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United States · US · US:71335-1118_5f07ff4f-6a15-4a3e-a478-e6892306fd24

Methotrexate

In shortageOrange BookUNIISPLATC L04AX03

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeL04AX03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 8

  • ndc11
    7133511181
    30 TABLET in 1 BOTTLE (71335-1118-1)
  • ndc11
    7133511182
    12 TABLET in 1 BOTTLE (71335-1118-2)
  • ndc11
    7133511183
    20 TABLET in 1 BOTTLE (71335-1118-3)
  • ndc11
    7133511184
    100 TABLET in 1 BOTTLE (71335-1118-4)
  • ndc11
    7133511185
    36 TABLET in 1 BOTTLE (71335-1118-5)
  • ndc11
    7133511186
    24 TABLET in 1 BOTTLE (71335-1118-6)
  • ndc11
    7133511187
    90 TABLET in 1 BOTTLE (71335-1118-7)
  • ndc11
    7133511188
    4 TABLET in 1 BOTTLE (71335-1118-8)

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 Sodium 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": "71335-1118_5f07ff4f-6a15-4a3e-a478-e6892306fd24",
  "productndc": "71335-1118",
  "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 Sodium Injection",
  "shortage_status": "current",
  "proprietary_name": "Methotrexate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA081235",
  "marketing_category": "ANDA",
  "nonproprietary_name": "methotrexate",
  "start_marketing_date": "19920518",
  "active_numerator_strength": "2.5"
}

Related drugs

Other records sharing ATC code L04AX03.

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