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United States · US · US:80005-131_afc7cc5c-76c8-4807-82c2-765f51bdacd3

Clindamycin Phosphate

In shortageOrange BookUNIISPLATC G01AA10

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

Identification

ManufacturerCarnegie Pharmaceuticals, LLC
CountryUS (United States)
ATC codeG01AA10
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    8000513109
    60 APPLICATOR in 1 JAR (80005-131-09) / 1 mL in 1 APPLICATOR
  • ndc11
    8000513138
    69 APPLICATOR in 1 JAR (80005-131-38) / 1 mL in 1 APPLICATOR

Annotations

UNII (FDA Substance ID)
EH6D7113I8
CLINDAMYCIN PHOSPHATE
RxCUI 797272
Orange Book
A219612
AT
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Clindamycin Palmitate Hydrochloride Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "EH6D7113I8",
    "rxcui": "797272",
    "inchikey": "UFUVLHLTWXBHGZ-MGZQPHGTSA-N",
    "display_name": "CLINDAMYCIN PHOSPHATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "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": "80005-131_afc7cc5c-76c8-4807-82c2-765f51bdacd3",
  "productndc": "80005-131",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "219612",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "EQ 1% BASE",
        "product_no": "001",
        "approval_date": "Jun 13, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLINDAMYCIN PHOSPHATE",
  "shortage_reason": "Clindamycin Palmitate Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "Clindamycin Phosphate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA219612",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clindamycin Phosphate Topical",
  "start_marketing_date": "20250616",
  "active_numerator_strength": "10"
}

Related drugs

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