Azathioprine

Orange BookUNIISPLATC L04AX01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerZydus Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeL04AX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6838212001
100 TABLET in 1 BOTTLE (68382-120-01)
ndc11
6838212005
500 TABLET in 1 BOTTLE (68382-120-05)

Annotations

UNII (FDA Substance ID)

MRK240IY2L

AZATHIOPRINE

RxCUI 1256

Orange Book

A077621

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": "68382-120_64e1751f-fdf5-45e7-ac57-6499c0b5aa91",
  "productndc": "68382-120",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "077621",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Mar 15, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Sep 5, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "75MG",
        "product_no": "003",
        "approval_date": "Sep 5, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "004",
        "approval_date": "Sep 5, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AZATHIOPRINE",
  "proprietary_name": "Azathioprine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077621",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Azathioprine",
  "start_marketing_date": "20171202",
  "active_numerator_strength": "100"
}

Related drugs

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