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United States · US · US:51672-1373_4653c9f0-dc97-b1e2-e063-6294a90aaf8b

Tazarotene

Orange BookUNIISPLATC D05AX05

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

Identification

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

Packs · 2

  • ndc11
    5167213732
    1 TUBE in 1 CARTON (51672-1373-2) / 30 g in 1 TUBE
  • ndc11
    5167213733
    1 TUBE in 1 CARTON (51672-1373-3) / 60 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
81BDR9Y8PS
TAZAROTENE
RxCUI 83947
Orange Book
A208258
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": "51672-1373_4653c9f0-dc97-b1e2-e063-6294a90aaf8b",
  "productndc": "51672-1373",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "208258",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.1%",
        "product_no": "001",
        "approval_date": "Apr 3, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TAZAROTENE",
  "proprietary_name": "Tazarotene",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA208258",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tazarotene",
  "start_marketing_date": "20170403",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code D05AX05.

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