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United States · US · US:68083-337_b913ae17-4b11-4748-a883-eba1bc9e9c06
Cytarabine
Orange BookUNIISPLATC L01BC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGland Pharma Limited
CountryUS (United States)
ATC codeL01BC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168083337011 VIAL, SINGLE-DOSE in 1 CARTON (68083-337-01) / 20 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
04079A1RDZ
CYTARABINE
RxCUI 3041
Orange Book
A211938
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "04079A1RDZ",
"rxcui": "3041",
"inchikey": "UHDGCWIWMRVCDJ-CCXZUQQUSA-N",
"display_name": "CYTARABINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS",
"spl_meta": {
"277597b0-7d85-40a3-a34a-70c6a883fc6d": {
"match": "brand_token",
"title": "CYTARABINE INJECTION, SOLUTION [HOSPIRA, INC.]",
"spl_version": "13",
"published_date": "2025-09-01"
}
},
"productid": "68083-337_b913ae17-4b11-4748-a883-eba1bc9e9c06",
"productndc": "68083-337",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "211938",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "2GM/VIAL",
"product_no": "001",
"approval_date": "Dec 23, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CYTARABINE",
"proprietary_name": "Cytarabine",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA211938",
"marketing_category": "ANDA",
"nonproprietary_name": "Cytarabine",
"start_marketing_date": "20191223",
"active_numerator_strength": "100"
}Related drugs
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