DEA schedule

Is methotrexate a controlled substance?

Federal schedule for methotrexate from the FDA NDC directory, checked against the DEA controlled substances list.

Source: FDA NDC Directory file dated 2026-10-22. Publisher page

No. Methotrexate is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and methotrexate is not on the DEA controlled substances list.

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Schedule check

Schedule sources for Methotrexate
SourceWhat it lists
FDA NDC directory78 prescription listings from 34 labelers, none with a DEA schedule
DEA controlled substances listmethotrexate is not on the list

Methotrexate NDC listings

NDC listings for Methotrexate
NDCProductFormStrengthLabelerDEA schedule
81927-204JYLAMVOsolution2 mg/mLSHORLA ONCOLOGY INC.None
61703-124Methotrexateinjection, solution25 mg/mLHospira, Inc.None
61703-161Methotrexateinjection, solution25 mg/mLHospira, Inc.None
61703-350Methotrexateinjection, solution25 mg/mLHospira, Inc.None
61703-350Methotrexateinjection, solution25 mg/mLHospira, Inc.None
61703-408Methotrexateinjection, solution25 mg/mLHospira, Inc.None
61703-408Methotrexateinjection, solution25 mg/mLHospira, Inc.None
54436-010Otrexupinjection, solution10 mg/.4mLAntares Pharma, Inc.None
54436-012Otrexupinjection, solution12.5 mg/.4mLAntares Pharma, Inc.None
54436-015Otrexupinjection, solution15 mg/.4mLAntares Pharma, Inc.None
54436-017Otrexupinjection, solution17.5 mg/.4mLAntares Pharma, Inc.None
54436-020Otrexupinjection, solution20 mg/.4mLAntares Pharma, Inc.None
54436-022Otrexupinjection, solution22.5 mg/.4mLAntares Pharma, Inc.None
54436-025Otrexupinjection, solution25 mg/.4mLAntares Pharma, Inc.None
59137-510Rasuvoinjection, solution10 mg/.2mLMedexus Pharma Inc.None
59137-515Rasuvoinjection, solution12.5 mg/.25mLMedexus Pharma Inc.None
59137-520Rasuvoinjection, solution15 mg/.3mLMedexus Pharma Inc.None
59137-525Rasuvoinjection, solution17.5 mg/.35mLMedexus Pharma Inc.None
59137-530Rasuvoinjection, solution20 mg/.4mLMedexus Pharma Inc.None
59137-535Rasuvoinjection, solution22.5 mg/.45mLMedexus Pharma Inc.None
59137-540Rasuvoinjection, solution25 mg/.5mLMedexus Pharma Inc.None
59137-550Rasuvoinjection, solution30 mg/.6mLMedexus Pharma Inc.None
59137-505Rasuvoinjection, solution7.5 mg/.15mLMedexus Pharma Inc.None
52652-2001Xatmepsolution2.5 mg/mLAzurity Pharmaceuticals, Inc.None
16729-277Methotrexateinjection25 mg/mLAccord Healthcare, Inc.None
0143-9367Methotrexateinjection, powder, lyophilized, for solution1 g/1Hikma Pharmaceuticals USA Inc.None
0143-9830Methotrexateinjection, powder, lyophilized, for solution1 g/1Hikma Pharmaceuticals USA Inc.None
63323-122Methotrexateinjection, powder, lyophilized, for solution1 g/1Fresenius Kabi USA, LLCNone
55150-511METHOTREXATEinjection, solution100 mg/4mLEugia US LLCNone
55150-512METHOTREXATEinjection, solution200 mg/8mLEugia US LLCNone
0703-3671Methotrexateinjection, solution25 mg/mLTeva Parenteral Medicines, Inc.None
0703-3675Methotrexateinjection, solution25 mg/mLTeva Parenteral Medicines, Inc.None
0703-3678Methotrexateinjection, solution25 mg/mLTeva Parenteral Medicines, Inc.None
46708-711METHOTREXATEinjection, solution25 mg/mLAlembic Pharmaceuticals LimitedNone
46708-712METHOTREXATEinjection, solution25 mg/mLAlembic Pharmaceuticals LimitedNone
62332-711METHOTREXATEinjection, solution25 mg/mLAlembic Pharmaceuticals Inc.None
62332-712METHOTREXATEinjection, solution25 mg/mLAlembic Pharmaceuticals Inc.None
63323-123Methotrexateinjection, solution25 mg/mLFresenius Kabi USA, LLCNone
55150-513METHOTREXATEinjection, solution250 mg/10mLEugia US LLCNone
55150-510METHOTREXATEinjection, solution50 mg/2mLEugia US LLCNone

Showing 40 of 78 listings.

Questions

Is methotrexate a controlled substance?

No. Methotrexate is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and methotrexate is not on the DEA controlled substances list.

Is methotrexate a narcotic?

No. Methotrexate is not on the DEA controlled substances list, so the DEA does not classify it as a narcotic. Its FDA established pharmacologic class is Folate Analog Metabolic Inhibitor.

Does this page cover state schedules?

No. This page reports the federal schedule only. Some states schedule drugs on their own; check your state board of pharmacy.

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