🇺🇸
United States · US · US:46708-711_e98b2abd-8068-482e-9ce3-1ab262f0838e
METHOTREXATE
In shortageOrange BookUNIISPLATC L04AX03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Limited
CountryUS (United States)
ATC codeL04AX03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1146708711055 VIAL, MULTI-DOSE in 1 CARTON (46708-711-05) / 2 mL in 1 VIAL, MULTI-DOSE (46708-711-01)
Annotations
UNII (FDA Substance ID)
3IG1E710ZN
METHOTREXATE SODIUM
RxCUI 287734
Orange Book
A220225
APAP
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": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"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": "46708-711_e98b2abd-8068-482e-9ce3-1ab262f0838e",
"productndc": "46708-711",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "220225",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 50MG BASE/2ML (EQ 25MG BASE/ML)",
"product_no": "001",
"approval_date": "Apr 15, 2026"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 1GM BASE/40ML (EQ 25MG BASE/ML)",
"product_no": "002",
"approval_date": "Apr 15, 2026"
}
],
"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": "ANDA220225",
"marketing_category": "ANDA",
"nonproprietary_name": "methotrexate",
"start_marketing_date": "20260415",
"active_numerator_strength": "25"
}Related drugs
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- CAAURO-METHOTREXATEAURO PHARMA INC
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