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United States · US · US:45802-706_27ddf7ba-f3a2-43ff-83a5-e7c95b355028

TAZAROTENE

Orange BookUNIISPLATC D05AX05

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

Identification

ManufacturerPadagis Israel Pharmaceuticals Ltd
CountryUS (United States)
ATC codeD05AX05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4580270694
    1 TUBE in 1 CARTON (45802-706-94) / 30 g in 1 TUBE
  • ndc11
    4580270696
    1 TUBE in 1 CARTON (45802-706-96) / 60 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
81BDR9Y8PS
TAZAROTENE
RxCUI 83947
Orange Book
A217075
AB
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": "TOPICAL",
  "spl_meta": {
    "478ff059-9d7b-438e-a64e-c853dfac2872": {
      "match": "brand_token",
      "title": "TAZAROTENE CREAM [SUN PHARMACEUTICAL INDUSTRIES, INC.]",
      "spl_version": "6",
      "published_date": "2025-12-22"
    }
  },
  "productid": "45802-706_27ddf7ba-f3a2-43ff-83a5-e7c95b355028",
  "productndc": "45802-706",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "217075",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.05%",
        "product_no": "001",
        "approval_date": "Jul 15, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TAZAROTENE",
  "proprietary_name": "TAZAROTENE",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA217075",
  "marketing_category": "ANDA",
  "nonproprietary_name": "tazarotene",
  "start_marketing_date": "20240909",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code D05AX05.

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