podofilox

Generic: podofilox

Labeler: padagis us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name podofilox
Generic Name podofilox
Labeler padagis us llc
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

podofilox 5 mg/mL

Manufacturer
Padagis US LLC

Identifiers & Regulatory

Product NDC 0574-0611
Product ID 0574-0611_e75d3f9f-dd11-4c3e-9e6e-3d9af2cd76da
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075600
Listing Expiration 2026-12-31
Marketing Start 2002-01-29

Pharmacologic Class

Physiologic Effect
decreased mitosis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05740611
Hyphenated Format 0574-0611

Supplemental Identifiers

RxCUI
582926
UNII
L36H50F353
NUI
N0000008732

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 podofilox (source: ndc)
Generic Name podofilox (source: ndc)
Application Number ANDA075600 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (0574-0611-05) / 3.5 mL in 1 BOTTLE, GLASS
source: ndc

Packages (1)

0574-0611-05 1 BOTTLE, GLASS in 1 CARTON (0574-0611-05) / 3.5 mL in 1 BOTTLE, GLASS

Ingredients (1)

podofilox (5 mg/mL)

Linked Drug Pages (1)

PODOFILOX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "e75d3f9f-dd11-4c3e-9e6e-3d9af2cd76da", "openfda": {"nui": ["N0000008732"], "unii": ["L36H50F353"], "rxcui": ["582926"], "spl_set_id": ["6af07697-5203-43e0-ba35-83683af851c3"], "pharm_class_pe": ["Decreased Mitosis [PE]"], "manufacturer_name": ["Padagis US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, GLASS in 1 CARTON (0574-0611-05)  / 3.5 mL in 1 BOTTLE, GLASS", "package_ndc": "0574-0611-05", "marketing_start_date": "20020129"}], "brand_name": "PODOFILOX", "product_id": "0574-0611_e75d3f9f-dd11-4c3e-9e6e-3d9af2cd76da", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Mitosis [PE]"], "product_ndc": "0574-0611", "generic_name": "PODOFILOX", "labeler_name": "Padagis US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PODOFILOX", "active_ingredients": [{"name": "PODOFILOX", "strength": "5 mg/mL"}], "application_number": "ANDA075600", "marketing_category": "ANDA", "marketing_start_date": "20020129", "listing_expiration_date": "20261231"}