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United States · US · US:80725-250_4b33337a-4e4b-42f3-923f-5b61f02fc463

Humatin

Orange BookUNIISPLATC A07AA06

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

Identification

ManufacturerWaylis Therapeutics LLC
CountryUS (United States)
ATC codeA07AA06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8072525001
    100 CAPSULE in 1 BOTTLE (80725-250-01)

Annotations

UNII (FDA Substance ID)
845NU6GJPS
PAROMOMYCIN SULFATE
RxCUI 66912
Orange Book
A065173
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "845NU6GJPS",
    "rxcui": "66912",
    "inchikey": "LJRDOKAZOAKLDU-UDXJMMFXSA-N",
    "display_name": "PAROMOMYCIN SULFATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "a725f022-ec3c-430d-8021-96c861b9893c": {
      "match": "brand_token",
      "title": "HUMATIN (PAROMOMYCIN SULFATE) CAPSULE [WAYLIS THERAPEUTICS LLC]",
      "spl_version": "3",
      "published_date": "2025-11-18"
    }
  },
  "productid": "80725-250_4b33337a-4e4b-42f3-923f-5b61f02fc463",
  "productndc": "80725-250",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "065173",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "EQ 250MG BASE",
        "product_no": "001",
        "approval_date": "Dec 14, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PAROMOMYCIN SULFATE",
  "proprietary_name": "Humatin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA065173",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PAROMOMYCIN SULFATE",
  "start_marketing_date": "20210408",
  "active_numerator_strength": "250"
}

Related drugs

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