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United States · US · US:0781-8201_4ff7cb90-f8cc-5804-e063-6394a90ac0a6
Cladribine
Orange BookUNIISPLATC L01BB04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSandoz Inc.
CountryUS (United States)
ATC codeL01BB04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 7
- ndc1107818201379 TABLET in 1 CARTON (0781-8201-37)
- ndc1107818201515 TABLET in 1 CARTON (0781-8201-51)
- ndc1107818201686 TABLET in 1 CARTON (0781-8201-68)
- ndc1107818201717 TABLET in 1 CARTON (0781-8201-71)
- ndc11078182018010 TABLET in 1 CARTON (0781-8201-80)
- ndc1107818201858 TABLET in 1 CARTON (0781-8201-85)
- ndc1107818201944 TABLET in 1 CARTON (0781-8201-94)
Annotations
UNII (FDA Substance ID)
47M74X9YT5
CLADRIBINE
RxCUI 44157
Orange Book
A215547
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": "0781-8201_4ff7cb90-f8cc-5804-e063-6394a90ac0a6",
"productndc": "0781-8201",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "215547",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Mar 27, 2026"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CLADRIBINE",
"proprietary_name": "Cladribine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA215547",
"marketing_category": "ANDA",
"nonproprietary_name": "Cladribine",
"start_marketing_date": "20260423",
"active_numerator_strength": "10"
}Related drugs
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