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United States · US · US:14335-472_2aca7731-9fcc-4625-e063-6394a90a6020
Cyclophosphamide
Orange BookUNIISPLATC L01AA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHainan Poly Pharm. Co., Ltd.
CountryUS (United States)
ATC codeL01AA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1114335472101 VIAL, SINGLE-DOSE in 1 CARTON (14335-472-10) / 100 mL in 1 VIAL, SINGLE-DOSE (14335-472-01)
Annotations
UNII (FDA Substance ID)
8N3DW7272P
CYCLOPHOSPHAMIDE
RxCUI 3002
Orange Book
A218632
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": "INTRAVENOUS",
"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": "14335-472_2aca7731-9fcc-4625-e063-6394a90a6020",
"productndc": "14335-472",
"dosage_form": "INJECTION, POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "218632",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "500MG/VIAL",
"product_no": "001",
"approval_date": "Dec 26, 2024"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "1GM/VIAL",
"product_no": "002",
"approval_date": "Dec 26, 2024"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "2GM/VIAL",
"product_no": "003",
"approval_date": "Dec 26, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CYCLOPHOSPHAMIDE",
"proprietary_name": "Cyclophosphamide",
"active_ingred_unit": "g/100mL",
"application_number": "ANDA218632",
"marketing_category": "ANDA",
"nonproprietary_name": "Cyclophosphamide for Injection",
"start_marketing_date": "20250103",
"active_numerator_strength": "2"
}Related drugs
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- 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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