🇺🇸
United States · US · US:0703-3678_e81074cc-12b4-4ac9-a5bb-749188989b2c
Methotrexate
In shortageOrange BookUNIISPLATC L04AX03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Parenteral Medicines, Inc.
CountryUS (United States)
ATC codeL04AX03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1107033678011 VIAL, SINGLE-DOSE in 1 CARTON (0703-3678-01) / 40 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
3IG1E710ZN
METHOTREXATE SODIUM
RxCUI 287734
Orange Book
A040843
APAPAPAP
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; INTRATHECAL; 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": "0703-3678_e81074cc-12b4-4ac9-a5bb-749188989b2c",
"productndc": "0703-3678",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "040843",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 1GM BASE/40ML (EQ 25MG BASE/ML)",
"product_no": "001",
"approval_date": "Jan 11, 2010"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 50MG BASE/2ML (EQ 25MG BASE/ML)",
"product_no": "002",
"approval_date": "Jan 11, 2010"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 100MG BASE/4ML (EQ 25MG BASE/ML)",
"product_no": "003",
"approval_date": "Feb 27, 2012"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 250MG BASE/10ML (EQ 25MG BASE/ML)",
"product_no": "004",
"approval_date": "Jan 11, 2010"
}
],
"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": "ANDA040843",
"marketing_category": "ANDA",
"nonproprietary_name": "Methotrexate",
"start_marketing_date": "20120801",
"active_numerator_strength": "25"
}Related drugs
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- CAAURO-METHOTREXATEAURO PHARMA INC
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