Tacrolimus

Orange BookUNIISPLATC L04AD02

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

Identification

ManufacturerHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd

CountryUS (United States)

ATC codeL04AD02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6589700091
1 BAG in 1 CARTON (65897-0009-1) / 10 BLISTER PACK in 1 BAG / 10 CAPSULE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

Y5L2157C4J

TACROLIMUS ANHYDROUS

RxCUI 235991

Orange Book

A210929

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "Y5L2157C4J",
    "rxcui": "235991",
    "inchikey": "QJJXYPPXXYFBGM-LFZNUXCKSA-N",
    "display_name": "TACROLIMUS ANHYDROUS",
    "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": "65897-0009_39a2918e-2da4-a843-e063-6294a90a9fec",
  "productndc": "65897-0009",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "210929",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 0.5MG BASE",
        "product_no": "001",
        "approval_date": "Apr 17, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 1MG BASE",
        "product_no": "002",
        "approval_date": "Apr 17, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 5MG BASE",
        "product_no": "003",
        "approval_date": "Apr 17, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TACROLIMUS ANHYDROUS",
  "proprietary_name": "Tacrolimus",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210929",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tacrolimus",
  "start_marketing_date": "20250711",
  "active_numerator_strength": ".5"
}

Related drugs

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