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United States · US · US:0713-0765_3001f737-a4db-b824-e063-6294a90a784e

Tazarotene

Orange BookUNIISPLATC D05AX05

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

Identification

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

Packs · 2

  • ndc11
    0713076531
    1 TUBE in 1 CARTON (0713-0765-31) / 30 g in 1 TUBE
  • ndc11
    0713076560
    1 TUBE in 1 CARTON (0713-0765-60) / 60 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
81BDR9Y8PS
TAZAROTENE
RxCUI 83947
Orange Book
A208662
ABAB
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": "0713-0765_3001f737-a4db-b824-e063-6294a90a784e",
  "productndc": "0713-0765",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "208662",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.1%",
        "product_no": "001",
        "approval_date": "Dec 22, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.05%",
        "product_no": "002",
        "approval_date": "Mar 10, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TAZAROTENE",
  "proprietary_name": "Tazarotene",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA208662",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tazarotene",
  "start_marketing_date": "20250310",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code D05AX05.

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