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United States · US · US:0472-0013_ffdfb856-e4f1-41de-837b-a773b1f6eaf9
Griseofulvin
Orange BookUNIISPLATC D01AA08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeD01AA08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110472001304120 mL in 1 BOTTLE (0472-0013-04)
Annotations
UNII (FDA Substance ID)
32HRV3E3D5
GRISEOFULVIN
RxCUI 5021
Orange Book
A065394
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": "0472-0013_ffdfb856-e4f1-41de-837b-a773b1f6eaf9",
"productndc": "0472-0013",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "065394",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "125MG/5ML",
"product_no": "001",
"approval_date": "Jul 6, 2007"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GRISEOFULVIN",
"proprietary_name": "Griseofulvin",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA065394",
"marketing_category": "ANDA",
"nonproprietary_name": "Griseofulvin",
"start_marketing_date": "20070726",
"active_numerator_strength": "125"
}Related drugs
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