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United States · US · US:69097-361_6cf78fd3-5be6-412c-acdf-f599efaf0654
grisofulvin
Orange BookUNIISPLATC D01AA08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCipla USA Inc.
CountryUS (United States)
ATC codeD01AA08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116909736108120 mL in 1 BOTTLE (69097-361-08)
Annotations
UNII (FDA Substance ID)
32HRV3E3D5
GRISEOFULVIN
RxCUI 5021
Orange Book
A065354
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": {
"d5c737e5-51b8-4322-a2a5-4d4a392c1f56": {
"match": "brand_token",
"title": "GRISOFULVIN SUSPENSION [CIPLA USA INC.]",
"spl_version": "6",
"published_date": "2024-03-28"
}
},
"productid": "69097-361_6cf78fd3-5be6-412c-acdf-f599efaf0654",
"productndc": "69097-361",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "065354",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "125MG/5ML",
"product_no": "001",
"approval_date": "Sep 10, 2007"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GRISEOFULVIN",
"proprietary_name": "grisofulvin",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA065354",
"marketing_category": "ANDA",
"nonproprietary_name": "grisofulvin",
"start_marketing_date": "20170306",
"active_numerator_strength": "125"
}Related drugs
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