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United States · US · US:45802-510_84f65326-838e-412d-a5b4-44a28cea1415

clindamycin and benzoyl peroxide

Orange BookSPL

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

Identification

ManufacturerPadagis Israel Pharmaceuticals Ltd
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4580251003
    1 KIT in 1 CARTON (45802-510-03) * .4 g in 1 VIAL (45802-738-03) * 27.6 g in 1 BOTTLE, PUMP (45802-998-03)

Annotations

Orange Book
A202440
AB
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": "45802-510_84f65326-838e-412d-a5b4-44a28cea1415",
  "productndc": "45802-510",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "202440",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5%;EQ 1% BASE",
        "product_no": "001",
        "approval_date": "Sep 21, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "clindamycin and benzoyl peroxide",
  "active_ingred_unit": null,
  "application_number": "ANDA202440",
  "marketing_category": "ANDA",
  "nonproprietary_name": "clindamycin and benzoyl peroxide",
  "start_marketing_date": "20210308",
  "active_numerator_strength": null
}

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