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United States · US · US:70518-3544_4f58b212-db57-4132-e063-6394a90a1cdf

Azathioprine

Orange BookUNIISPLATC L04AX01

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

Identification

ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeL04AX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7051835440
    100 POUCH in 1 BOX (70518-3544-0) / 1 TABLET in 1 POUCH (70518-3544-1)

Annotations

UNII (FDA Substance ID)
MRK240IY2L
AZATHIOPRINE
RxCUI 1256
Orange Book
A208687
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "MRK240IY2L",
    "rxcui": "1256",
    "inchikey": "LMEKQMALGUDUQG-UHFFFAOYSA-N",
    "display_name": "AZATHIOPRINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "5116b22b-1460-5535-e063-6394a90acbe5": {
      "match": "brand_token",
      "title": "AZATHIOPRINE TABLET [NUCARE PHARMACEUTICALS,INC.]",
      "spl_version": "1",
      "published_date": "2026-05-07"
    }
  },
  "productid": "70518-3544_4f58b212-db57-4132-e063-6394a90a1cdf",
  "productndc": "70518-3544",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "208687",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Mar 27, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Mar 27, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "75MG",
        "product_no": "003",
        "approval_date": "Mar 27, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "004",
        "approval_date": "Mar 27, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AZATHIOPRINE",
  "proprietary_name": "Azathioprine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208687",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Azathioprine",
  "start_marketing_date": "20220930",
  "active_numerator_strength": "50"
}

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