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United States · US · US:16110-916_ee97b76e-eb11-4165-ae85-1277eba9ff35

TAZORAC

Orange BookUNIISPLATC D05AX05

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

Identification

ManufacturerAlmirall, LLC
CountryUS (United States)
ATC codeD05AX05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    1611091630
    1 TUBE in 1 CARTON (16110-916-30) / 30 g in 1 TUBE
  • ndc11
    1611091660
    1 TUBE in 1 CARTON (16110-916-60) / 60 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
81BDR9Y8PS
TAZAROTENE
RxCUI 83947
Orange Book
N021184
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "81BDR9Y8PS",
    "rxcui": "83947",
    "inchikey": "OGQICQVSFDPSEI-UHFFFAOYSA-N",
    "display_name": "TAZAROTENE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "CUTANEOUS",
  "spl_meta": {
    "4e4e4b81-420e-4492-8a74-80b692a80057": {
      "match": "brand_token",
      "title": "TAZORAC (TAZAROTENE) GEL [ALMIRALL, LLC]",
      "spl_version": "4",
      "published_date": "2025-11-18"
    }
  },
  "productid": "16110-916_ee97b76e-eb11-4165-ae85-1277eba9ff35",
  "productndc": "16110-916",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "021184",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.05%",
        "product_no": "001",
        "approval_date": "Sep 29, 2000"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.1%",
        "product_no": "002",
        "approval_date": "Sep 29, 2000"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.1%",
        "product_no": "003",
        "approval_date": "Sep 30, 2002"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TAZAROTENE",
  "proprietary_name": "TAZORAC",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA021184",
  "marketing_category": "NDA",
  "nonproprietary_name": "tazarotene",
  "start_marketing_date": "20200203",
  "active_numerator_strength": ".1"
}

Related drugs

Other records sharing ATC code D05AX05.

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