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 GEL
Routes
TOPICAL
Active Ingredients

podofilox 5 mg/g

Manufacturer
Padagis US LLC

Identifiers & Regulatory

Product NDC 0574-0621
Product ID 0574-0621_d2e70c5e-d4a9-4295-9eff-517ffb974e61
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211871
Listing Expiration 2026-12-31
Marketing Start 2023-12-13

Pharmacologic Class

Physiologic Effect
decreased mitosis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05740621
Hyphenated Format 0574-0621

Supplemental Identifiers

RxCUI
312466
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 ANDA211871 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/g
source: ndc
Packaging
  • 3.5 g in 1 TUBE, WITH APPLICATOR (0574-0621-05)
source: ndc

Packages (1)

0574-0621-05 3.5 g in 1 TUBE, WITH APPLICATOR (0574-0621-05)

Ingredients (1)

podofilox (5 mg/g)

Linked Drug Pages (1)

Podofilox ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "d2e70c5e-d4a9-4295-9eff-517ffb974e61", "openfda": {"nui": ["N0000008732"], "unii": ["L36H50F353"], "rxcui": ["312466"], "spl_set_id": ["d2e70c5e-d4a9-4295-9eff-517ffb974e61"], "pharm_class_pe": ["Decreased Mitosis [PE]"], "manufacturer_name": ["Padagis US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3.5 g in 1 TUBE, WITH APPLICATOR (0574-0621-05)", "package_ndc": "0574-0621-05", "marketing_start_date": "20231213"}], "brand_name": "Podofilox", "product_id": "0574-0621_d2e70c5e-d4a9-4295-9eff-517ffb974e61", "dosage_form": "GEL", "pharm_class": ["Decreased Mitosis [PE]"], "product_ndc": "0574-0621", "generic_name": "Podofilox", "labeler_name": "Padagis US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Podofilox", "active_ingredients": [{"name": "PODOFILOX", "strength": "5 mg/g"}], "application_number": "ANDA211871", "marketing_category": "ANDA", "marketing_start_date": "20231213", "listing_expiration_date": "20261231"}