TYZAVAN

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
0143947006
6 BAG in 1 CARTON (0143-9470-06) / 400 mL in 1 BAG (0143-9470-01)

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": {
    "72e9c5e2-07cc-4a8b-ba64-b2e7619ea560": {
      "match": "brand_token",
      "title": "TYZAVAN (VANCOMYCIN) INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]",
      "spl_version": "3",
      "published_date": "2025-11-17"
    }
  },
  "productid": "0143-9470_720cb743-c9a5-46eb-aa72-2bcccff230aa",
  "productndc": "0143-9470",
  "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": "TYZAVAN",
  "active_ingred_unit": "g/400mL",
  "application_number": "NDA211962",
  "marketing_category": "NDA",
  "nonproprietary_name": "Vancomycin",
  "start_marketing_date": "20251017",
  "active_numerator_strength": "2"
}

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