griseofulvin

Generic: griseofulvin

Labeler: cosette pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name griseofulvin
Generic Name griseofulvin
Labeler cosette pharmaceuticals, inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

griseofulvin 125 mg/5mL

Manufacturer
Cosette Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0713-0850
Product ID 0713-0850_284eb653-b312-78e5-e063-6394a90a1e17
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065438
Listing Expiration 2026-12-31
Marketing Start 2022-11-01

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 07130850
Hyphenated Format 0713-0850

Supplemental Identifiers

RxCUI
239238
UPC
0307130850049
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 griseofulvin (source: ndc)
Generic Name griseofulvin (source: ndc)
Application Number ANDA065438 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/5mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE, PLASTIC (0713-0850-04)
source: ndc

Packages (1)

0713-0850-04 118 mL in 1 BOTTLE, PLASTIC (0713-0850-04)

Ingredients (1)

griseofulvin (125 mg/5mL)

Linked Drug Pages (1)

Griseofulvin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "284eb653-b312-78e5-e063-6394a90a1e17", "openfda": {"nui": ["N0000008732", "N0000175085", "N0000175848"], "upc": ["0307130850049"], "unii": ["32HRV3E3D5"], "rxcui": ["239238"], "spl_set_id": ["67e3ba3c-77e1-43b5-a93c-5bf5e3855780"], "pharm_class_pe": ["Decreased Mitosis [PE]", "Microtubule Inhibition [PE]"], "pharm_class_epc": ["Tubulin Inhibiting Agent [EPC]"], "manufacturer_name": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE, PLASTIC (0713-0850-04)", "package_ndc": "0713-0850-04", "marketing_start_date": "20221101"}], "brand_name": "Griseofulvin", "product_id": "0713-0850_284eb653-b312-78e5-e063-6394a90a1e17", "dosage_form": "SUSPENSION", "pharm_class": ["Decreased Mitosis [PE]", "Microtubule Inhibition [PE]", "Tubulin Inhibiting Agent [EPC]"], "product_ndc": "0713-0850", "generic_name": "Griseofulvin", "labeler_name": "Cosette Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Griseofulvin", "active_ingredients": [{"name": "GRISEOFULVIN", "strength": "125 mg/5mL"}], "application_number": "ANDA065438", "marketing_category": "ANDA", "marketing_start_date": "20221101", "listing_expiration_date": "20261231"}