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United States · US · US:83831-131_6e125601-ebbb-4fe6-9d9e-80d093b12532
AXTLE
In shortageOrange BookUNIISPLATC L01BA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAvyxa Pharma, LLC
CountryUS (United States)
ATC codeL01BA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1183831131011 VIAL in 1 CARTON (83831-131-01) / 4 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
04Q9AIZ7NO
PEMETREXED
RxCUI 68446
Orange Book
N210661
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Pemetrexed Ditromethamine Injection
Raw payload (JSON)
{
"unii": {
"unii": "04Q9AIZ7NO",
"rxcui": "68446",
"inchikey": "WBXPDJSOTKVWSJ-ZDUSSCGKSA-N",
"display_name": "PEMETREXED",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"9582c46c-d8b0-44b7-a2ee-9c86f5e9b7b1": {
"match": "brand_token",
"title": "AXTLE (PEMETREXED) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AVYXA PHARMA, LLC]",
"spl_version": "9",
"published_date": "2025-11-17"
}
},
"productid": "83831-131_6e125601-ebbb-4fe6-9d9e-80d093b12532",
"productndc": "83831-131",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "210661",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 100MG BASE/VIAL",
"product_no": "001",
"approval_date": "Jun 28, 2024"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 500MG BASE/VIAL",
"product_no": "002",
"approval_date": "Jun 28, 2024"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PEMETREXED",
"shortage_reason": "Pemetrexed Ditromethamine Injection",
"shortage_status": "current",
"proprietary_name": "AXTLE",
"active_ingred_unit": "mg/4mL",
"application_number": "NDA210661",
"marketing_category": "NDA",
"nonproprietary_name": "pemetrexed",
"start_marketing_date": "20250101",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code L01BA04.
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