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United States · US · US:21922-020_10a126f9-ec1b-44d2-8611-3d6660a53ae8

Tavaborole

Orange BookUNIISPLATC D01AE24

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

Identification

ManufacturerEncube Ethicals, Inc.
CountryUS (United States)
ATC codeD01AE24
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2192202012
    1 BOTTLE, WITH APPLICATOR in 1 CARTON (21922-020-12) / 10 mL in 1 BOTTLE, WITH APPLICATOR

Annotations

UNII (FDA Substance ID)
K124A4EUQ3
TAVABOROLE
RxCUI 1543173
Orange Book
A211297
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "K124A4EUQ3",
    "rxcui": "1543173",
    "inchikey": "LFQDNHWZDQTITF-UHFFFAOYSA-N",
    "display_name": "TAVABOROLE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "37004451-0345-4e00-96be-f05db600fb9f": {
      "match": "brand_token",
      "title": "TAVABOROLE SOLUTION [CIPLA USA INC.]",
      "spl_version": "3",
      "published_date": "2025-12-22"
    }
  },
  "productid": "21922-020_10a126f9-ec1b-44d2-8611-3d6660a53ae8",
  "productndc": "21922-020",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "211297",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "5%",
        "product_no": "001",
        "approval_date": "Oct 13, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TAVABOROLE",
  "proprietary_name": "Tavaborole",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA211297",
  "marketing_category": "ANDA",
  "nonproprietary_name": "TAVABOROLE topical solution, 5%",
  "start_marketing_date": "20201019",
  "active_numerator_strength": "43.5"
}

Related drugs

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