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United States · US · US:63323-123_880c2caa-1b11-45ce-a54e-a3733da367f0
Methotrexate
In shortageOrange BookUNIISPLATC L04AX03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeL04AX03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1163323123101 VIAL in 1 CARTON (63323-123-10) / 10 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
3IG1E710ZN
METHOTREXATE SODIUM
RxCUI 287734
Orange Book
A040263
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Methotrexate Injection
Raw payload (JSON)
{
"unii": {
"unii": "3IG1E710ZN",
"rxcui": "287734",
"inchikey": "DASQOOZCTWOQPA-GXKRWWSZSA-L",
"display_name": "METHOTREXATE SODIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRA-ARTERIAL; INTRAMUSCULAR; INTRAVENOUS",
"spl_meta": {
"9b34b1d8-d125-41a2-9f6f-3fab67b573bd": {
"match": "brand_token",
"title": "METHOTREXATE TABLET [TEVA PHARMACEUTICALS USA, INC.]",
"spl_version": "16",
"published_date": "2026-06-02"
}
},
"productid": "63323-123_880c2caa-1b11-45ce-a54e-a3733da367f0",
"productndc": "63323-123",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "040263",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "EQ 50MG BASE/2ML (EQ 25MG BASE/ML)",
"product_no": "001",
"approval_date": "Feb 26, 1999"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 250MG BASE/10ML (EQ 25MG BASE/ML)",
"product_no": "002",
"approval_date": "Feb 26, 1999"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "METHOTREXATE SODIUM",
"shortage_reason": "Methotrexate Injection",
"shortage_status": "current",
"proprietary_name": "Methotrexate",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA040263",
"marketing_category": "ANDA",
"nonproprietary_name": "METHOTREXATE SODIUM",
"start_marketing_date": "20010910",
"active_numerator_strength": "25"
}Related drugs
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- CAAURO-METHOTREXATEAURO PHARMA INC
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