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United States · US · US:70594-056_e49b6589-caca-4c8f-8c57-55a1ee7774cc

Vancomycin

In shortageOrange BookUNIISPLATC S01AA28

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

Identification

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

Packs · 2

  • ndc11
    7059405602
    6 BAG in 1 CARTON (70594-056-02) / 150 mL in 1 BAG (70594-056-01)
  • ndc11
    7059405603
    12 BAG in 1 CARTON (70594-056-03) / 150 mL in 1 BAG (70594-056-01)

Annotations

UNII (FDA Substance ID)
6Q205EH1VU
VANCOMYCIN
RxCUI 11124
Orange Book
N211962
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Vancomycin Hydrochloride Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "6Q205EH1VU",
    "rxcui": "11124",
    "inchikey": "MYPYJXKWCTUITO-LYRMYLQWSA-N",
    "display_name": "VANCOMYCIN",
    "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": "70594-056_e49b6589-caca-4c8f-8c57-55a1ee7774cc",
  "productndc": "70594-056",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "211962",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 500MG BASE/100ML (EQ 5MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Feb 15, 2019"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1GM BASE/200ML (EQ 5MG BASE/ML)",
        "product_no": "002",
        "approval_date": "Feb 15, 2019"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)",
        "product_no": "003",
        "approval_date": "Feb 15, 2019"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 2GM BASE/400ML (EQ 5MG BASE/ML)",
        "product_no": "004",
        "approval_date": "Feb 15, 2019"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 750MG BASE/150ML (EQ 5MG BASE/ML)",
        "product_no": "005",
        "approval_date": "May 13, 2020"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)",
        "product_no": "006",
        "approval_date": "May 13, 2020"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML)",
        "product_no": "007",
        "approval_date": "May 13, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VANCOMYCIN",
  "shortage_reason": "Vancomycin Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "Vancomycin",
  "active_ingred_unit": "mg/150mL",
  "application_number": "NDA211962",
  "marketing_category": "NDA",
  "nonproprietary_name": "Vancomycin",
  "start_marketing_date": "20200513",
  "active_numerator_strength": "750"
}

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