ASTAGRAF XL

Orange BookUNIISPLATC L04AD02

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

Identification

ManufacturerAstellas Pharma US, Inc.

CountryUS (United States)

ATC codeL04AD02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0469068773
1 BOTTLE in 1 CARTON (0469-0687-73) / 30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

WM0HAQ4WNM

TACROLIMUS

RxCUI 484288

Orange Book

N204096

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "WM0HAQ4WNM",
    "rxcui": "484288",
    "inchikey": "NWJQLQGQZSIBAF-MLAUYUEBSA-N",
    "display_name": "TACROLIMUS",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e": {
      "match": "brand_token",
      "title": "ASTAGRAF XL (TACROLIMUS EXTENDED-RELEASE CAPSULES) CAPSULE, COATED, EXTENDED RELEASE [ASTELLAS PHARMA US, INC.]",
      "spl_version": "12",
      "published_date": "2026-02-06"
    }
  },
  "productid": "0469-0687_4ecfe626-bf9c-4889-a1d4-64b03d60eaf8",
  "productndc": "0469-0687",
  "dosage_form": "CAPSULE, COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "204096",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 0.5MG BASE",
        "product_no": "001",
        "approval_date": "Jul 19, 2013"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "002",
        "approval_date": "Jul 19, 2013"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "003",
        "approval_date": "Jul 19, 2013"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TACROLIMUS",
  "proprietary_name": "ASTAGRAF XL",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA204096",
  "marketing_category": "NDA",
  "nonproprietary_name": "tacrolimus extended-release capsules",
  "start_marketing_date": "20130719",
  "active_numerator_strength": "5"
}

Related drugs

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