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United States · US · US:51285-369_f8b23801-fcb1-4c68-9f7c-82dd8ba496ea
Trexall
In shortageOrange BookUNIISPLATC L04AX03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Women's Health LLC
CountryUS (United States)
ATC codeL04AX03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11512853690130 TABLET, FILM COATED in 1 BOTTLE (51285-369-01)
Annotations
UNII (FDA Substance ID)
3IG1E710ZN
METHOTREXATE SODIUM
RxCUI 287734
Orange Book
A040385
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": {
"e942f8db-510f-44d6-acb5-b822196f5e8c": {
"match": "brand_token",
"title": "TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH LLC]",
"spl_version": "13",
"published_date": "2026-06-02"
}
},
"productid": "51285-369_f8b23801-fcb1-4c68-9f7c-82dd8ba496ea",
"productndc": "51285-369",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "040385",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 5MG BASE",
"product_no": "001",
"approval_date": "Mar 21, 2001"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 7.5MG BASE",
"product_no": "002",
"approval_date": "Mar 21, 2001"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 10MG BASE",
"product_no": "003",
"approval_date": "Mar 21, 2001"
},
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "EQ 15MG BASE",
"product_no": "004",
"approval_date": "Mar 21, 2001"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "METHOTREXATE SODIUM",
"shortage_reason": "Methotrexate Injection",
"shortage_status": "current",
"proprietary_name": "Trexall",
"active_ingred_unit": "mg/1",
"application_number": "ANDA040385",
"marketing_category": "ANDA",
"nonproprietary_name": "Methotrexate",
"start_marketing_date": "20010503",
"active_numerator_strength": "15"
}Related drugs
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