moxifloxacin hydrochloride tablets, 400 mg

Generic: moxifloxacin hydrochloride tablets, 400 mg

Labeler: pd-rx pharmaceuticals, inc.
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 pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

moxifloxacin hydrochloride monohydrate 400 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-080
Product ID 72789-080_40319333-cf76-1664-e063-6294a90ae7e8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208682
Listing Expiration 2026-12-31
Marketing Start 2018-07-21

Pharmacologic Class

Classes
fluoroquinolone antibacterial [epc] fluoroquinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72789080
Hyphenated Format 72789-080

Supplemental Identifiers

RxCUI
311787
UPC
0372789080109
UNII
B8956S8609

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
  • 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-080-10)
source: ndc

Packages (1)

72789-080-10 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-080-10)

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": "40319333-cf76-1664-e063-6294a90ae7e8", "openfda": {"upc": ["0372789080109"], "unii": ["B8956S8609"], "rxcui": ["311787"], "spl_set_id": ["5c2a9116-d6e4-429e-88bb-bb6bfedac2f0"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-080-10)", "package_ndc": "72789-080-10", "marketing_start_date": "20200410"}], "brand_name": "Moxifloxacin Hydrochloride Tablets, 400 mg", "product_id": "72789-080_40319333-cf76-1664-e063-6294a90ae7e8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "72789-080", "generic_name": "Moxifloxacin Hydrochloride Tablets, 400 mg", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "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"}