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United States · US · US:52536-108_461e06ca-e37d-b9fd-e063-6394a90a5ce1

Vancomycin Hydrochloride for Oral Solution

Orange BookSPL

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

Identification

ManufacturerWilshire Pharmaceuticals, Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5253610810
    1 KIT in 1 CARTON (52536-108-10) * 289 mL in 1 BOTTLE (52536-088-10) * 15 g in 1 BOTTLE (52536-098-10)

Annotations

Orange Book
N208910
AAAA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "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": "52536-108_461e06ca-e37d-b9fd-e063-6394a90a5ce1",
  "productndc": "52536-108",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "208910",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AA",
        "strength": "EQ 25MG BASE/ML",
        "product_no": "001",
        "approval_date": "Jan 26, 2018"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AA",
        "strength": "EQ 50MG BASE/ML",
        "product_no": "002",
        "approval_date": "Jan 26, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Vancomycin Hydrochloride for Oral Solution",
  "active_ingred_unit": null,
  "application_number": "NDA208910",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "vancomycin hydrochloride",
  "start_marketing_date": "20230331",
  "active_numerator_strength": null
}

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