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United States · US · US:45802-042_ab0a6fe2-5ee0-408c-9e1d-30ce29344d16

Clindesse

In shortageOrange BookUNIISPLATC G01AA10

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

Identification

ManufacturerPadagis Israel Pharmaceuticals Ltd
CountryUS (United States)
ATC codeG01AA10
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4580204201
    1 APPLICATOR in 1 CARTON (45802-042-01) / 5 g in 1 APPLICATOR
  • ndc11
    4580204202
    1 APPLICATOR in 1 CARTON (45802-042-02) / 5 g in 1 APPLICATOR

Annotations

UNII (FDA Substance ID)
EH6D7113I8
CLINDAMYCIN PHOSPHATE
RxCUI 797272
Orange Book
N050793
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": {
    "fe8bb204-f173-44fe-803b-b08f2ec5aa31": {
      "match": "brand_token",
      "title": "CLINDESSE (CLINDAMYCIN PHOSPHATE) CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]",
      "spl_version": "12",
      "published_date": "2026-01-08"
    }
  },
  "productid": "45802-042_ab0a6fe2-5ee0-408c-9e1d-30ce29344d16",
  "productndc": "45802-042",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "050793",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 2% BASE",
        "product_no": "001",
        "approval_date": "Nov 30, 2004"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLINDAMYCIN PHOSPHATE",
  "shortage_reason": "Clindamycin Phosphate; Benzoyl Peroxide Gel",
  "shortage_status": "current",
  "proprietary_name": "Clindesse",
  "active_ingred_unit": "mg/5g",
  "application_number": "NDA050793",
  "marketing_category": "NDA",
  "nonproprietary_name": "clindamycin phosphate",
  "start_marketing_date": "20150703",
  "active_numerator_strength": "100"
}

Related drugs

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