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United States · US · US:69097-686_01ca8568-cd52-42e0-87b8-2eea35a77364

TAVABOROLE

Orange BookUNIISPLATC D01AE24

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

Identification

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

Packs · 1

  • ndc11
    6909768637
    1 BOTTLE, WITH APPLICATOR in 1 CARTON (69097-686-37) / 10 mL in 1 BOTTLE, WITH APPLICATOR

Annotations

UNII (FDA Substance ID)
K124A4EUQ3
TAVABOROLE
RxCUI 1543173
Orange Book
A212224
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": "69097-686_01ca8568-cd52-42e0-87b8-2eea35a77364",
  "productndc": "69097-686",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "212224",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5%",
        "product_no": "001",
        "approval_date": "Feb 9, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TAVABOROLE",
  "proprietary_name": "TAVABOROLE",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA212224",
  "marketing_category": "ANDA",
  "nonproprietary_name": "TAVABOROLE",
  "start_marketing_date": "20210218",
  "active_numerator_strength": "43.5"
}

Related drugs

Other records sharing ATC code D01AE24.

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