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United States · US · US:72078-066_40a88420-5fcb-4715-abc5-595a18fd08d0

Vancomycin Hydrochloride

In shortageOrange BookUNIISPLATC S01AA28

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

Identification

ManufacturerMylan Institutional LLC
CountryUS (United States)
ATC codeS01AA28
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7207806699
    10 VIAL, SINGLE-DOSE in 1 CARTON (72078-066-99) / 50 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
71WO621TJD
VANCOMYCIN HYDROCHLORIDE
RxCUI 66955
Orange Book
N209481
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": "72078-066_40a88420-5fcb-4715-abc5-595a18fd08d0",
  "productndc": "72078-066",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "209481",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Jul 10, 2018"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 750MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "Jul 10, 2018"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 1.25GM BASE/VIAL",
        "product_no": "003",
        "approval_date": "Jul 10, 2018"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 1.5GM BASE/VIAL",
        "product_no": "004",
        "approval_date": "Jul 10, 2018"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1.75GM BASE/VIAL",
        "product_no": "005",
        "approval_date": "Jun 26, 2024"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 2GM BASE/VIAL",
        "product_no": "006",
        "approval_date": "Jun 26, 2024"
      }
    ],
    "appl_type": "N"
  },
  "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/40mL",
  "application_number": "NDA209481",
  "marketing_category": "NDA",
  "nonproprietary_name": "Vancomycin Hydrochloride",
  "start_marketing_date": "20240723",
  "active_numerator_strength": "2"
}

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