🇺🇸
United States · US · US:48433-065_49a1fdee-5587-e05a-e063-6294a90aebc5
Methotrexate
In shortageOrange BookUNIISPLATC L04AX03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSafecor Health LLC
CountryUS (United States)
ATC codeL04AX03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11484330650520 BLISTER PACK in 1 CARTON (48433-065-05) / 1 TABLET in 1 BLISTER PACK (48433-065-01)
Annotations
UNII (FDA Substance ID)
3IG1E710ZN
METHOTREXATE SODIUM
RxCUI 287734
Orange Book
A081235
AB
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": {
"9b34b1d8-d125-41a2-9f6f-3fab67b573bd": {
"match": "brand_token",
"title": "METHOTREXATE TABLET [TEVA PHARMACEUTICALS USA, INC.]",
"spl_version": "16",
"published_date": "2026-06-02"
}
},
"productid": "48433-065_49a1fdee-5587-e05a-e063-6294a90aebc5",
"productndc": "48433-065",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "081235",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2.5MG BASE",
"product_no": "001",
"approval_date": "May 15, 1992"
}
],
"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/1",
"application_number": "ANDA081235",
"marketing_category": "ANDA",
"nonproprietary_name": "methotrexate",
"start_marketing_date": "20260119",
"active_numerator_strength": "2.5"
}Related drugs
Other records sharing ATC code L04AX03.
- 🇮🇹AFSLAMET*4 siringhe preriempite SC 10 mg 0,40 mlS.F. GROUP Srl
- 🇮🇹AFSLAMET*4 siringhe preriempite SC 12,5 mg 0,31 mlS.F. GROUP Srl
- 🇮🇹AFSLAMET*4 siringhe preriempite SC 15 mg 0,38 mlS.F. GROUP Srl
- 🇮🇹AFSLAMET*4 siringhe preriempite SC 17,5 mg 0,44 mlS.F. GROUP Srl
- 🇮🇹AFSLAMET*4 siringhe preriempite SC 20 mg 0,50 mlS.F. GROUP Srl
- 🇮🇹AFSLAMET*4 siringhe preriempite SC 25 mg 0,63 mlS.F. GROUP Srl
- 🇮🇹AFSLAMET*4 siringhe preriempite SC 7,5 mg 0,30 mlS.F. GROUP Srl
- CAAURO-METHOTREXATEAURO PHARMA INC
Access this data programmatically
Query Methotrexate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.