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United States · US · US:71335-1772_17125571-6b01-40cb-ab78-7b9f4f8cc16c

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
    7133517721
    30 TABLET in 1 BOTTLE (71335-1772-1)
  • ndc11
    7133517722
    12 TABLET in 1 BOTTLE (71335-1772-2)
  • ndc11
    7133517723
    20 TABLET in 1 BOTTLE (71335-1772-3)
  • ndc11
    7133517724
    100 TABLET in 1 BOTTLE (71335-1772-4)
  • ndc11
    7133517725
    36 TABLET in 1 BOTTLE (71335-1772-5)
  • ndc11
    7133517726
    24 TABLET in 1 BOTTLE (71335-1772-6)
  • ndc11
    7133517727
    90 TABLET in 1 BOTTLE (71335-1772-7)
  • ndc11
    7133517728
    4 TABLET in 1 BOTTLE (71335-1772-8)

Annotations

UNII (FDA Substance ID)
3IG1E710ZN
METHOTREXATE SODIUM
RxCUI 287734
Orange Book
A213343
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": "71335-1772_17125571-6b01-40cb-ab78-7b9f4f8cc16c",
  "productndc": "71335-1772",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "213343",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE",
        "product_no": "001",
        "approval_date": "Jan 24, 2020"
      }
    ],
    "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": "ANDA213343",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Methotrexate",
  "start_marketing_date": "20200824",
  "active_numerator_strength": "2.5"
}

Related drugs

Other records sharing ATC code L04AX03.

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