Clindamycin Palmitate Hydrochloride

In shortageOrange BookUNIISPLATC G01AA10

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

Identification

ManufacturerAmneal Pharmaceuticals LLC

CountryUS (United States)

ATC codeG01AA10

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6516246819
1 BOTTLE in 1 CARTON (65162-468-19) / 100 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

VN9A8JM7M7

CLINDAMYCIN PALMITATE HYDROCHLORIDE

RxCUI 91075

Orange Book

A203513

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Clindamycin Palmitate Hydrochloride Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "VN9A8JM7M7",
    "rxcui": "91075",
    "inchikey": "GTNDZRUWKHDICY-DJHAJVGHSA-N",
    "display_name": "CLINDAMYCIN PALMITATE 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": "65162-468_4480ac35-28fd-48fc-b0eb-52349d30ad8e",
  "productndc": "65162-468",
  "dosage_form": "POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "203513",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 75MG BASE/5ML",
        "product_no": "001",
        "approval_date": "Mar 13, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLINDAMYCIN PALMITATE HYDROCHLORIDE",
  "shortage_reason": "Clindamycin Palmitate Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "Clindamycin Palmitate Hydrochloride",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA203513",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clindamycin Palmitate Hydrochloride",
  "start_marketing_date": "20130902",
  "active_numerator_strength": "75"
}

Related drugs

Other records sharing ATC code G01AA10.

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