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United States · US · US:0054-0383_35c0ebb6-6127-4e3a-9846-4ad17f7d5cd4
Cyclophosphamide
Orange BookUNIISPLATC L01AA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeL01AA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110054038325100 CAPSULE in 1 BOTTLE (0054-0383-25)
Annotations
UNII (FDA Substance ID)
8N3DW7272P
CYCLOPHOSPHAMIDE
RxCUI 3002
Orange Book
N203856
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "8N3DW7272P",
"rxcui": "3002",
"inchikey": "PWOQRKCAHTVFLB-UHFFFAOYSA-N",
"display_name": "CYCLOPHOSPHAMIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"34dbffee-80e0-49c3-90e8-95713a0b7fbe": {
"match": "brand_token",
"title": "CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE INJECTION, SOLUTION) INJECTION [BAXTER HEALTHCARE COMPANY]",
"spl_version": "3",
"published_date": "2026-06-01"
}
},
"productid": "0054-0383_35c0ebb6-6127-4e3a-9846-4ad17f7d5cd4",
"productndc": "0054-0383",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "203856",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "25MG",
"product_no": "001",
"approval_date": "Sep 16, 2013"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "50MG",
"product_no": "002",
"approval_date": "Sep 16, 2013"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CYCLOPHOSPHAMIDE",
"proprietary_name": "Cyclophosphamide",
"active_ingred_unit": "mg/1",
"application_number": "NDA203856",
"marketing_category": "NDA",
"nonproprietary_name": "Cyclophosphamide",
"start_marketing_date": "20130916",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code L01AA01.
- BECyclofosfamide Accord 1000 mgAccord Healthcare
- NLCyclofosfamide Accord 1000 mg, poeder voor oplossing voor injectie / infusieAccord Healthcare B.V.
- BECyclofosfamide Accord 200 mg/mlAccord Healthcare
- BECyclofosfamide Accord 200 mg/mlAccord Healthcare
- BECyclofosfamide Accord 200 mg/mlAccord Healthcare
- BECyclofosfamide Accord 200 mg/mlAccord Healthcare
- NLCyclofosfamide Accord 2000 mg, poeder voor oplossing voor injectie / infusieAccord Healthcare B.V.
- BECyclofosfamide Accord 500 mgAccord Healthcare
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