🇺🇸
United States · US · US:16729-277_2bae3cfe-7aa0-c14c-e063-6294a90a19f4
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 · 3
- ndc1116729277031 VIAL in 1 CARTON (16729-277-03) / 10 mL in 1 VIAL
- ndc1116729277301 VIAL in 1 CARTON (16729-277-30) / 2 mL in 1 VIAL
- ndc1116729277351 VIAL in 1 CARTON (16729-277-35) / 40 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
YL5FZ2Y5U1
METHOTREXATE
RxCUI 6851
Orange Book
A040716
AP
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": "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": "16729-277_2bae3cfe-7aa0-c14c-e063-6294a90a19f4",
"productndc": "16729-277",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "040716",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "EQ 1GM BASE/40ML (EQ 25MG BASE/ML)",
"product_no": "001",
"approval_date": "Apr 30, 2007"
}
],
"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/mL",
"application_number": "ANDA040716",
"marketing_category": "ANDA",
"nonproprietary_name": "Methotrexate",
"start_marketing_date": "20140307",
"active_numerator_strength": "25"
}Related drugs
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- CAAURO-METHOTREXATEAURO PHARMA INC
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