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United States · US · US:68001-564_3bc6345d-4340-1f0f-e063-6294a90ac0a9
CYCLOPHOSPHAMIDE
Orange BookUNIISPLATC L01AA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBluePoint Laboratories
CountryUS (United States)
ATC codeL01AA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168001564221 VIAL in 1 CARTON (68001-564-22) / 5 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
6UXW23996M
CYCLOPHOSPHAMIDE ANHYDROUS
RxCUI 1545988
Orange Book
N212501
APAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "6UXW23996M",
"rxcui": "1545988",
"inchikey": "CMSMOCZEIVJLDB-UHFFFAOYSA-N",
"display_name": "CYCLOPHOSPHAMIDE ANHYDROUS",
"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": "68001-564_3bc6345d-4340-1f0f-e063-6294a90ac0a9",
"productndc": "68001-564",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "212501",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "500MG/2.5ML (200MG/ML)",
"product_no": "001",
"approval_date": "Jul 30, 2020"
},
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "1GM/5ML (200MG/ML)",
"product_no": "002",
"approval_date": "Jul 30, 2020"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "2GM/10ML (200MG/ML)",
"product_no": "003",
"approval_date": "Nov 19, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CYCLOPHOSPHAMIDE ANHYDROUS",
"proprietary_name": "CYCLOPHOSPHAMIDE",
"active_ingred_unit": "mg/mL",
"application_number": "NDA212501",
"marketing_category": "NDA",
"nonproprietary_name": "cyclophosphamide",
"start_marketing_date": "20230410",
"active_numerator_strength": "200"
}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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