🇺🇸
United States · US · US:62049-286_8a24939c-6118-83ad-5a85-5277500bb20a
Cladribine
Orange BookUNIISPLATC L01BB04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGenvion Corporation
CountryUS (United States)
ATC codeL01BB04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 7
- ndc1162049286066 TABLET in 1 CARTON (62049-286-06)
- ndc1162049286077 TABLET in 1 CARTON (62049-286-07)
- ndc1162049286044 TABLET in 1 CARTON (62049-286-04)
- ndc1162049286055 TABLET in 1 CARTON (62049-286-05)
- ndc1162049286088 TABLET in 1 CARTON (62049-286-08)
- ndc1162049286099 TABLET in 1 CARTON (62049-286-09)
- ndc11620492861010 TABLET in 1 CARTON (62049-286-10)
Annotations
UNII (FDA Substance ID)
47M74X9YT5
CLADRIBINE
RxCUI 44157
Orange Book
A218425
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "47M74X9YT5",
"rxcui": "44157",
"inchikey": "PTOAARAWEBMLNO-KVQBGUIXSA-N",
"display_name": "CLADRIBINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"e0b363cb-db83-44d6-89d0-1f7176be7459": {
"match": "brand_token",
"title": "CLADRIBINE TABLET [SANDOZ INC.]",
"spl_version": "1",
"published_date": "2026-04-24"
}
},
"productid": "62049-286_8a24939c-6118-83ad-5a85-5277500bb20a",
"productndc": "62049-286",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "218425",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Nov 24, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CLADRIBINE",
"proprietary_name": "Cladribine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA218425",
"marketing_category": "ANDA",
"nonproprietary_name": "Cladribine",
"start_marketing_date": "20251125",
"active_numerator_strength": "10"
}Related drugs
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