VANCOMYCIN HYDROCHLORIDE

In shortageOrange BookUNIISPLATC S01AA28

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

Identification

ManufacturerHIKMA PHARMACEUTICALS USA INC.

CountryUS (United States)

ATC codeS01AA28

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0143947410
10 VIAL in 1 PACKAGE (0143-9474-10) / 1280 mg in 1 VIAL (0143-9474-01)

Annotations

UNII (FDA Substance ID)

71WO621TJD

VANCOMYCIN HYDROCHLORIDE

RxCUI 66955

Orange Book

N210274

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; ORAL",
  "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": "0143-9474_d17179c5-783a-487a-ab74-fb8ad3eb9c34",
  "productndc": "0143-9474",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "210274",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 500MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Jan 20, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1GM BASE/VIAL",
        "product_no": "002",
        "approval_date": "Jan 20, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 5GM BASE/VIAL",
        "product_no": "003",
        "approval_date": "Jan 20, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 10GM BASE/VIAL",
        "product_no": "004",
        "approval_date": "Jan 20, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 750MG BASE/VIAL",
        "product_no": "005",
        "approval_date": "Aug 1, 2025"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1.25GM BASE/VIAL",
        "product_no": "006",
        "approval_date": "Aug 1, 2025"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1.5MG BASE/VIAL",
        "product_no": "007",
        "approval_date": "Aug 1, 2025"
      }
    ],
    "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": "mg/mg",
  "application_number": "NDA210274",
  "marketing_category": "NDA",
  "nonproprietary_name": "vancomycin hydrochloride",
  "start_marketing_date": "20250813",
  "active_numerator_strength": "1280"
}

Related drugs

Other records sharing ATC code S01AA28.

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