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United States · US · US:71335-2189_bcd0e46a-cabb-4a0d-81c8-f41368a3bd74

Tacrolimus

Orange BookUNIISPLATC L04AD02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeL04AD02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7133521891
    60 CAPSULE in 1 BOTTLE (71335-2189-1)

Annotations

UNII (FDA Substance ID)
WM0HAQ4WNM
TACROLIMUS
RxCUI 484288
Orange Book
A091195
BXBXBX
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": "71335-2189_bcd0e46a-cabb-4a0d-81c8-f41368a3bd74",
  "productndc": "71335-2189",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "091195",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "BX",
        "strength": "EQ 0.5MG BASE",
        "product_no": "001",
        "approval_date": "Aug 31, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "BX",
        "strength": "EQ 1MG BASE",
        "product_no": "002",
        "approval_date": "Aug 31, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "BX",
        "strength": "EQ 5MG BASE",
        "product_no": "003",
        "approval_date": "Aug 31, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TACROLIMUS",
  "proprietary_name": "Tacrolimus",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA091195",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tacrolimus",
  "start_marketing_date": "20110930",
  "active_numerator_strength": ".5"
}

Related drugs

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