Vancomycin Hydrochloride

In shortageOrange BookUNIISPLATC S01AA28

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

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC codeS01AA28

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6332331461
1 BOTTLE in 1 CARTON (63323-314-61) / 100 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

71WO621TJD

VANCOMYCIN HYDROCHLORIDE

RxCUI 66955

Orange Book

A062663

APAPAPAPAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Vancomycin Hydrochloride Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "71WO621TJD",
    "rxcui": "66955",
    "inchikey": "LCTORFDMHNKUSG-XTTLPDOESA-N",
    "display_name": "VANCOMYCIN HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "786bde33-9aec-4b4d-ba46-90bfd61956d0": {
      "match": "brand_token",
      "title": "VANCOMYCIN HYDROCHLORIDE POWDER, FOR SOLUTION [BRYANT RANCH PREPACK]",
      "spl_version": "106",
      "published_date": "2026-05-28"
    }
  },
  "productid": "63323-314_61ca1076-563b-48b2-9632-4f9a88f7639a",
  "productndc": "63323-314",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "062663",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 500MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Mar 17, 1987"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 1GM BASE/VIAL",
        "product_no": "002",
        "approval_date": "Jul 31, 1987"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 5GM BASE/VIAL",
        "product_no": "003",
        "approval_date": "Jun 3, 1988"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 10GM BASE/VIAL",
        "product_no": "004",
        "approval_date": "Nov 28, 1997"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 750MG BASE/VIAL",
        "product_no": "005",
        "approval_date": "Aug 17, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VANCOMYCIN HYDROCHLORIDE",
  "shortage_reason": "Vancomycin Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "Vancomycin Hydrochloride",
  "active_ingred_unit": "g/100mL",
  "application_number": "ANDA062663",
  "marketing_category": "ANDA",
  "nonproprietary_name": "VANCOMYCIN HYDROCHLORIDE",
  "start_marketing_date": "20041130",
  "active_numerator_strength": "10"
}

Related drugs

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