Vancomycin Hydrochloride

In shortageOrange BookUNIISPLATC S01AA28

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

Identification

ManufacturerSTERISCIENCE SPECIALTIES PRIVATE LIMITED

CountryUS (United States)

ATC codeS01AA28

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8244900702
10 VIAL, SINGLE-DOSE in 1 CARTON (82449-007-02) / 30 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

71WO621TJD

VANCOMYCIN HYDROCHLORIDE

RxCUI 66955

Orange Book

A215324

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": "82449-007_4cab32fc-cec1-71f0-e063-6394a90a35da",
  "productndc": "82449-007",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "215324",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 750MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Oct 2, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 1.25GM BASE/VIAL",
        "product_no": "002",
        "approval_date": "Oct 2, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 1.5GM BASE/VIAL",
        "product_no": "003",
        "approval_date": "Oct 2, 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/30mL",
  "application_number": "ANDA215324",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Vancomycin Hydrochloride",
  "start_marketing_date": "20251215",
  "active_numerator_strength": "1.5"
}

Related drugs

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