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United States · US · US:68462-955_74056e26-57fd-448e-af76-edbccfc3efb7

Vancomycin Hydrochloride

In shortageOrange BookUNIISPLATC S01AA28

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

Identification

ManufacturerGLENMARK PHARMACEUTICALS INC., USA
CountryUS (United States)
ATC codeS01AA28
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6846295551
    10 VIAL in 1 CARTON (68462-955-51) / 10 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
71WO621TJD
VANCOMYCIN HYDROCHLORIDE
RxCUI 66955
Orange Book
A205694
APAPAPAP
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": "68462-955_74056e26-57fd-448e-af76-edbccfc3efb7",
  "productndc": "68462-955",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "205694",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 500MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Jan 21, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 1GM BASE/VIAL",
        "product_no": "002",
        "approval_date": "Jan 21, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 5GM BASE/VIAL",
        "product_no": "003",
        "approval_date": "Jun 6, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 10GM BASE/VIAL",
        "product_no": "004",
        "approval_date": "Jun 6, 2023"
      }
    ],
    "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": "mg/10mL",
  "application_number": "ANDA205694",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Vancomycin Hydrochloride",
  "start_marketing_date": "20260412",
  "active_numerator_strength": "500"
}

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