ultramicrosize griseofulvin

Generic: ultramicrosize griseofulvin

Labeler: sigmapharm laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ultramicrosize griseofulvin
Generic Name ultramicrosize griseofulvin
Labeler sigmapharm laboratories, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

griseofulvin 125 mg/1

Manufacturer
Sigmapharm Laboratories, LLC

Identifiers & Regulatory

Product NDC 42794-013
Product ID 42794-013_d58d8124-4925-b8a1-e053-2995a90ac4c5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202545
Listing Expiration 2026-12-31
Marketing Start 2012-11-15

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 42794013
Hyphenated Format 42794-013

Supplemental Identifiers

RxCUI
239239 242831
UPC
0342794013089 0342794014086
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 ultramicrosize griseofulvin (source: ndc)
Generic Name ultramicrosize griseofulvin (source: ndc)
Application Number ANDA202545 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (42794-013-08)
source: ndc

Packages (1)

Ingredients (1)

griseofulvin (125 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "d58d8124-4925-b8a1-e053-2995a90ac4c5", "openfda": {"nui": ["N0000008732", "N0000175085", "N0000175848"], "upc": ["0342794013089", "0342794014086"], "unii": ["32HRV3E3D5"], "rxcui": ["239239", "242831"], "spl_set_id": ["37b4d132-84f1-4394-b468-7e74eeec61eb"], "pharm_class_pe": ["Decreased Mitosis [PE]", "Microtubule Inhibition [PE]"], "pharm_class_epc": ["Tubulin Inhibiting Agent [EPC]"], "manufacturer_name": ["Sigmapharm Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (42794-013-08)", "package_ndc": "42794-013-08", "marketing_start_date": "20160511"}], "brand_name": "Ultramicrosize Griseofulvin", "product_id": "42794-013_d58d8124-4925-b8a1-e053-2995a90ac4c5", "dosage_form": "TABLET", "pharm_class": ["Decreased Mitosis [PE]", "Microtubule Inhibition [PE]", "Tubulin Inhibiting Agent [EPC]"], "product_ndc": "42794-013", "generic_name": "Ultramicrosize Griseofulvin", "labeler_name": "Sigmapharm Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ultramicrosize Griseofulvin", "active_ingredients": [{"name": "GRISEOFULVIN", "strength": "125 mg/1"}], "application_number": "ANDA202545", "marketing_category": "ANDA", "marketing_start_date": "20121115", "listing_expiration_date": "20261231"}