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United States · US · US:43538-172_24aae3bd-54de-429d-9587-c156b5949f40

Clindacin ETZ

In shortageOrange BookUNIISPLATC G01AA10

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

Identification

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

Packs · 2

  • ndc11
    4353817260
    60 PACKET in 1 CARTON (43538-172-60) / 1 SWAB in 1 PACKET
  • ndc11
    4353817299
    12 PACKET in 1 CARTON (43538-172-99) / 1 SWAB in 1 PACKET

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 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": {
    "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": "43538-172_24aae3bd-54de-429d-9587-c156b5949f40",
  "productndc": "43538-172",
  "dosage_form": "SWAB",
  "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 Palmitate Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "Clindacin ETZ",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA065049",
  "marketing_category": "ANDA",
  "nonproprietary_name": "clindamycin phosphate",
  "start_marketing_date": "20130615",
  "active_numerator_strength": "10"
}

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