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United States · US · US:43598-342_b885a7b3-a241-638d-8f27-d162c562469a
Pralatrexate
Orange BookUNIISPLATC L01BA05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr.Reddy's Laboratories Inc.,
CountryUS (United States)
ATC codeL01BA05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1143598342111 VIAL, SINGLE-DOSE in 1 CARTON (43598-342-11) / 1 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
A8Q8I19Q20
PRALATREXATE
RxCUI 662019
Orange Book
A206183
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": "43598-342_b885a7b3-a241-638d-8f27-d162c562469a",
"productndc": "43598-342",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "206183",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "20MG/ML (20MG/ML)",
"product_no": "001",
"approval_date": "Mar 10, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "40MG/2ML (20MG/ML)",
"product_no": "002",
"approval_date": "Mar 10, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PRALATREXATE",
"proprietary_name": "Pralatrexate",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA206183",
"marketing_category": "ANDA",
"nonproprietary_name": "Pralatrexate",
"start_marketing_date": "20260304",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code L01BA05.
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