Tacrolimus

Orange BookUNIISPLATC L04AD02

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

Identification

ManufacturerAmerican Health Packaging

CountryUS (United States)

ATC codeL04AD02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6808444901
100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-449-01) / 1 CAPSULE in 1 BLISTER PACK (68084-449-11)

Annotations

UNII (FDA Substance ID)

WM0HAQ4WNM

TACROLIMUS

RxCUI 484288

Orange Book

A090509

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": {
    "0a557ca9-b1a1-cf8f-a317-e4d8d4d6e60f": {
      "match": "brand_token",
      "title": "TACROLIMUS (TACROLIMUS) CAPSULE [BIOCON PHARMA INC.]",
      "spl_version": "12",
      "published_date": "2026-05-26"
    }
  },
  "productid": "68084-449_249a483c-c5c4-11c3-e063-6394a90a0e2e",
  "productndc": "68084-449",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "090509",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 0.5MG BASE",
        "product_no": "001",
        "approval_date": "May 12, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "002",
        "approval_date": "May 12, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "003",
        "approval_date": "May 12, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TACROLIMUS",
  "proprietary_name": "Tacrolimus",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090509",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tacrolimus",
  "start_marketing_date": "20100803",
  "active_numerator_strength": ".5"
}

Related drugs

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