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United States · US · US:62332-467_d35e58d2-869d-40bf-a00e-296a9d3bb659

Tavaborole

Orange BookUNIISPLATC D01AE24

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

Identification

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

Packs · 2

  • ndc11
    6233246704
    1 BOTTLE, DROPPER in 1 CARTON (62332-467-04) / 4 mL in 1 BOTTLE, DROPPER
  • ndc11
    6233246710
    1 BOTTLE, DROPPER in 1 CARTON (62332-467-10) / 10 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
K124A4EUQ3
TAVABOROLE
RxCUI 1543173
Orange Book
A212188
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": "62332-467_d35e58d2-869d-40bf-a00e-296a9d3bb659",
  "productndc": "62332-467",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "212188",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5%",
        "product_no": "001",
        "approval_date": "Oct 21, 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": "ANDA212188",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tavaborole",
  "start_marketing_date": "20201023",
  "active_numerator_strength": "43.5"
}

Related drugs

Other records sharing ATC code D01AE24.

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