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United States · US · US:21922-050_854a8cf5-cfcf-4189-af34-e111363266a1

Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025%

In shortageOrange BookUNIISPLATC D10AF

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

Identification

ManufacturerEncube Ethicals, Inc.
CountryUS (United States)
ATC codeD10AF
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    2192205005
    1 TUBE in 1 CARTON (21922-050-05) / 30 g in 1 TUBE
  • ndc11
    2192205007
    1 TUBE in 1 CARTON (21922-050-07) / 60 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
EH6D7113I8
CLINDAMYCIN PHOSPHATE
RxCUI 797272
Orange Book
A216943
AB2
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Clindamycin Phosphate; Benzoyl Peroxide Gel
Raw payload (JSON)
{
  "unii": {
    "unii": "EH6D7113I8",
    "rxcui": "797272",
    "inchikey": "UFUVLHLTWXBHGZ-MGZQPHGTSA-N",
    "display_name": "CLINDAMYCIN PHOSPHATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "27747e01-85eb-44de-a4a6-711a7799218a": {
      "match": "brand_token",
      "title": "CLINDAMYCIN PHOSPHATE SOLUTION [BRYANT RANCH PREPACK]",
      "spl_version": "111",
      "published_date": "2026-06-01"
    }
  },
  "productid": "21922-050_854a8cf5-cfcf-4189-af34-e111363266a1",
  "productndc": "21922-050",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "216943",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "1.2%;0.025%",
        "product_no": "001",
        "approval_date": "Sep 1, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLINDAMYCIN PHOSPHATE; TRETINOIN",
  "shortage_reason": "Clindamycin Phosphate; Benzoyl Peroxide Gel",
  "shortage_status": "current",
  "proprietary_name": "Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025%",
  "active_ingred_unit": "mg/g; mg/g",
  "application_number": "ANDA216943",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025%",
  "start_marketing_date": "20230904",
  "active_numerator_strength": "10; .25"
}

Related drugs

Other records sharing ATC code D10AF.

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