🇺🇸
United States · US · US:64850-330_030a6bcf-d482-4c98-9d27-423235cdb930
Methotrexate Sodium
In shortageOrange BookUNIISPLATC L04AX03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerElite Laboratories, Inc.
CountryUS (United States)
ATC codeL04AX03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116485033001100 TABLET in 1 BOTTLE, PLASTIC (64850-330-01)
Annotations
UNII (FDA Substance ID)
3IG1E710ZN
METHOTREXATE SODIUM
RxCUI 287734
Orange Book
A216453
AB
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": "ORAL",
"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": "64850-330_030a6bcf-d482-4c98-9d27-423235cdb930",
"productndc": "64850-330",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "216453",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2.5MG BASE",
"product_no": "001",
"approval_date": "May 16, 2024"
}
],
"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 Sodium",
"active_ingred_unit": "mg/1",
"application_number": "ANDA216453",
"marketing_category": "ANDA",
"nonproprietary_name": "Methotrexate Sodium",
"start_marketing_date": "20240516",
"active_numerator_strength": "2.5"
}Related drugs
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