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United States · US · US:16729-421_23a804e6-2854-6b9b-e063-6394a90af669

Tacrolimus

Orange BookUNIISPLATC L04AD02

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

Identification

ManufacturerAccord Healthcare Inc.
CountryUS (United States)
ATC codeL04AD02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    1672942101
    1 TUBE in 1 CARTON (16729-421-01) / 100 g in 1 TUBE
  • ndc11
    1672942110
    1 TUBE in 1 CARTON (16729-421-10) / 30 g in 1 TUBE
  • ndc11
    1672942112
    1 TUBE in 1 CARTON (16729-421-12) / 60 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
WM0HAQ4WNM
TACROLIMUS
RxCUI 484288
Orange Book
A211688
ABAB
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": "TOPICAL",
  "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": "16729-421_23a804e6-2854-6b9b-e063-6394a90af669",
  "productndc": "16729-421",
  "dosage_form": "OINTMENT",
  "orange_book": {
    "appl_no": "211688",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.03%",
        "product_no": "001",
        "approval_date": "Jan 31, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.1%",
        "product_no": "002",
        "approval_date": "Jan 31, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TACROLIMUS",
  "proprietary_name": "Tacrolimus",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA211688",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tacrolimus",
  "start_marketing_date": "20190531",
  "active_numerator_strength": ".3"
}

Related drugs

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