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United States · US · US:82959-111_b96b0022-c4f5-458e-aa7e-21c62ac5cd8c
RYTELO
Orange BookUNIISPLATC L01XX80
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGeron Corporation
CountryUS (United States)
ATC codeL01XX80
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1182959111011 VIAL, SINGLE-DOSE in 1 CARTON (82959-111-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
2AW48LAZ4I
IMETELSTAT SODIUM
Orange Book
N217779
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "2AW48LAZ4I",
"rxcui": null,
"inchikey": "IEVORMRANFJJFR-NMZIRJKDSA-A",
"display_name": "IMETELSTAT SODIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"b0fab7ca-e578-43c5-9df6-bdaff4182257": {
"match": "brand_token",
"title": "RYTELO (IMETELSTAT SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GERON CORPORATION]",
"spl_version": "4",
"published_date": "2026-04-27"
}
},
"productid": "82959-111_b96b0022-c4f5-458e-aa7e-21c62ac5cd8c",
"productndc": "82959-111",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "217779",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 47MG BASE/VIAL",
"product_no": "001",
"approval_date": "Jun 6, 2024"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 188MG BASE/VIAL",
"product_no": "002",
"approval_date": "Jun 6, 2024"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IMETELSTAT SODIUM",
"proprietary_name": "RYTELO",
"active_ingred_unit": "mg/1",
"application_number": "NDA217779",
"marketing_category": "NDA",
"nonproprietary_name": "imetelstat sodium",
"start_marketing_date": "20240606",
"active_numerator_strength": "188"
}Related drugs
Other records sharing ATC code L01XX80.
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