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United States · US · US:0832-0465_3984f88f-d61f-1fa9-e063-6394a90acb11

Nyamyc

Orange BookUNIISPLATC D01AA01

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

Identification

ManufacturerUpsher-Smith Laboratories, LLC
CountryUS (United States)
ATC codeD01AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    0832046515
    1 BOTTLE, PLASTIC in 1 CARTON (0832-0465-15) / 15 g in 1 BOTTLE, PLASTIC
  • ndc11
    0832046530
    1 BOTTLE, PLASTIC in 1 CARTON (0832-0465-30) / 30 g in 1 BOTTLE, PLASTIC
  • ndc11
    0832046560
    1 BOTTLE, PLASTIC in 1 CARTON (0832-0465-60) / 60 g in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
BDF1O1C72E
NYSTATIN
RxCUI 7597
Orange Book
A065183
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": {
    "01b44f91-9b68-464a-9693-b5d3e793bf3c": {
      "match": "brand_token",
      "title": "NYAMYC (NYSTATIN) POWDER [UPSHER-SMITH LABORATORIES, LLC]",
      "spl_version": "12",
      "published_date": "2025-07-11"
    }
  },
  "productid": "0832-0465_3984f88f-d61f-1fa9-e063-6394a90acb11",
  "productndc": "0832-0465",
  "dosage_form": "POWDER",
  "orange_book": {
    "appl_no": "065183",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "100,000 UNITS/GM",
        "product_no": "001",
        "approval_date": "May 3, 2005"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NYSTATIN",
  "proprietary_name": "Nyamyc",
  "active_ingred_unit": "[USP'U]/g",
  "application_number": "ANDA065183",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nystatin",
  "start_marketing_date": "20050503",
  "active_numerator_strength": "100000"
}

Related drugs

Other records sharing ATC code D01AA01.

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