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United States · US · US:70121-1239_40ce8341-9b51-4187-920b-ad9cce7930e1
Cyclophosphamide
Orange BookUNIISPLATC L01AA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeL01AA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170121123911 VIAL, SINGLE-DOSE in 1 CARTON (70121-1239-1) / 50 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
8N3DW7272P
CYCLOPHOSPHAMIDE
RxCUI 3002
Orange Book
A210046
APAPAP
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; 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": "70121-1239_40ce8341-9b51-4187-920b-ad9cce7930e1",
"productndc": "70121-1239",
"dosage_form": "INJECTION, POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "210046",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "500MG/VIAL",
"product_no": "001",
"approval_date": "May 25, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "1GM/VIAL",
"product_no": "002",
"approval_date": "May 25, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "2GM/VIAL",
"product_no": "003",
"approval_date": "May 25, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CYCLOPHOSPHAMIDE",
"proprietary_name": "Cyclophosphamide",
"active_ingred_unit": "g/50mL",
"application_number": "ANDA210046",
"marketing_category": "ANDA",
"nonproprietary_name": "Cyclophosphamide",
"start_marketing_date": "20180531",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code L01AA01.
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- 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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