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United States · US · US:0143-9299_192fd7cc-3a38-4afe-82f3-a4d89238b1ad
Ganciclovir
Orange BookUNIISPLATC S01AD09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeS01AD09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11014392991010 VIAL in 1 BOX (0143-9299-10) / 10 mL in 1 VIAL (0143-9299-01)
Annotations
UNII (FDA Substance ID)
02L083W284
GANCICLOVIR SODIUM
RxCUI 82131
Orange Book
A076222
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": "0143-9299_192fd7cc-3a38-4afe-82f3-a4d89238b1ad",
"productndc": "0143-9299",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "076222",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 500MG BASE/VIAL",
"product_no": "001",
"approval_date": "Jul 16, 2003"
}
],
"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": "ANDA076222",
"marketing_category": "ANDA",
"nonproprietary_name": "Ganciclovir sodium",
"start_marketing_date": "20210617",
"active_numerator_strength": "50"
}Related drugs
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