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United States · US · US:0904-7194_3d17632f-136b-4ad5-b440-5e7f9989a51f

Clindamycin Hydrochloride

In shortageOrange BookUNIISPLATC G01AA10

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

Identification

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

Packs · 1

  • ndc11
    0904719461
    100 BLISTER PACK in 1 CARTON (0904-7194-61) / 1 CAPSULE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
T20OQ1YN1W
CLINDAMYCIN HYDROCHLORIDE
RxCUI 81982
Orange Book
A065442
ABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Clindamycin Phosphate; Benzoyl Peroxide Gel
Raw payload (JSON)
{
  "unii": {
    "unii": "T20OQ1YN1W",
    "rxcui": "81982",
    "inchikey": "AUODDLQVRAJAJM-XJQDNNTCSA-N",
    "display_name": "CLINDAMYCIN HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "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": "0904-7194_3d17632f-136b-4ad5-b440-5e7f9989a51f",
  "productndc": "0904-7194",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "065442",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 150MG BASE",
        "product_no": "001",
        "approval_date": "Aug 26, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 300MG BASE",
        "product_no": "002",
        "approval_date": "Aug 26, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLINDAMYCIN HYDROCHLORIDE",
  "shortage_reason": "Clindamycin Phosphate; Benzoyl Peroxide Gel",
  "shortage_status": "current",
  "proprietary_name": "Clindamycin Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA065442",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clindamycin Hydrochloride",
  "start_marketing_date": "20090826",
  "active_numerator_strength": "300"
}

Related drugs

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