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United States · US · US:0009-3448_08bcc2dc-71ea-4664-89e8-73d6a3a01322

Cleocin

In shortageOrange BookUNIISPLATC G01AA10

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

Identification

ManufacturerPharmacia & Upjohn Company LLC
CountryUS (United States)
ATC codeG01AA10
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0009344801
    1 TUBE, WITH APPLICATOR in 1 CARTON (0009-3448-01) / 40 g in 1 TUBE, WITH APPLICATOR

Annotations

UNII (FDA Substance ID)
EH6D7113I8
CLINDAMYCIN PHOSPHATE
RxCUI 797272
Orange Book
N050680
AB
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": {
    "a0a2eff7-b7de-42fe-8e5a-0cfbed38bb4b": {
      "match": "brand_token",
      "title": "CLEOCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE) INJECTION, SOLUTION [PHARMACIA & UPJOHN COMPANY LLC]",
      "spl_version": "15",
      "published_date": "2026-05-21"
    }
  },
  "productid": "0009-3448_08bcc2dc-71ea-4664-89e8-73d6a3a01322",
  "productndc": "0009-3448",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "050680",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 2% BASE",
        "product_no": "001",
        "approval_date": "Aug 11, 1992"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 2% BASE",
        "product_no": "002",
        "approval_date": "Mar 2, 1998"
      }
    ],
    "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": "Cleocin",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA050680",
  "marketing_category": "NDA",
  "nonproprietary_name": "clindamycin phosphate",
  "start_marketing_date": "19920811",
  "active_numerator_strength": "20"
}

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