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United States · US · US:65219-552_510bc71b-20e4-428a-8fc2-29c9fc20f2f3
Pralatrexate
Orange BookUNIISPLATC L01BA05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeL01BA05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1165219552021 VIAL, SINGLE-DOSE in 1 CARTON (65219-552-02) / 2 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
A8Q8I19Q20
PRALATREXATE
RxCUI 662019
Orange Book
N022468
APAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "A8Q8I19Q20",
"rxcui": "662019",
"inchikey": "OGSBUKJUDHAQEA-WMCAAGNKSA-N",
"display_name": "PRALATREXATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"cc3df863-c51c-49c5-283a-d6808fb49258": {
"match": "brand_token",
"title": "PRALATREXATE INJECTION [DR.REDDY'S LABORATORIES INC.,]",
"spl_version": "6",
"published_date": "2026-03-05"
}
},
"productid": "65219-552_510bc71b-20e4-428a-8fc2-29c9fc20f2f3",
"productndc": "65219-552",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "022468",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AP",
"strength": "20MG/ML (20MG/ML)",
"product_no": "001",
"approval_date": "Sep 24, 2009"
},
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "40MG/2ML (20MG/ML)",
"product_no": "002",
"approval_date": "Sep 24, 2009"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PRALATREXATE",
"proprietary_name": "Pralatrexate",
"active_ingred_unit": "mg/2mL",
"application_number": "NDA022468",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "Pralatrexate",
"start_marketing_date": "20221115",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code L01BA05.
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