tacrolimus

Orange BookUNIISPLATC L04AD02

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

Identification

ManufacturerChengdu Suncadia Medicine Co., Ltd.

CountryUS (United States)

ATC codeL04AD02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7143220011
1 BAG in 1 CARTON (71432-2001-1) / 5 BLISTER PACK in 1 BAG / 10 CAPSULE, COATED, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

WM0HAQ4WNM

TACROLIMUS

RxCUI 484288

Orange Book

A215012

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": "71432-2001_102bdf7c-9d79-0124-e063-6394a90aced9",
  "productndc": "71432-2001",
  "dosage_form": "CAPSULE, COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "215012",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 0.5MG BASE",
        "product_no": "001",
        "approval_date": "Jan 25, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "002",
        "approval_date": "Jan 25, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "003",
        "approval_date": "Jan 25, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TACROLIMUS",
  "proprietary_name": "tacrolimus",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA215012",
  "marketing_category": "ANDA",
  "nonproprietary_name": "tacrolimus extended-release capsules",
  "start_marketing_date": "20240125",
  "active_numerator_strength": ".5"
}

Related drugs

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