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United States · US · US:60505-4791_f29f726e-f858-7aff-d874-b322d5ca860c
Cladribine
Orange BookUNIISPLATC L01BB04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerApotex Corp.
CountryUS (United States)
ATC codeL01BB04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 7
- ndc11605054791110 TABLET in 1 CARTON (60505-4791-1)
- ndc1160505479144 TABLET in 1 CARTON (60505-4791-4)
- ndc1160505479155 TABLET in 1 CARTON (60505-4791-5)
- ndc1160505479166 TABLET in 1 CARTON (60505-4791-6)
- ndc1160505479177 TABLET in 1 CARTON (60505-4791-7)
- ndc1160505479188 TABLET in 1 CARTON (60505-4791-8)
- ndc1160505479199 TABLET in 1 CARTON (60505-4791-9)
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": "60505-4791_f29f726e-f858-7aff-d874-b322d5ca860c",
"productndc": "60505-4791",
"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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