518-3738", "generic_name": "moxifloxacin hydrochloride", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MOXIFLOXACIN HYDROCHLORIDE", "active_ingredients": [{"name": "MOXIFLOXACIN HYDROCHLORIDE", "strength": "400 mg/1"}], "application_number": "ANDA202632", "marketing_category": "ANDA", "marketing_start_date": "20230530", "listing_expiration_date": "20261231"}