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United States · US · US:70771-1058_ae399908-cfb6-44dc-83da-8981f5dabbb8
Methotrexate
In shortageOrange BookUNIISPLATC L04AX03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeL04AX03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc1170771105801000 TABLET in 1 BOTTLE (70771-1058-0)
- ndc117077110581100 TABLET in 1 BOTTLE (70771-1058-1)
- ndc11707711058336 TABLET in 1 BOTTLE (70771-1058-3)
- ndc117077110585500 TABLET in 1 BOTTLE (70771-1058-5)
- ndc117077110587100 BLISTER PACK in 1 CARTON (70771-1058-7) / 1 TABLET in 1 BLISTER PACK (70771-1058-2)
- ndc11707711058990 TABLET in 1 BOTTLE (70771-1058-9)
Annotations
UNII (FDA Substance ID)
YL5FZ2Y5U1
METHOTREXATE
RxCUI 6851
Orange Book
A207812
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Methotrexate Injection
Raw payload (JSON)
{
"unii": {
"unii": "YL5FZ2Y5U1",
"rxcui": "6851",
"inchikey": "FBOZXECLQNJBKD-ZDUSSCGKSA-N",
"display_name": "METHOTREXATE",
"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": "70771-1058_ae399908-cfb6-44dc-83da-8981f5dabbb8",
"productndc": "70771-1058",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "207812",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2.5MG BASE",
"product_no": "001",
"approval_date": "Jan 13, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "METHOTREXATE",
"shortage_reason": "Methotrexate Injection",
"shortage_status": "current",
"proprietary_name": "Methotrexate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA207812",
"marketing_category": "ANDA",
"nonproprietary_name": "Methotrexate",
"start_marketing_date": "20170209",
"active_numerator_strength": "2.5"
}Related drugs
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- CAAURO-METHOTREXATEAURO PHARMA INC
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