Clindamycin Phosphate and Benzoyl Peroxide

Orange BookSPL

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

Identification

ManufacturerMylan Pharmaceuticals Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0378868835
1 KIT in 1 CARTON (0378-8688-35) * 5 g in 1 BOTTLE, PLASTIC * 20 g in 1 JAR

Annotations

Orange Book

A065443

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "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": "0378-8688_7ab087d0-276c-4b45-9685-9e6dc5ea1920",
  "productndc": "0378-8688",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "065443",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5%;EQ 1% BASE",
        "product_no": "001",
        "approval_date": "Aug 11, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Clindamycin Phosphate and Benzoyl Peroxide",
  "active_ingred_unit": null,
  "application_number": "ANDA065443",
  "marketing_category": "ANDA",
  "nonproprietary_name": "clindamycin phosphate and benzoyl peroxide",
  "start_marketing_date": "20140919",
  "active_numerator_strength": null
}

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