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United States · US · US:72162-1124_2d351e4f-1d0b-4021-a2b4-b2dd3243702a

Nystop

Orange BookUNIISPLATC D01AA01

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeD01AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7216211242
    15 g in 1 BOTTLE, PLASTIC (72162-1124-2)
  • ndc11
    7216211243
    30 g in 1 BOTTLE, PLASTIC (72162-1124-3)
  • ndc11
    7216211246
    60 g in 1 BOTTLE, PLASTIC (72162-1124-6)

Annotations

UNII (FDA Substance ID)
BDF1O1C72E
NYSTATIN
RxCUI 7597
Orange Book
A064118
AT
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "BDF1O1C72E",
    "rxcui": "7597",
    "inchikey": null,
    "display_name": "NYSTATIN",
    "substance_type": "mixture",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "e1b4622c-0f9f-4c00-b42c-2aa85a5e3d4f": {
      "match": "brand_token",
      "title": "NYSTOP (NYSTATIN) POWDER [PADAGIS US LLC]",
      "spl_version": "10",
      "published_date": "2025-11-17"
    }
  },
  "productid": "72162-1124_2d351e4f-1d0b-4021-a2b4-b2dd3243702a",
  "productndc": "72162-1124",
  "dosage_form": "POWDER",
  "orange_book": {
    "appl_no": "064118",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "100,000 UNITS/GM",
        "product_no": "001",
        "approval_date": "Aug 16, 1996"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NYSTATIN",
  "proprietary_name": "Nystop",
  "active_ingred_unit": "[USP'U]/g",
  "application_number": "ANDA064118",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nystatin",
  "start_marketing_date": "19960816",
  "active_numerator_strength": "100000"
}

Related drugs

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