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United States · US · US:0781-3288_b553b8ab-ef4d-40ae-a5fb-a6242f2ad30a

Clindamycin in 5 Percent Dextrose

In shortageOrange BookUNIISPLATC G01AA10

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

Identification

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

Packs · 1

  • ndc11
    0781328809
    24 BAG in 1 CARTON (0781-3288-09) / 50 mL in 1 BAG (0781-3288-91)

Annotations

UNII (FDA Substance ID)
3U02EL437C
CLINDAMYCIN
RxCUI 2582
Orange Book
A201692
APAPAP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Clindamycin Phosphate Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "3U02EL437C",
    "rxcui": "2582",
    "inchikey": "KDLRVYVGXIQJDK-AWPVFWJPSA-N",
    "display_name": "CLINDAMYCIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "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": "0781-3288_b553b8ab-ef4d-40ae-a5fb-a6242f2ad30a",
  "productndc": "0781-3288",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "201692",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 6MG BASE/ML",
        "product_no": "001",
        "approval_date": "May 31, 2012"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 12MG BASE/ML",
        "product_no": "002",
        "approval_date": "May 31, 2012"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 18MG BASE/ML",
        "product_no": "003",
        "approval_date": "May 31, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLINDAMYCIN",
  "shortage_reason": "Clindamycin Phosphate Injection",
  "shortage_status": "current",
  "proprietary_name": "Clindamycin in 5 Percent Dextrose",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA201692",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clindamycin in 5 Percent Dextrose",
  "start_marketing_date": "20130207",
  "active_numerator_strength": "6"
}

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