Nystatin Oral Suspension

Orange BookUNIISPLATC D01AA01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerXttrium Laboratories, Inc.

CountryUS (United States)

ATC codeD01AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
0116402611
10 TRAY in 1 CASE (0116-4026-11) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0116-4026-05)
ndc11
0116402616
473 mL in 1 BOTTLE, PLASTIC (0116-4026-16)
ndc11
0116402650
5 TRAY in 1 CASE (0116-4026-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0116-4026-05)

Annotations

UNII (FDA Substance ID)

BDF1O1C72E

NYSTATIN

RxCUI 7597

Orange Book

A062512

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": "ORAL",
  "spl_meta": {
    "50737729-a4a4-e747-e063-6394a90adcc5": {
      "match": "brand_token",
      "title": "NYSTATIN SUSPENSION [KESIN PHARMA CORPORATION]",
      "spl_version": "1",
      "published_date": "2026-06-01"
    }
  },
  "productid": "0116-4026_4a2ff89a-52fe-8bf9-e063-6394a90a7f1d",
  "productndc": "0116-4026",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "062512",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "100,000 UNITS/ML",
        "product_no": "001",
        "approval_date": "Oct 29, 1984"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NYSTATIN",
  "proprietary_name": "Nystatin Oral Suspension",
  "active_ingred_unit": "[USP'U]/mL",
  "application_number": "ANDA062512",
  "marketing_category": "ANDA",
  "nonproprietary_name": "NYSTATIN",
  "start_marketing_date": "20260206",
  "active_numerator_strength": "100000"
}

Related drugs

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