🇺🇸
United States · US · US:63323-315_41a1504e-f02c-4ec1-9650-709e945234eb
Ganciclovir
Orange BookUNIISPLATC S01AD09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeS01AD09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11633233151025 VIAL in 1 TRAY (63323-315-10) / 10 mL in 1 VIAL (63323-315-01)
Annotations
UNII (FDA Substance ID)
02L083W284
GANCICLOVIR SODIUM
RxCUI 82131
Orange Book
A090658
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": "63323-315_41a1504e-f02c-4ec1-9650-709e945234eb",
"productndc": "63323-315",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "090658",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 500MG BASE/VIAL",
"product_no": "001",
"approval_date": "Jun 21, 2010"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GANCICLOVIR SODIUM",
"proprietary_name": "Ganciclovir",
"active_ingred_unit": "mg/10mL",
"application_number": "ANDA090658",
"marketing_category": "ANDA",
"nonproprietary_name": "GANCICLOVIR SODIUM",
"start_marketing_date": "20100628",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code S01AD09.
- GBCymevene 250mg capsulesRoche Products Ltd
- 🇪🇸CYMEVENE 500 mg POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSIONCheplapharm Arzneimittel Gmbh
- GBCymevene 500mg capsulesRoche Products Ltd
- GBCymevene 500mg powder for concentrate for solution for infusion vialsNeon Healthcare Ltd
- CAEYEZIRGANLABORATOIRES THEA
- 🇺🇸ganciclovirSagent Pharmaceuticals
- 🇺🇸ganciclovirSlate Run Pharmaceuticals, LLC
- 🇺🇸GanciclovirFresenius Kabi USA, LLC
Access this data programmatically
Query Ganciclovir and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.