fulvicin p/g 165 (69499-435)

Drug Facts

Product Profile

Brand Name fulvicin p/g 165

Generic Name ultramicrosize griseofulvin

Labeler solubiomix, llc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

griseofulvin 165 mg/1

Manufacturer

Solubiomix, LLC.

Identifiers & Regulatory

Product NDC 69499-435

Product ID 69499-435_2dcbcce9-a071-7c0c-e063-6294a90a029d

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA061996

Listing Expiration 2026-12-31

Marketing Start 1982-04-06

Pharmacologic Class

Established (EPC)

tubulin inhibiting agent [epc]

Physiologic Effect

decreased mitosis [pe] microtubule inhibition [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69499435

Hyphenated Format 69499-435

Supplemental Identifiers

RxCUI

92758 245248

UPC

0369499435305

UNII

32HRV3E3D5

NUI

N0000008732 N0000175085 N0000175848

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 fulvicin p/g 165 (source: ndc)

Generic Name ultramicrosize griseofulvin (source: ndc)

Application Number ANDA061996 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

165 mg/1

source: ndc

Packaging

30 TABLET in 1 BOTTLE (69499-435-30)

source: ndc

Packages (1)

69499-435-30 30 TABLET in 1 BOTTLE (69499-435-30)

Ingredients (1)

griseofulvin (165 mg/1)

Linked Drug Pages (1)

Fulvicin P/G 165 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "2dcbcce9-a071-7c0c-e063-6294a90a029d", "openfda": {"nui": ["N0000008732", "N0000175085", "N0000175848"], "upc": ["0369499435305"], "unii": ["32HRV3E3D5"], "rxcui": ["92758", "245248"], "spl_set_id": ["265a20de-8e20-4fc4-b4a3-e3738e5820b3"], "pharm_class_pe": ["Decreased Mitosis [PE]", "Microtubule Inhibition [PE]"], "pharm_class_epc": ["Tubulin Inhibiting Agent [EPC]"], "manufacturer_name": ["Solubiomix, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (69499-435-30)", "package_ndc": "69499-435-30", "marketing_start_date": "20250130"}], "brand_name": "Fulvicin P/G 165", "product_id": "69499-435_2dcbcce9-a071-7c0c-e063-6294a90a029d", "dosage_form": "TABLET", "pharm_class": ["Decreased Mitosis [PE]", "Microtubule Inhibition [PE]", "Tubulin Inhibiting Agent [EPC]"], "product_ndc": "69499-435", "generic_name": "ULTRAMICROSIZE GRISEOFULVIN", "labeler_name": "Solubiomix, LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fulvicin P/G 165", "active_ingredients": [{"name": "GRISEOFULVIN", "strength": "165 mg/1"}], "application_number": "ANDA061996", "marketing_category": "ANDA", "marketing_start_date": "19820406", "listing_expiration_date": "20261231"}