Clindamycin in 5 percent Dextrose

In shortageOrange BookUNIISPLATC G01AA10

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeG01AA10

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0143926901
1 VIAL in 1 CARTON (0143-9269-01) / 50 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

3U02EL437C

CLINDAMYCIN

RxCUI 2582

Orange Book

A214401

APAPAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Clindamycin Hydrochloride Capsule

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": "0143-9269_0dbb7c39-4e79-4a6a-9f25-d4920b2e6562",
  "productndc": "0143-9269",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "214401",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 6MG BASE/ML",
        "product_no": "001",
        "approval_date": "Apr 5, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 12MG BASE/ML",
        "product_no": "002",
        "approval_date": "Apr 5, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 18MG BASE/ML",
        "product_no": "003",
        "approval_date": "Apr 5, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLINDAMYCIN",
  "shortage_reason": "Clindamycin Hydrochloride Capsule",
  "shortage_status": "current",
  "proprietary_name": "Clindamycin in 5 percent Dextrose",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA214401",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clindamycin in 5 percent Dextrose",
  "start_marketing_date": "20240612",
  "active_numerator_strength": "18"
}

Related drugs

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