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United States · US · US:0713-0850_284eb653-b312-78e5-e063-6394a90a1e17
Griseofulvin
Orange BookUNIISPLATC D01AA08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCosette Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeD01AA08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110713085004118 mL in 1 BOTTLE, PLASTIC (0713-0850-04)
Annotations
UNII (FDA Substance ID)
32HRV3E3D5
GRISEOFULVIN
RxCUI 5021
Orange Book
A065438
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "32HRV3E3D5",
"rxcui": "5021",
"inchikey": "DDUHZTYCFQRHIY-RBHXEPJQSA-N",
"display_name": "GRISEOFULVIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"98829d90-b289-4bec-a625-7af412a5cb2d": {
"match": "brand_token",
"title": "GRISEOFULVIN TABLET [SANDOZ INC]",
"spl_version": "4",
"published_date": "2025-11-21"
}
},
"productid": "0713-0850_284eb653-b312-78e5-e063-6394a90a1e17",
"productndc": "0713-0850",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "065438",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "125MG/5ML",
"product_no": "001",
"approval_date": "Oct 8, 2010"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GRISEOFULVIN",
"proprietary_name": "Griseofulvin",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA065438",
"marketing_category": "ANDA",
"nonproprietary_name": "Griseofulvin",
"start_marketing_date": "20221101",
"active_numerator_strength": "125"
}Related drugs
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- 🇺🇸GriseofulvinChartwell RX, LLC.
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