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United States · US · US:25021-158_9b6f6171-cd0c-4468-a018-ebec650749ab

Vancomycin

In shortageOrange BookUNIISPLATC S01AA28

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

Identification

ManufacturerSagent Pharmaceuticals
CountryUS (United States)
ATC codeS01AA28
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2502115899
    1 BOTTLE in 1 CARTON (25021-158-99) / 100 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
71WO621TJD
VANCOMYCIN HYDROCHLORIDE
RxCUI 66955
Orange Book
A200837
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": "25021-158_9b6f6171-cd0c-4468-a018-ebec650749ab",
  "productndc": "25021-158",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "200837",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 5GM BASE/VIAL",
        "product_no": "001",
        "approval_date": "Aug 10, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 10GM BASE/VIAL",
        "product_no": "002",
        "approval_date": "Sep 2, 2014"
      }
    ],
    "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",
  "active_ingred_unit": "g/100mL",
  "application_number": "ANDA200837",
  "marketing_category": "ANDA",
  "nonproprietary_name": "vancomycin hydrochloride",
  "start_marketing_date": "20120920",
  "active_numerator_strength": "10"
}

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