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United States · US · US:71335-0782_c5595381-c3bc-43a4-9c65-0b68b454a891

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
    7133507821
    30 TABLET in 1 BOTTLE (71335-0782-1)
  • ndc11
    7133507822
    12 TABLET in 1 BOTTLE (71335-0782-2)
  • ndc11
    7133507823
    20 TABLET in 1 BOTTLE (71335-0782-3)
  • ndc11
    7133507824
    100 TABLET in 1 BOTTLE (71335-0782-4)
  • ndc11
    7133507825
    36 TABLET in 1 BOTTLE (71335-0782-5)
  • ndc11
    7133507826
    24 TABLET in 1 BOTTLE (71335-0782-6)
  • ndc11
    7133507827
    90 TABLET in 1 BOTTLE (71335-0782-7)
  • ndc11
    7133507828
    4 TABLET in 1 BOTTLE (71335-0782-8)

Annotations

UNII (FDA Substance ID)
3IG1E710ZN
METHOTREXATE SODIUM
RxCUI 287734
Orange Book
A081099
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": "71335-0782_c5595381-c3bc-43a4-9c65-0b68b454a891",
  "productndc": "71335-0782",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "081099",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE",
        "product_no": "001",
        "approval_date": "Oct 15, 1990"
      }
    ],
    "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": "ANDA081099",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Methotrexate",
  "start_marketing_date": "19901101",
  "active_numerator_strength": "2.5"
}

Related drugs

Other records sharing ATC code L04AX03.

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