🇺🇸
United States · US · US:25021-185_696f706f-39d7-4647-a506-2ebf7b956cc1
ganciclovir
Orange BookUNIISPLATC S01AD09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSagent Pharmaceuticals
CountryUS (United States)
ATC codeS01AD09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11250211851025 VIAL in 1 CARTON (25021-185-10) / 10 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
02L083W284
GANCICLOVIR SODIUM
RxCUI 82131
Orange Book
A207645
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "02L083W284",
"rxcui": "82131",
"inchikey": "JJICLMJFIKGAAU-UHFFFAOYSA-M",
"display_name": "GANCICLOVIR SODIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"35addab5-09db-4f8a-9c69-6fbce33ecc37": {
"match": "brand_token",
"title": "GANCICLOVIR (GANCICLOVIR SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]",
"spl_version": "6",
"published_date": "2026-02-12"
}
},
"productid": "25021-185_696f706f-39d7-4647-a506-2ebf7b956cc1",
"productndc": "25021-185",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "207645",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "EQ 500MG BASE/VIAL",
"product_no": "001",
"approval_date": "Dec 8, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GANCICLOVIR SODIUM",
"proprietary_name": "ganciclovir",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA207645",
"marketing_category": "ANDA",
"nonproprietary_name": "ganciclovir sodium",
"start_marketing_date": "20180215",
"active_numerator_strength": "50"
}Related drugs
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