Vancomycin Hydrochloride

In shortageOrange BookUNIISPLATC S01AA28

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

Identification

ManufacturerGland Pharma Limited

CountryUS (United States)

ATC codeS01AA28

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6808359610
10 VIAL, SINGLE-DOSE in 1 CARTON (68083-596-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (68083-596-01)

Annotations

UNII (FDA Substance ID)

71WO621TJD

VANCOMYCIN HYDROCHLORIDE

RxCUI 66955

Orange Book

A218140

APAPAP

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": "68083-596_16f3240c-d1ce-4407-ad09-565915a13805",
  "productndc": "68083-596",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "218140",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 750MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Mar 21, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 1.25GM BASE/VIAL",
        "product_no": "002",
        "approval_date": "Mar 21, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 1.5GM BASE/VIAL",
        "product_no": "003",
        "approval_date": "Mar 21, 2025"
      }
    ],
    "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/1",
  "application_number": "ANDA218140",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Vancomycin Hydrochloride",
  "start_marketing_date": "20250321",
  "active_numerator_strength": "1.25"
}

Related drugs

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