Clindamycin in 5 Percent Dextrose

In shortageOrange BookUNIISPLATC G01AA10

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

Identification

ManufacturerSandoz Inc

CountryUS (United States)

ATC codeG01AA10

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0781329009
24 BAG in 1 CARTON (0781-3290-09) / 50 mL in 1 BAG (0781-3290-91)

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; Benzoyl Peroxide Gel

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": "0781-3290_b553b8ab-ef4d-40ae-a5fb-a6242f2ad30a",
  "productndc": "0781-3290",
  "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; Benzoyl Peroxide Gel",
  "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": "18"
}

Related drugs

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