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United States · US · US:63323-140_77a36c8d-5dde-47a1-a50c-77239395cee2
Cladribine
Orange BookUNIISPLATC L01BB04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeL01BB04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1163323140101 VIAL, SINGLE-DOSE in 1 CARTON (63323-140-10) / 10 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
47M74X9YT5
CLADRIBINE
RxCUI 44157
Orange Book
A076571
AP
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": "INTRAVENOUS",
"spl_meta": {
"e0b363cb-db83-44d6-89d0-1f7176be7459": {
"match": "brand_token",
"title": "CLADRIBINE TABLET [SANDOZ INC.]",
"spl_version": "1",
"published_date": "2026-04-24"
}
},
"productid": "63323-140_77a36c8d-5dde-47a1-a50c-77239395cee2",
"productndc": "63323-140",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "076571",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "1MG/ML",
"product_no": "001",
"approval_date": "Apr 22, 2004"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CLADRIBINE",
"proprietary_name": "Cladribine",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA076571",
"marketing_category": "ANDA",
"nonproprietary_name": "CLADRIBINE",
"start_marketing_date": "20041201",
"active_numerator_strength": "1"
}Related drugs
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