🇺🇸
United States · US · US:16729-486_52d366f6-f339-ff1a-e063-6294a90a1577
Methotrexate
In shortageOrange BookUNIISPLATC L04AX03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAccord Healthcare Inc.
CountryUS (United States)
ATC codeL04AX03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc111672948601100 TABLET in 1 BOTTLE (16729-486-01)
Annotations
UNII (FDA Substance ID)
3IG1E710ZN
METHOTREXATE SODIUM
RxCUI 287734
Orange Book
A213343
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Methotrexate Sodium 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": "16729-486_52d366f6-f339-ff1a-e063-6294a90a1577",
"productndc": "16729-486",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "213343",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2.5MG BASE",
"product_no": "001",
"approval_date": "Jan 24, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "METHOTREXATE SODIUM",
"shortage_reason": "Methotrexate Sodium Injection",
"shortage_status": "current",
"proprietary_name": "Methotrexate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA213343",
"marketing_category": "ANDA",
"nonproprietary_name": "Methotrexate",
"start_marketing_date": "20200824",
"active_numerator_strength": "2.5"
}Related drugs
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- CAAURO-METHOTREXATEAURO PHARMA INC
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