🇺🇸
United States · US · US:68382-775_5d9b7269-19d4-4d2c-b252-f3ff759dffa5
Methotrexate
In shortageOrange BookUNIISPLATC L04AX03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeL04AX03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc116838277501100 TABLET in 1 BOTTLE (68382-775-01)
- ndc116838277505500 TABLET in 1 BOTTLE (68382-775-05)
- ndc1168382775101000 TABLET in 1 BOTTLE (68382-775-10)
- ndc11683827751690 TABLET in 1 BOTTLE (68382-775-16)
- ndc11683827756036 TABLET in 1 BOTTLE (68382-775-60)
- ndc116838277577100 BLISTER PACK in 1 CARTON (68382-775-77) / 1 TABLET in 1 BLISTER PACK
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": "68382-775_5d9b7269-19d4-4d2c-b252-f3ff759dffa5",
"productndc": "68382-775",
"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
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.