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United States · US · US:70771-1058_ae399908-cfb6-44dc-83da-8981f5dabbb8

Methotrexate

In shortageOrange BookUNIISPLATC L04AX03

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

Identification

ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeL04AX03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    7077110580
    1000 TABLET in 1 BOTTLE (70771-1058-0)
  • ndc11
    7077110581
    100 TABLET in 1 BOTTLE (70771-1058-1)
  • ndc11
    7077110583
    36 TABLET in 1 BOTTLE (70771-1058-3)
  • ndc11
    7077110585
    500 TABLET in 1 BOTTLE (70771-1058-5)
  • ndc11
    7077110587
    100 BLISTER PACK in 1 CARTON (70771-1058-7) / 1 TABLET in 1 BLISTER PACK (70771-1058-2)
  • ndc11
    7077110589
    90 TABLET in 1 BOTTLE (70771-1058-9)

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": "70771-1058_ae399908-cfb6-44dc-83da-8981f5dabbb8",
  "productndc": "70771-1058",
  "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.

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