moxifloxacin hydrochloride tablets, 400 mg

Generic: moxifloxacin hydrochloride tablets, 400 mg

Labeler: novadoz pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name moxifloxacin hydrochloride tablets, 400 mg
Generic Name moxifloxacin hydrochloride tablets, 400 mg
Labeler novadoz pharmaceuticals llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

moxifloxacin hydrochloride monohydrate 400 mg/1

Manufacturer
Novadoz Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72205-001
Product ID 72205-001_79a88ea4-ddf4-4ee9-acc2-91047ce636d5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208682
Listing Expiration 2026-12-31
Marketing Start 2018-07-21

Pharmacologic Class

Classes
quinolone antimicrobial [epc] quinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72205001
Hyphenated Format 72205-001

Supplemental Identifiers

RxCUI
311787
UPC
0372205001312 0372205001053
UNII
B8956S8609

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 tablets, 400 mg (source: ndc)
Generic Name moxifloxacin hydrochloride tablets, 400 mg (source: ndc)
Application Number ANDA208682 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (72205-001-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (72205-001-30)
  • 50 BLISTER PACK in 1 CARTON (72205-001-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK (72205-001-11)
source: ndc

Packages (3)

72205-001-05 500 TABLET, FILM COATED in 1 BOTTLE (72205-001-05) 72205-001-30 30 TABLET, FILM COATED in 1 BOTTLE (72205-001-30) 72205-001-31 50 BLISTER PACK in 1 CARTON (72205-001-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK (72205-001-11)

Ingredients (1)

moxifloxacin hydrochloride monohydrate (400 mg/1)

Linked Drug Pages (1)

Moxifloxacin Hydrochloride Tablets, 400 mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "79a88ea4-ddf4-4ee9-acc2-91047ce636d5", "openfda": {"upc": ["0372205001312", "0372205001053"], "unii": ["B8956S8609"], "rxcui": ["311787"], "spl_set_id": ["04e0936f-2248-48e4-8031-ac6ccc2df294"], "manufacturer_name": ["Novadoz Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (72205-001-05)", "package_ndc": "72205-001-05", "marketing_start_date": "20190416"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72205-001-30)", "package_ndc": "72205-001-30", "marketing_start_date": "20190416"}, {"sample": false, "description": "50 BLISTER PACK in 1 CARTON (72205-001-31)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (72205-001-11)", "package_ndc": "72205-001-31", "marketing_start_date": "20190416"}], "brand_name": "Moxifloxacin Hydrochloride Tablets, 400 mg", "product_id": "72205-001_79a88ea4-ddf4-4ee9-acc2-91047ce636d5", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "72205-001", "generic_name": "Moxifloxacin Hydrochloride Tablets, 400 mg", "labeler_name": "Novadoz Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Moxifloxacin Hydrochloride Tablets, 400 mg", "active_ingredients": [{"name": "MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE", "strength": "400 mg/1"}], "application_number": "ANDA208682", "marketing_category": "ANDA", "marketing_start_date": "20180721", "listing_expiration_date": "20261231"}