Clindamycin Phosphate

In shortageOrange BookUNIISPLATC G01AA10

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC

CountryUS (United States)

ATC codeG01AA10

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0168027740
40 g in 1 TUBE, WITH APPLICATOR (0168-0277-40)

Annotations

UNII (FDA Substance ID)

EH6D7113I8

CLINDAMYCIN PHOSPHATE

RxCUI 797272

Orange Book

A065139

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": "VAGINAL",
  "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": "0168-0277_6831719c-6e74-41d9-ab44-225fa088e3a6",
  "productndc": "0168-0277",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "065139",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2% BASE",
        "product_no": "001",
        "approval_date": "Dec 27, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLINDAMYCIN PHOSPHATE",
  "shortage_reason": "Clindamycin Phosphate; Benzoyl Peroxide Gel",
  "shortage_status": "current",
  "proprietary_name": "Clindamycin Phosphate",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA065139",
  "marketing_category": "ANDA",
  "nonproprietary_name": "clindamycin phosphate",
  "start_marketing_date": "20041227",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code G01AA10.

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