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United States · US · US:68308-685_6096a6e0-932a-4eb2-a15a-4fb7b2cd8f67

tazarotene

Orange BookUNIISPLATC D05AX05

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

Identification

ManufacturerMayne Pharma Inc.
CountryUS (United States)
ATC codeD05AX05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6830868550
    1 CAN in 1 CARTON (68308-685-50) / 50 g in 1 CAN

Annotations

UNII (FDA Substance ID)
81BDR9Y8PS
TAZAROTENE
RxCUI 83947
Orange Book
N202428
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": "68308-685_6096a6e0-932a-4eb2-a15a-4fb7b2cd8f67",
  "productndc": "68308-685",
  "dosage_form": "AEROSOL, FOAM",
  "orange_book": {
    "appl_no": "202428",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.1%",
        "product_no": "001",
        "approval_date": "May 11, 2012"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TAZAROTENE",
  "proprietary_name": "tazarotene",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA202428",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "tazarotene",
  "start_marketing_date": "20210423",
  "active_numerator_strength": "1"
}

Related drugs

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