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United States · US · US:43538-170_46465f9a-1b07-4044-9598-55a211b95297

Clindacin P

In shortageOrange BookUNIISPLATC G01AA10

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

Identification

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

Packs · 1

  • ndc11
    4353817069
    69 APPLICATOR in 1 JAR (43538-170-69) / 1 mL in 1 APPLICATOR

Annotations

UNII (FDA Substance ID)
EH6D7113I8
CLINDAMYCIN PHOSPHATE
RxCUI 797272
Orange Book
A065049
AT
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Clindamycin Hydrochloride Capsule
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": {
    "89fed26e-1cad-4c0b-8695-d6f3562ba8d5": {
      "match": "brand_token",
      "title": "CLINDACIN ETZ (CLINDAMYCIN PHOSPHATE) SWAB [EUROFARMA, INC.]",
      "spl_version": "7",
      "published_date": "2026-04-13"
    }
  },
  "productid": "43538-170_46465f9a-1b07-4044-9598-55a211b95297",
  "productndc": "43538-170",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "065049",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AT",
        "strength": "EQ 1% BASE",
        "product_no": "001",
        "approval_date": "May 25, 2000"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLINDAMYCIN PHOSPHATE",
  "shortage_reason": "Clindamycin Hydrochloride Capsule",
  "shortage_status": "current",
  "proprietary_name": "Clindacin P",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA065049",
  "marketing_category": "ANDA",
  "nonproprietary_name": "clindamycin phosphate",
  "start_marketing_date": "20110220",
  "active_numerator_strength": "10"
}

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