ultramicrosize griseofulvin

Generic: ultramicrosize griseofulvin

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ultramicrosize griseofulvin
Generic Name ultramicrosize griseofulvin
Labeler sandoz inc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

griseofulvin 125 mg/1

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-5827
Product ID 0781-5827_6d66c19d-0069-4a47-a45c-567aa0398135
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202805
Listing Expiration 2026-12-31
Marketing Start 2020-04-01

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 07815827
Hyphenated Format 0781-5827

Supplemental Identifiers

RxCUI
239239 242831
UPC
0307815828011 0307815827014
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 ANDA202805 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/1
source: ndc
Packaging
  • 100 TABLET, COATED in 1 BOTTLE (0781-5827-01)
  • 500 TABLET, COATED in 1 BOTTLE (0781-5827-05)
source: ndc

Packages (2)

0781-5827-01 100 TABLET, COATED in 1 BOTTLE (0781-5827-01) 0781-5827-05 500 TABLET, COATED in 1 BOTTLE (0781-5827-05)

Ingredients (1)

griseofulvin (125 mg/1)

Linked Drug Pages (1)

Ultramicrosize Griseofulvin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6d66c19d-0069-4a47-a45c-567aa0398135", "openfda": {"nui": ["N0000008732", "N0000175085", "N0000175848"], "upc": ["0307815828011", "0307815827014"], "unii": ["32HRV3E3D5"], "rxcui": ["239239", "242831"], "spl_set_id": ["f4fa0eb9-bd6a-4ea2-b565-e0db88aa1ebd"], "pharm_class_pe": ["Decreased Mitosis [PE]", "Microtubule Inhibition [PE]"], "pharm_class_epc": ["Tubulin Inhibiting Agent [EPC]"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (0781-5827-01)", "package_ndc": "0781-5827-01", "marketing_start_date": "20200401"}, {"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE (0781-5827-05)", "package_ndc": "0781-5827-05", "marketing_start_date": "20200401"}], "brand_name": "Ultramicrosize Griseofulvin", "product_id": "0781-5827_6d66c19d-0069-4a47-a45c-567aa0398135", "dosage_form": "TABLET, COATED", "pharm_class": ["Decreased Mitosis [PE]", "Microtubule Inhibition [PE]", "Tubulin Inhibiting Agent [EPC]"], "product_ndc": "0781-5827", "generic_name": "Ultramicrosize Griseofulvin", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ultramicrosize Griseofulvin", "active_ingredients": [{"name": "GRISEOFULVIN", "strength": "125 mg/1"}], "application_number": "ANDA202805", "marketing_category": "ANDA", "marketing_start_date": "20200401", "listing_expiration_date": "20261231"}