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United States · US · US:82804-032_20d1c12a-bf4b-4467-93a0-ee8b892abea9

Tacrolimus

Orange BookUNIISPLATC L04AD02

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeL04AD02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    8280403230
    30 CAPSULE in 1 BOTTLE (82804-032-30)
  • ndc11
    8280403260
    60 CAPSULE in 1 BOTTLE (82804-032-60)
  • ndc11
    8280403290
    90 CAPSULE in 1 BOTTLE (82804-032-90)

Annotations

UNII (FDA Substance ID)
WM0HAQ4WNM
TACROLIMUS
RxCUI 484288
Orange Book
A065461
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": "82804-032_20d1c12a-bf4b-4467-93a0-ee8b892abea9",
  "productndc": "82804-032",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "065461",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 0.5MG BASE",
        "product_no": "001",
        "approval_date": "Aug 10, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "002",
        "approval_date": "Aug 10, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "003",
        "approval_date": "Aug 10, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TACROLIMUS",
  "proprietary_name": "Tacrolimus",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA065461",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tacrolimus",
  "start_marketing_date": "20090810",
  "active_numerator_strength": "1"
}

Related drugs

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