clindamycin hydrochloride

In shortageOrange BookUNIISPLATC G01AA10

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAmneal Pharmaceuticals NY LLC

CountryUS (United States)

ATC codeG01AA10

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6923821213
3 BLISTER PACK in 1 CARTON (69238-2121-3) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (69238-2121-4)

Annotations

UNII (FDA Substance ID)

T20OQ1YN1W

CLINDAMYCIN HYDROCHLORIDE

RxCUI 81982

Orange Book

A065194

ABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Clindamycin Palmitate Hydrochloride Injection

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": "69238-2121_f118e287-5acc-4a8b-bcf0-01436de5bdf9",
  "productndc": "69238-2121",
  "dosage_form": "CAPSULE, GELATIN COATED",
  "orange_book": {
    "appl_no": "065194",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 150MG BASE",
        "product_no": "001",
        "approval_date": "Mar 22, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 300MG BASE",
        "product_no": "002",
        "approval_date": "Mar 22, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLINDAMYCIN HYDROCHLORIDE",
  "shortage_reason": "Clindamycin Palmitate Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "clindamycin hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA065194",
  "marketing_category": "ANDA",
  "nonproprietary_name": "clindamycin hydrochloride",
  "start_marketing_date": "20220425",
  "active_numerator_strength": "300"
}

Related drugs

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