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United States · US · US:63323-122_3d21237a-ef53-4592-bf06-0c739696203d
Methotrexate
In shortageOrange BookUNIISPLATC L04AX03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeL04AX03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1163323122501 VIAL in 1 CARTON (63323-122-50) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
Annotations
UNII (FDA Substance ID)
3IG1E710ZN
METHOTREXATE SODIUM
RxCUI 287734
Orange Book
A040266
AP
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": "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": "63323-122_3d21237a-ef53-4592-bf06-0c739696203d",
"productndc": "63323-122",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "040266",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 1GM BASE/VIAL",
"product_no": "001",
"approval_date": "Feb 26, 1999"
}
],
"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": "g/1",
"application_number": "ANDA040266",
"marketing_category": "ANDA",
"nonproprietary_name": "METHOTREXATE SODIUM",
"start_marketing_date": "20000122",
"active_numerator_strength": "1"
}Related drugs
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- CAAURO-METHOTREXATEAURO PHARMA INC
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