Vancomycin Hydrochloride

In shortageOrange BookUNIISPLATC S01AA28

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

Identification

ManufacturerHospira, Inc.

CountryUS (United States)

ATC codeS01AA28

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0409650901
1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0409-6509-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE

Annotations

UNII (FDA Substance ID)

71WO621TJD

VANCOMYCIN HYDROCHLORIDE

RxCUI 66955

Orange Book

A063076

APAP

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": "0409-6509_39396834-5ba8-43a0-8ba2-719755e332b9",
  "productndc": "0409-6509",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "063076",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 5GM BASE/VIAL",
        "product_no": "001",
        "approval_date": "Dec 21, 1990"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 10GM BASE/VIAL",
        "product_no": "002",
        "approval_date": "Sep 14, 2020"
      }
    ],
    "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": "ANDA063076",
  "marketing_category": "ANDA",
  "nonproprietary_name": "VANCOMYCIN HYDROCHLORIDE",
  "start_marketing_date": "20050606",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code S01AA28.

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